. 

November 2021

Read past issues of the Global Update here

In this issue

Global E-Commerce of Foods Addressed at New Era 

of Smarter Food Safety Summit
Regulatory authorities around the globe are grappling with how to ensure the safety of 

food purchased direct to consumers using e-commerce technology, noted Mark Abdoo, 

the FDA’s Associate Commissioner of Global Policy and Strategy, as he opened the 

October 21 international panel of regulators during the FDA’s virtual New Era of Smarter 

Food Safety Summit.

The rapidly growing food e-commerce market, already accounting for $100 billion in 

sales, includes online grocery shopping and delivery; hot meal delivery; packaged meal 

ingredient delivery; and online orders for staple and exotic food items shipped from 

warehouses and vendors located anywhere and everywhere.

Associate Commissioner Mark Abdoo 

Regulators have systems for ensuring the safety of foods sold in traditional brick-andmortar grocery stores and restaurants. Now they must consider whether additional 

steps are needed for e-commerce.

Food e-commerce is a “topic that crosses borders,” Abdoo said. “Given today’s 

interconnected supply chains, the U.S. can’t achieve [its] food safety goals alone.” 

The international panel included officials from regulatory authorities in Brazil, Japan, 

Germany, and the United Kingdom. While each country has unique needs and 

perspectives that color their overall approach to regulation, they did share similar 

perspectives and what they had to say highlighted the complexity of what they all face: 

• Playing field: The e-commerce sector is very easy to enter, hence the upsurge of 

vendors. Technology businesses, who often lack interest in food safety, are entering the 

food world. Thus, it is important to hold virtual marketplaces and online service 

providers accountable, in addition to vendors.

• Old school: While traditional supply chains have been rearranged, current regulations 

are based on the traditional food paradigm. Global regulators are working, albeit 

separately, toward updated approaches for e-commerce.
• Structure: Regulatory surveillance structures vary by country. In some, the federal 

authority leads, with state support. In others, state and local authorities have the greater 

onsite responsibility, looking to the federal authority to coordinate.

• Scope: It’s not just foodstuffs. Dietary supplements (often the responsibility of food 

regulators) are popular e-commerce purchases, and are more likely to have unsafe 

claims and formulations.

• Last mile: The critical need for appropriate and protective packaging and adherence 

to safe food delivery temperatures poses challenges, as these issues expand the scope 

of who needs oversight, and bumps up against what is currently practical for the 

delivery sector.

• Cooperation: Cooperation and discussion is needed with other regulatory authorities, 

institutions, industry groups, consumer rights groups, and judiciary authorities.

• Outreach: Outreach, education, and training is important for industry, health agencies, 

and e-commerce platform providers.

The challenges regulators face are due, in part, to the lack of

international standards and controls for food (and 

supplements, and pharmaceuticals, etc.) sold via ecommerce.

Fabio Miranda da Rocha, a senior Public Health Officer in the Food Inspection 

Department of the Brazilian Health Regulatory Agency, noted that his agency would be 

able to better manage oversight of e-commerce if international standards existed to 

allow for rapid information exchange since “online sales happen faster than authorities 

can communicate about it.” 

[A Federal Register docket was opened for the Summit to collect comments from the 

public, industry, and global colleagues. It closed on November 20, 2021. Read what 

people had to say here.] 

OGPS Secures Support for a WHO Global Working 

Group on Informal Markets 

Informal markets — where vendors congregate to sell a wide variety of products from 

market stalls, push carts and small retail shops — are the primary source for locally 

produced food, crafts, clothing and other products in low- and middle-income countries.

In areas that lack access to an approved pharmacy or medical facility, some vendors 

also sell medicines, meeting a market demand for convenient and accessible 

medicines. Often they provide the medications on an as-needed basis and are sold by 
the pill or in small amounts that are devoid of any packaging, an approach that would be 

illegal in pharmacies or in formal markets with packaging restrictions.

These markets tend to be loosely regulated by local authorities and are not overseen by 

national regulatory authorities. Such lack of oversight, combined with limited pharmacy 

knowledge, and a potentially questionable supply chain, raises the risk that people in 

these markets are buying substandard and/or falsified medications. 

The FDA’s Office of Global Policy and Strategy (OGPS) has taken an interest in this 

issue ever since it was initially raised in the National Academies for Sciences, 

Engineering, and Medicine’s 2020 report entitled, "Stronger Food and Drug Regulatory 

Systems Abroad" (commissioned by the FDA). After conducting additional research, 

OGPS developed a proposal that informal markets be one of the 2022-23 prioritized 

activities for the World Health Organization’s Member State Mechanism on Substandard 

and Falsified Medical Products (MSM).

In late October, at its 10th meeting, the MSM — a global forum that convenes, 

coordinates, decides, and organizes activities addressing substandard and falsified 

medical products — accepted the FDA’s prioritized new activity. Member countries now 

have until early December to review the MSM’s full 2022-23 work plan — and come up 

with projects under the prioritized activities, including the one on informal markets. In 

the meantime an informal markets working group has been established and more than 

10 countries have asked to join. A chair has yet to be selected.

The 2020 National Academies report highlighted Tanzania’s successful approach to 

informal markets – an accreditation program for informal sellers established by the 

Tanzania Medicines and Medical Devices Authority in 2003. By the time the 2020 report 

was issued, Tanzania had accredited over 9,000 drug dispensing outlets. To gain 

accreditation, store owners and dispensing staff are required to complete training in 

health, communication and patient counseling, as well as local pharmacy laws, good 
. 

dispensing practices, and rational use of medicines. As an incentive to participate, shop 

owners are authorized to sell a limited list of restricted medicines and are eligible for 

business improvement loans. The program has improved access to medicines and the 

quality and appropriate use of these products. As a result, there has been a substantial 

increase in the number of people who adhere to malaria treatment guidelines.

There are a variety of potential projects for the informal markets working group to 

pursue, including a study to determine underlying causes of impacts of various 

intervention methods, a survey of member states on the prevalence of such markets, a 

tool kit to help regulatory authorities address medical product distribution through 

information markets, and the development of an awareness/education campaign for 

consumers.

OGPS International Policy Analyst Russell Campbell, who oversees the FDA’s MSM 

work, said he expects the working group to take approximately five years to address the 

issues outlined in the OGPS proposal.

African Medicines Agency to Become a Reality

After years of discussion, Africa is getting an African Medicines Agency. Instead of 

acting as a stand-alone regulatory body, like the FDA, it will coordinate the activities of 

national and regional regulators as well as support local manufacturing and pharmacy, 

and act against substandard and falsified medicines.

The Treaty for the Establishment of the African Medicines Agency (AMA) entered into 

force on November 5. The AMA will operate as a special agency under the African 

Union, a 55-member-state continental union dedicated to achieving greater unity, 

cohesion, and solidarity across the continent.

The idea for the AMA was first discussed in 2010 at the 60th session of the World 

Health Organization Regional Committee for Africa. But African leaders didn’t formally 

act on these discussions until the 32nd Ordinary Session of the Assembly in Addis 

Ababa, Ethiopia when they signed the AMA treaty
To date, 16 African Union member states (Algeria, Benin, Burkina Faso, Cameroon, 

Chad, Gabon, Ghana, Guinea, Mali, Mauritius, Namibia, Niger, Rwanda, Seychelles, 

Sierra Leone, and Zimbabwe) have completed all of these steps. Another member 

state, Morocco, has ratified the treaty but has yet to deposit their instrument of 

ratification with the Commission. Eleven other states have signed the treaty: Burundi, 

Cote d’Ivoire, Egypt, Madagascar, Republic of Congo, Saharawi Arab Democratic 

Republic, Senegal, Tanzania, Togo, Tunisia, and Uganda.

Thirteen countries are said to be interested in hosting the AMA’s headquarters. A site 

decision is expected to be made in February 2022 at the AU Summit. After that, formal 

AMA structures need to be set up and money raised to support the AMA’s activities.

The AMA builds on the efforts of the African Medicines Regulatory Harmonization, 

established in 2009 by the Africa Union Development Agency - the New Partnership for 

Africa's Development (AUDA-NEPAD) to achieve regulatory harmonization among the 

AU member states. AUDA-NEPAD has been a strong advocate for the AMA. On its 

website, it states that once the AMA is fully operational the new agency will:

• Support the growth of local pharmaceutical production and play a critical 

role in catalyzing regional trade.

• Evaluate medical products for the treatment of priority diseases as 

determined by the African Union.
• Regularly inspect, coordinate and share information about products that

are authorized for marketing.

• Coordinate joint reviews of clinical trial applications for vaccines and

assessment of "highly complex" product dossiers such as biosimilars.

• Coordinate joint inspections of Active Pharmaceutical Ingredients (API)

manufacturing sites.

• Collaborate with Regional Economic Communities and National Medicines

Regulatory Authorities in the identification of substandard and falsified

medical products.

• Facilitate information sharing across countries and develop common

standards and regulations and in turn be responsible for harmonizing

legislation.

Michel Sidibé, a former executive director of the Joint

United Nations Programme on HIV and AIDS (UNAIDS)

and former Minister of Health in Mali, was appointed by

the AU in April as a special envoy to help secure the 15 

countries needed for the establishment of the AMA.

He has been quoted as saying that he seeks U.S. partnership and collaboration to help 

standardize and harmonize AMA regulations in accordance with international norms and 

to strengthen Africa’s network of laboratory systems. 

In August, FDA senior officials and 

staff met with Jessica Lapenn, U.S. Ambassador to the 

African Union and U.S. Permanent Representative to the 

United Nations Economic Commission for Africa, to 

discuss future plans for working with the AMA once it was

operational.

“The U.S. government and U.S. private sector are very

much looking forward to collaboration with AMA,” Lapenn 

was quoted as saying at a recent media briefing sponsored 

by the Africa Centres for Disease Control, which until now

has been the lone public health agency under the African 

Union.

Additional Resources 

African Union press release
AMA treaty infographic

COFEPRIS Becomes Latest ICH Member

Mexico’s Federal Commission for the Protection against Sanitary Risk (COFEPRIS) 

has become a member of the International Council on Harmonization (ICH), a 

nonprofit group that brings regulatory authorities and the pharmaceutical industry 

together to harmonize the scientific and technical aspects of drug registration.

COFEPRIS, a decentralized agency of Mexico’s Department of Health, regulates 

pharmaceutical products, medical devices, biological products, pesticides and 

fertilizer, food, cosmetics, and tobacco.

ICH member countries approved Mexico's nomination without objection at the 

organization’s plenary meeting, COFEPRIS said in a November 17 press release.

Twitter exchange between @FDA_Global and Cofepris 

Mexico is the fourth country in the Americas to become an ICH member, joining 

Canada, Brazil, and the United States, and is ICH's first Spanish-speaking nation. 

In his speech before the virtual assembly, the head of Cofepris, Alejandro Svarch 

Pérez, highlighted the role of Cofepris in protecting the health of the more than 129 

million people who live and transit in the country, as well as its neighbors in Central 

America and the Caribbean.

"It is our priority to align our processes with international best practices to facilitate 

access to medicines, especially for our most vulnerable population. We work to provide 

safe, effective and quality medicines in our country, and we are sure that harmonization 

is a crucial element for the proper functioning of health systems," said Svarch Pérez.

Becoming a member of ICH is a key step in strengthening the regulation of 

pharmaceuticals and clinical research throughout the region, which will facilitate earlier 

and more equitable access to innovative therapies, he added. 

FDA Collaborates with Health Canada and the UK’s 

MHRA on Good Machine Learning Practice

The FDA, Health Canada, and the United Kingdom’s Medicines and Healthcare 

products Regulatory Agency (MHRA) have jointly identified 10 guiding principles that 

can inform the development of Good Machine Learning Practice.

These guiding principles will help promote safe, effective, and high-quality medical 

devices that use artificial intelligence and machine learning, they said in an October 27 

statement. 
Artificial intelligence and machine learning technologies have the potential to transform 

health care by deriving new and important insights from the vast amount of data 

generated during the delivery of health care every day. They use software algorithms to 

learn from real-world use and in some situations may use this information to improve 

product performance. But they also present unique considerations due to their 

complexity and the iterative and data-driven nature of their development.

“With artificial intelligence and machine learning progressing so rapidly, the three 

regulatory agencies see a global opportunity to help foster good machine learning 

practice by providing guiding principles that we believe will support the development 

and maturation of good machine learning practice,” said Bakul Patel, director of the 

FDA’s Digital Health Center of Excellence in the Center for Devices and Radiological 

Health. 

Good Machine Learning Practice for Medical Device 

Development: Guiding Principles

Multi-Disciplinary Expertise are 

Leveraged Throughout the Total 

Product Life Cycle

Good Software Engineering and 

Security Practices are Implemented

Clinical Study Participants and Data 

Sets are Representative of the 

Intended Population

Training Data Sets are Independent 

of Test Sets

Selected Reference Datasets are 

Based Upon Best Available Methods

Model Design is Tailored to the 

Available Data and Reflects the 

Intended Use of the Device

Focus is Placed on the Performance 

of the Human-AI Team

Testing Demonstrates Device 

Performance during Clinically 

Relevant Conditions

Users are Provided Essential 

Information Clearly

Deployed Models are Monitored for 

Performance and Re-training Risks 

are Managed

Since many digital health care tools operate in the cloud, outside physical or country 

boundaries, the FDA believes it is important that regulatory expectations for these 

products be harmonized globally and that regulators work together as much as possible 

on a common set of industry standards and best practices. 

The 10 principles are intended to identify areas where alignment in efforts related to 

research, building educational tools and resources, regulatory policies, regulatory 

guidelines, international harmonization, and consensus standards could be developed 

by the International Medical Device Regulators Forum (IMDRF), international standards 

organizations, and other collaborative bodies to advance the maturation of GMLP.
IMDRF is a voluntary group of medical device regulators from around the world that 

work together to accelerate international medical device harmonization and 

convergence. The FDA helped introduce a new paradigm within IMDRF for an 

internationally harmonized approach to Software as a Medical Device, which 

includes mobile medical applications. Currently, the agency participates in the IMDRF’s 

Artificial Intelligence Medical Devices working group, which seeks to achieve a 

harmonized approach to the management of artificial intelligence and machine learningenabled medical devices. 

The FDA has established a public docket (FDA-2019-N-1185) at Regulations.gov to 

solicit feedback on the guiding principles. 

FDA, HHS, and Colombian Government Hold Dialogue 

on Device Harmonization and Vaccine Development

Medical device harmonization and vaccine development were the primary topics of 

a working group meeting between U.S. public health officials and public health officials 

from the Colombian government on October 24-26 in Bogotá, Colombia. 

The FDA’s Latin America Office (LAO) Director Katherine Serrano represented the FDA 

as part of the U.S. Department of Health and Human Services delegation. The threeday meeting was held in conjunction with the Ninth High-Level Dialogue between the 

two countries, kicked off by U.S. Secretary of State Anthony Blinken and Colombia Vice 

President and Foreign Minister Marta Lucía Ramírez.

The working group made significant headway in advancing medical device 

harmonization — encouraging Colombia to adopt internationally recognized medical 

device quality system standards.

According to Serrano, the FDA has been an ardent supporter of international regulatory 

convergence, in the hope that it will facilitate more efficient development, manufacture, 

and marketing of medical devices worldwide. For Colombia, convergence will help lay 

the groundwork for participating in international programs, including the Medical Device 

Single Audit Program (MDSAP), which allows an MDSAP-recognized auditing 

organization to conduct a single regulatory audit of a medical device manufacturer that 

can satisfy the relevant requirements of the regulatory authorities participating in the 

program. MDSAP’s current participants include Australia, Canada, Brazil, Japan, and 

the U.S.
Vaccine Capacity Building

At the working group meeting, Colombia requested support and training from the FDA 

on vaccine regulation and capacity building to help the country build sustainable 

solutions to the public health challenges revealed by the pandemic. Colombia previously 

manufactured vaccines against rabies and yellow fever (among others), with enough 

capacity to supply the region, but production stagnated in recent decades. Both 

Colombia’s government and its pharmaceutical sector are now taking steps to futureproof the country’s — and thus Latin America’s — vaccine production ability.

China’s NMPA Begins Process of Joining Global 

Inspectional Group

China’s primary regulatory agency for pharmaceuticals, medical devices, and 

cosmetics, the National Medical Products Administration, or NMPA, has begun the 

process of becoming a full member of an informal group of global regulatory authorities 

who work toward harmonizing inspection procedures.

That informal global group is known as the Pharmaceutical Inspection Co-operation 

Scheme, or PIC/S, founded in 1995 to lead in the international development, 

implementation, and maintenance of harmonized Good Manufacturing Practice 

standards and quality systems that regulatory authorities adhere to when inspecting 

manufacturing facilities that make medical products.
The NMPA was created in 2018 following a reorganization of the China Food and Drug 

Administration, which had participated in PIC/S-related activities for several years but 

had never sought formal membership. Since its reorganization, the NMPA has put more 

emphasis on international harmonization efforts, including harmonizing its own systems 

to international standards. In 2019, it met with PIC/S about a possible membership, and 

that led to its September 2021 pre-accession request. Pre-accession is a preliminary 

process designed to help applicants better understand the relevant requirements of the 

PIC/S before applying for full membership, or what PIC/S calls being a “participating 

authority.”

The pre-accession period can take up to two years. During this 

time, PIC/S will perform a gap analysis to identify whether the 

applicant fulfills all of the organization’s requirements for 

membership. If PIC/S decides to invite the NMPA to apply for 

membership, the Chinese authority would become the 

organization’s 55th member.

FDA’s Global Messaging Nearly Doubles
Whenever the FDA issues announcements of interest to the international community, 

the Office of Global Policy and Strategy (OGPS) sends an email alert to the 22,000 

addresses in its international listserv, which includes embassies based in Washington, 

D.C., in addition to the thousands of individuals who subscribe to this free service.

These alerts, known as a Dear International Colleague Letter (DICL), have been issued 

by OGPS, and its predecessor, the Office of International Programs, for nearly two 

decades.

The number of DICLs has been on the rise in recent years, as other FDA offices have 

come to recognize their communications value and as the OGPS’ Communications 

Team has devoted more time to working with other FDA offices on international 

messaging.

In fiscal year 2021, OGPS issued a record number of DICLs, nearly double the 38 

DICLs in fiscal year 2020 (clearly an anomaly year) and 20% higher than the 48 DICLs 

issued in FY 2019.

Q-1 Q-2 Q-3 Q-4

DICLs Oct-Dec Jan-Mar Apr-Jun Jul-Sept Total

FY2017 7 14 10 10 41

FY2018 10 13 9 15 47

FY2019 8 5 19 16 48

FY2020 8 10 6 14 38

FY2021 19 13 17 11 60

The 60 DICLs issued in FY 2021 covered a variety of topics, including information about 

upcoming webinars, food safety actions, and new drug and device regulations. But what 

helped to drive the recent increase and made FY 2021 unique was the FDA’s extensive 

messaging on its COVID-19 activities, including its groundbreaking decisions about 

COVID-19 vaccines.

Nalubola Engages Croatian Stakeholders
Dialogue Concludes with Two Signed MOUs

The FDA’s India Office was part of a U.S. delegation of public health officials who 

participated in the 4th U.S.-India Health Dialogue in New Delhi on September 27-28.

The event provided an opportunity for the U.S. officials to discuss multiple ongoing 

collaborations with their Indian counterparts, including epidemiological research and 

surveillance, vaccine development, One Health, zoonotic and vector-borne diseases, 

food and drug regulations, health systems, and health policies.
INO Director Sarah McMullen shared information about the FDA’s ongoing collaboration 

on efforts to enhance medical products and food safety with its Government of India 

counterparts. The FDA also held a sideline meeting regarding medical products with the 

Central Drugs Standard Control Organisation, India’s national regulatory body for 

pharmaceuticals and medical devices.

The U.S. delegation was led by Patricia Lacina, Charge D’Affairs of the U.S. Embassy 

New Delhi, and Loyce Pace, director of the Department of Health and Human Services 

(HHS) Office of Global Affairs.

Two Memoranda of Understandings were signed on the last day: one between the 

India’s Ministry of Health & Family Welfare and HHS that called for cooperation in health 

and biomedical sciences; another, between the Indian Council of Medical Research and 

the U.S. National Institute of Allergy and Infectious Diseases, regarding cooperation on 

the International Centre for Excellence in Research.

In concluding remarks, Union Health Minister, Shri Mansukh Mandaviya, cited ongoing 

collaboration between the two countries on many pressing health issues, including 

antimicrobial resistance, HIV/AIDS, and climate change and human health, as well as 

the importance of engagement with the FDA to better understand the PREDICT Model, 

a risk-based management tool to enhance the safety of U.S. imports.

"Both India and the U.S. are global partners, and we also need to work collaboratively in 

reforming the global health architecture, whose fault lines have become amply visible 

during the current pandemic," Mandaviya said. "I also note with satisfaction the 

increased convergence between the regulators of both countries and look forward for 

further tangible outputs and combined working on this issue at global fora."
Foreign Office Network Launched

FDA staff who have worked in an FDA foreign office now have the opportunity to join 

the Foreign Office Alumni Network. 

The new Network is part of the FDA Alumni Association, which is dedicated to helping 

current and future FDA alumni stay in touch with each other and the issues of the day, 

and support the agency’s public health mission by providing a venue for sharing the

collective wisdom of the FDA’s “brain trust.” 

Both current and former FDA foreign office staff, including locally employed staff, qualify 

for membership. Those who join will receive the Association’s newsletter, access to 

targeted events, and be added to a members-only listserv. 

Associate Commissioner for Global Policy and Strategy Mark Abdoo sent an email to 

qualifying staff on November 16, alerting them to the membership opportunity which, he 

said, would allow them to reflect on and share their unique experiences. 

“Living and working abroad...and serving as a U.S. diplomat, is a special opportunity to 

truly experience another culture, to meet and get to know foreign counterparts, and to 

develop new contacts and friendships,” he said.

“At the end of a foreign tour, it is hard for staff to say goodbye to a once-in-a-lifetime 

experience and to the many new friends and colleagues they met at post.”
. 

Over time, the new network could fulfill a mentorship function — helping to develop the 

next generation of foreign office employees and encouraging the recruitment and 

retention of foreign office staff, Abdoo added. 

The Foreign Office Alumni Network was spearheaded by Leigh Verbois, former director 

of OGPS’ China Office, and former director of the Office of Global Operations, who now 

works in the Center for Drug Evaluation and Research as the director of the Office of 

Drug Security, Integrity, and Response. 

Those who have questions about the network may contact Leigh.Verbois@fda.hhs.gov
Thomas Siebertz has been selected as a consumer safety 

officer with the China Office. He will specialize in human and 

animal food.

He joins OGPS from the Office of Regulatory Affairs’ Office of 

Human and Animal Food Operations, where he was part of 

HAF-East 1, located in Stoneham, Massachusetts.

Siebertz has been an FDA consumer safety officer since 2014, conducting inspections 

of food, cosmetic, and dietary supplement firms both domestically and internationally. 

He also has experience with the Center for Food Safety and Applied Nutrition as an 

international policy analyst where he worked on the Systems Recognition program.

He holds a Master of Public Health degree in environmental health science from New 

York Medical College and a bachelor’s degree in food science from Kansas State 

University. Siebertz is an adjunct faculty of food science at Bay Path University in 

Longmeadow, Massachusetts.

Grant Jones has been selected as a consumer safety officer

with the China Office, specializing in human and animal food.

He joins OGPS from the Memphis Resident Post in Jackson,

Mississippi where he conducted food inspections for the Office

of Regulatory Affairs (ORA).

Jones has been an FDA consumer safety officer since 2016. FDA service is a family 

tradition: Jones’ father is an FDA investigator for ORA’s Office of Pharmaceutical 

Quality Operations Division 2. As a result, Jones had the unique opportunity to assist in 

a follow-up inspection where the senior Jones was lead investigator.

He holds a bachelor’s degree in chemistry from Mississippi College, and is currently 

studying Christian theology.
Charles E. Idjagboro has been selected as a consumer safety 

officer specializing in human and animal food and will be 

stationed with the China Office.

He joins OGPS from the Center for Food Safety and Applied 

Nutrition where he was a Retail Food Policy Team 

representative since 2017.

Idjagboro also spent five years as a consumer safety officer with the Office of 

Regulatory Affairs Baltimore District, where he led and conducted domestic and foreign 

inspections.

He has provided technical expertise to new hires and senior management regarding 

compliance inspections of FDA regulated foods including conventional, acidified, juice, 

seafood, and dietary supplements.

Idjagboro holds a Master of Public Health degree in epidemiology from the University of 

Maryland Baltimore School of Medicine, and a Bachelor of Science Degree in zoology 

from the University of Benin, Benin City, Edo State, Nigeria. 

Micah Augusma was selected as an ORISE fellow for the 

OGPS immediate office to provide support on research and 

analysis projects. He completed an undergraduate degree in 

medical anthropology from the University of Iowa in 2019.

During his undergraduate studies Augusma was actively 

involved in student government where he served as the 

student government director of health and safety.

In this role he collaborated with university officials to develop health programming and 

mental health resources for students.

In Spring 2021, Micah graduated from Emory University’s Rollins School of Public 

Health where he received a Master of Public Health in global health with a concentration 

in infectious disease. While at Emory he served as a graduate research assistant for the 

CDC’s Office of Science where he conducted qualitative data implementation, 

qualitative data analysis, and improvements in regulatory compliance systems.

Augusma also conducted research on global sanitation systems through the Center for 

Global Safe Water, Sanitation, and Hygiene at Emory. In 2020, he helped the Center 

and World Vision Zambia develop a novel sanitation data collection tool used to provide 

context on sanitation in the rural areas of Zambia. Aside from WASH topics (i.e., water, 
sanitation, and hygiene), his other global health interests include vector-borne diseases, 

global health security, and global health diplomacy.

Kukhwa “Kristie” Oh was selected as an ORISE fellow for 

the OGPS immediate office to provide support on research 

and analysis projects.

She is a pharmacist by training who is keen to work on global

health policy development in OGPS. Prior to attending 

pharmacy school, she graduated from Chung-Ang University

in South Korea with a bachelor’s degree in music, 

specializing in classical piano.

Before going to Germany to study for her doctorate, she had the opportunity to go on a 

mission trip to Mongolia with a medical team. 

The experience opened her eyes to see how powerful access to medicine was, and how 

it can positively impact the rural community. After the mission trip, she changed her 

career goals and came to America to study biochemistry at Mercer University and 

eventually graduated from Notre Dame of Maryland University with a Pharm.D.

While serving as the chapter President of the APhA-ASP- American Pharmacists 

Association Academy of Student Pharmacists, she initiated the women's health 

operation and spearheaded an initiative that collected over 200 feminine care packages 

for Paul's Place in Baltimore.

Following are the most recent Dear International Colleague Letters:

Pharmaceutical Quality Symposium 2021: Innovations in a Changing World

Drug Export Certificates – CPPs – to be issued electronically

FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines

FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 

through 11 Years of Age (IDICL)
. 

Coronavirus (COVID-19) Update: FDA Updates Test Policies to Help to Ensure 

Accuracy and Reliability of Tests and Increase Access to At-Home Tests

FDA expands eligibility for COVID-19 Vaccine boosters

UPCOMING EVENTS

December 1 World AIDS Day

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