July 2021

Fristedt Calls for Strengthening Local Production, 

Adoption of FDA-Backed Device Nomenclature at 

WHA 

FDA Deputy Commissioner for Policy, Legislation, and International Affairs Andi 

Fristedt represented the FDA at the 74th World Health Assembly (WHA) on May 28 as a 

member of the U.S. delegation led by the Health and Human Services (HHS) Secretary 

Xavier Becerra. 
The WHA is the governing body of the World Health Organization (WHO). Delegations 

led by the health ministers from the WHO’s 194 Member states participate in the WHA’s 

annual meeting. The agenda is prepared by the WHO’s Executive Board. 

In her remarks to the WHA, Fristedt said, “The COVID-19 pandemic has demonstrated 

the urgent need to strengthen global supply chains, including through enhanced 

sustainable and strategic regional and local production, strengthened regulatory 

systems to enable access to quality assured products, and facilitation of trade in key 

health products.”

The United States cosponsored a resolution calling for strengthening local production of 

medicines and other health technologies to improve access, she said, adding that 

strong regulatory systems are a precursor for local production to contribute to greater 

access.

Although United States believes strongly in intellectual property protections, it supports 

a waiver of those protections for COVID-19 vaccines, in service of ending the pandemic, 

she said, explaining that “the extraordinary circumstances of the COVID-19 pandemic 

call for extraordinary measures.”

Seventy-fourth World Health Assembly – 28 May 2021 

Fristedt also addressed implementation of a harmonized nomenclature system for 

naming medical devices, that regulators, health care providers, and others use to 

exchange medical device information and support patient safety. Such a system can be 

useful in the exchange of post-market safety reports, supporting inventory control in 

hospitals, and for purchasing and supply chain management.
The FDA supports the free Global Medical Device Nomenclature system, under 

development since the 1990s, that is now being used by 70 national medical device 

regulators from across all WHO regions. In this nomenclature system, information in the 

form of a five-digit numeric GMDN Code is cross-referenced to a precisely defined Term 

Name and Definition. The European Union has chosen to adopt its own European 

Medical Devices Nomenclature instead and the WHO has proposed to adopt that 

version, once it is finalized by the EU. “We remain deeply concerned” by the WHO’s 

proposal, Fristedt said, noting that the EMDN is not harmonized with the GMDN system. 

To address that issue, she urged that the WHO complete the following actions before 

proceeding:

Comprehensively map the proposed new EMDN-based nomenclature system against 

the already widely used GMDN to identify and minimize the negative impacts of a 

duplicate system on Member States, medical device manufacturers, and other 

stakeholders.

Conduct a costing exercise so that Member States understand the resource 

requirements for WHO to host, maintain and update a system to ensure its continued 

value for member States and stakeholders.

Continue its cooperation with the International Medical Device Regulators 

Forum (IMDRF) towards developing a harmonized approach to nomenclature and to 

consult with regulatory authorities, medical device manufacturers, and other appropriate 

stakeholders.

Regulators Share a Common Goal in First-Ever 

Generic Drug Cluster

The FDA’s Office of Generic Drugs (OGD), part of the Center for Drug Evaluation and 

Research (CDER), is spearheading an effort to more closely align the way the world’s 

major regulatory agencies oversee generic drugs. To do that, OGD has established the 

Generic Drug Cluster, the first forum for regulators to routinely meet and discuss 

generic drug development globally.

Through the auspices of the cluster, regulators will have an opportunity to:

• Advance robust science-based approaches to generic drug regulation.

• Achieve a common understanding of each agency’s regulatory requirements for 

approval as well as current thinking on topics related to generic drug 

development.
• Seek opportunities to align on innovative bioequivalence approaches that support 

complex generic drug approvals.

• Confidentially share reports on safety issues to support the global safety of 

generic drugs.

Generic drugs are therapeutically equivalent to brand name drugs. Since they were 

established under the Drug Price Competition and Patent Term Restoration Act of 1984 

(Hatch-Waxman) they have grown to account for about 90% of prescriptions filled in the 

United States. The FDA is committed to helping facilitate access to lower-cost generic 

medicines by taking steps to enhance and streamline the development and approval 

process of high-quality generic drugs.

How did it start?

While the idea of a cluster is not new, the initiative to stand up a cluster dedicated to 

generic drug development is new — and is the innovative concept of Sarah Ibrahim, 

Ph.D., who became associate director of Global Generic Drug Affairs last year. Ibrahim 

worked closely with both CDER’s international staff and staff from the Office of Global 

Policy and Strategy who supported her efforts to understand the current global 

environment. Ibrahim credits her colleagues and is appreciative of their support. “It 

takes a village and the dedication and collaboration in OGD and the support of its 

leadership, truly exemplifies the organizational excellence. OGPS and CDER 

international [staff] were pioneers in helping me establish the cluster.”
Who is involved?

The cluster is currently limited to government regulatory authorities and includes 

participants from the FDA; the European Medicines Agency; Health Canada; Medicines

and Healthcare products Regulatory Agency of the United Kingdom; Swissmedic; and 

the Israeli Ministry of Health. The nature of the cluster, given the need for confidential 

information-sharing, is limited to regulatory agencies that the FDA has identified as 

partners with the appropriate confidentiality commitments in place.

In the future, observers from other regulatory authorities may participate in cluster 

activities – subject to the agreement of the FDA and all the founding regulatory 

agencies – provided they, too, have the appropriate confidentiality arrangements in 

place, Ibrahim says.

Why do it?

One of today’s challenges for FDA centers is around development programs for 

complex generics. These are generic drugs that could have a complex active ingredient; 

complex formulation; complex route of delivery; or a complex drug device combination. 

If generic regulation was more closely aligned, companies could operate more efficiently 

and at greater scale. This is especially important when it comes to complex generic 

drugs that might serve only a small number of patients in any given market. While the 

market might be prohibitively small in one country, it might be economically viable if sold 

in multiple markets with comparable regulatory requirements.

“As an agency, we value global collaboration and we recognize that with certain 

products such as complex generics that face a more complicated development process, 

access to multiple markets offers an incentive for companies to move forward with a 

development program,” Ibrahim said. Additionally, in part of the Generic Drug User Fee 
Amendments (GDUFA) negotiations, industry repeatedly pointed out that there is no 

clear regulatory expectation for complex generics, making it a global unmet need.

For now, the variations in approach can be striking. For example, other regulators 

describe complex generics as hybrid generics and have distinct authorization and 

submission requirements.

Complex generics can greatly reduce health care costs. For instance, FDA approved 

the first generic Advair Diskus (a complex generic drug device combination product for 

asthma and COPD) in January of 2019. When it was introduced to the U.S. market, the 

out-of-pocket cost was reportedly half that of the brand product.

What is the end goal?

Regulatory agencies are unified by the mission of promoting the health of our citizens 

and ensuring that global quality and safety standards are met. Our path to 

harmonization of scientific and technical standards require an understanding of how 

generics are regulated across the world. Conducting a gap analysis is the first project 

for the cluster by determining how generic drugs are regulated across the globe.

The inaugural cluster session was held on June 15, with subsequent meetings to be 

held on an approximately quarterly basis. “At the end of the day we are working to 

ensure patients have access to safe, affordable, and effective medications,” said 

Ibrahim.

Inaugural Meeting of the Joint Sectoral Committee 

Commences

The United States-United Kingdom Mutual Recognition Joint Sectoral Committee (JSC) 

held its inaugural meeting on June 11, discussing next steps since the Mutual 

Recognition Agreement between the two nations went into effect early this year.

Before “Brexit” – the United Kingdom’s official exit from the European Union – the UK 

had been part of the EU’s mutual recognition agreement with the U.S., allowing foreign 

regulatory authorities to rely upon each other’s Good Manufacturing Practice (GMP) 

surveillance inspections of drug facilities.
After Britain signaled that it was leaving the EU, the 

U.S. began work on establishing a comparable 

MRA with the UK. 

The US-UK Mutual Recognition Agreement (MRA) 

was signed on February 14, 2019, and entered into 

force on January 1, 2021, the day on which Britain 

left the EU.

Associate Commissioner Mark Abdoo led the FDA delegation at the inaugural meeting 

of the Committee this month. A key objective of the first JSC meeting was to consider 

the addition of veterinary medicines into the scope of the MRA.

Also attending the meeting for the FDA were representatives from the Center for 

Veterinary Medicine (CVM), Office of Regulatory Affairs (ORA); and OGPS’ Office of 

Trade, Mutual Recognition and International Arrangements (OTMRIA) and Europe 

Office (EO).

The UK delegation included representatives from the Medicines and 

Healthcare products Regulatory Agency and the Veterinary Medicines Directorate. 

The framework of the partnership is maintained by the National Institute of Standards 

and Technology, which oversees inspectional collaborations involving 

telecommunications equipment and electromagnetic compatibility.

CDRH Releases Report on South Korea’s COVID-19 

Response

Just like public health experts around the world, officials in the FDA’s Center for Devices 

and Radiological Health were impressed that South Korea was able to contain its 

COVID-19 outbreak two months after the first case of the disease was confirmed in 

early 2020, even though the nation was then the second most infected country after 

China. CDRH set out to determine why South Korea was able to accomplish this and 

learned that the nation’s success was largely attributable to having a national testing 

strategy in place. These findings were published in a 25-page report that CDRH 

released in late May.

In addition to the report, CDRH Director Jeffrey Shuren, M.D., J.D., and Timothy 

Stenzel, M.D., Ph.D., who directs the CDRH office that oversees diagnostic products, 

wrote a blog for the public health publication Health Affairs that summarizes the report’s 

findings.
“Much of South Korea’s success in addressing the current pandemic has been 

attributed to lessons learned from their response to a deadly outbreak of Middle East 

Respiratory Syndrome (MERS) in 2015, including a national testing strategy,” the two 

wrote. 

The CDRH officials identified five initiatives that contributed to South Korea’s successful 

testing strategy:

• Investing early in the commercial development of diagnostic tests for infectious 

diseases.

• Guaranteeing the purchase of minimum quantities of tests and reimbursing once 

the tests were authorized.

• Streamlining test validation studies

• Developing a centrally coordinated, nationwide testing program that relied upon a 

few dozen authorized tests commercially manufactured in high volumes, and

• Creating a network of testing sites.

The FDA recognizes different approaches may work for different countries, and the 

report does not make recommendations for what approaches could or should be 

adopted in the U.S. for emerging infectious diseases, the officials said.
Reconvening Inspections in Mexico Makes an 

Immeasurable Impact

Last year in March, the FDA announced a temporary postponement of all domestic and 

foreign routine surveillance facility inspections, while continuing mission-critical 

inspections when possible. This precaution resulted in a hiatus of produce inspections 

in the Latin America region.

Due to ongoing foreign travel restrictions, consumer safety officers assigned to 

the Office of Regulatory Affairs (ORA) are still not able to conduct foreign inspections at 

this time. Thankfully, OGPS’ Latin America Office (LAO) could dispatch Janete Oliveira, 

a CSO in Mexico City, who is fully trained in produce-related operations and has 

previous experience conducting produce inspections and outbreak investigations.

Oliveira was excited about being able to conduct the FDA’s first onsite inspection in the 

Latin America region after more than a year. “It's been really nice to be able to go back 

to the field and perform these inspections – having my [LAO] leadership, OGPS 

leadership, and ORA leadership believe that I can put out some quality work without the 

need to wait until the next growing season.”

LAO has resumed inspections in Mexico by targeting produce operations as a high priority commodity for the FDA in that country. 

LAO’s Janete Oliveira performing a produce inspection of tomato greenhouses in June.
Prior to her deployment to LAO, Oliveira was a food specialist in the FDA Kansas City 

District Office (now Human and Animal Food West 2) where she worked on other food 

commodities in addition to many dietary supplement inspections, becoming one of their 

experts in this particular type of inspection.

Thus, it was fitting that she resumed inspections on May 24 by performing a high-priority 

compliance assignment of a dietary supplement firm. The next three inspections on 

Oliveira’s task list were produce inspections. With over 45% of the produce consumed 

in the United States coming from Mexico, these are high-priority inspections which will 

hopefully derail any potential outbreaks.

Because growing season ends in September, Oliveira’s work will take her all over the 

country of Mexico to inspect as many produce firms as she can. She created and 

implemented a COVID questionnaire in order to be as safe as possible and to gauge 

the COVID safety protocols of each facility before her visit. The document covers the 

wearing of masks and the number of staff who will be present during an inspection. It 

also helps assure the firms that she will be fully compliant with their own protocols.

One of the challenges a CSO faces in the field when performing produce inspections in remote areas is lack of an office set-up to 

review documents with management. During this inspection, Oliveira (first from right) reviewed documents on a round cement table 

and seats, where the harvesters usually eat their meals. The firm’s management called the set up “Janete’s rustic office!” Also, in 

this photo, a counterpart (first from the left) from the Mexican National Service of Agricultural Sanitation, Quality and Food Safety 

(SENASICA) observed the inspection as part of the FDA’s collaboration with this agency under the Food Safety Partnership (FSP) 

agreement signed by the two agencies in 2020.
Born in Brazil, Oliveira became fluent in Spanish during college, which is useful as she 

conducts produce inspections in Spanish. She says firms are grateful to be able to 

explain documents and processes, and answer questions in their native language. 

“During a regulatory inspection, I tend to pull up the Spanish version of the Produce 

Safety Rule on my computer and they appreciate that because they can understand it.”

Oliveira says that throughout her 12-year career with the FDA one thing that she really 

admires about foreign companies is their willingness to go above and beyond to reach 

compliance because they realize that an outcome of an inspection may affect their 

livelihood. Consequently, they take learning the rules seriously. “Part of my job is an 

educator. Everything that they can learn from me, to them, is a plus.”

Lunch break on the farm: Oliveira enjoying an authentic “pollo con mole” (chicken with mole sauce), flavored with spices and 

chocolate.

If there is time in between inspections, Oliveira says she will venture out and visit “some 

of the nicest places in Mexico where I never dreamed of going to before.” She loves to 

explore by eating authentic Mexican food, meeting different people, and absorbing the 
culture. “I really engage, and I really appreciate that side of my job very much,” she 

said.

Being flexible and adaptable is important for this type of work, and Oliveira will continue 

to support ORA with other high-priority assignments while maintaining her own 

workload. The value of her in-country inspectional support is immeasurable as the FDA 

continues the road to resiliency in its planning for both domestic and international 

inspections, with the goal of ensuring a safe food supply in the U.S.

Nelligan Breaks Down Formula for Success

When he isn’t championing the communications of OGPS’ Immediate Office, Health 

Communication Officer Jeff Nelligan is fascinating the world with his proudest dad 

moments. He has authored five books; one of which breaks down his formula for raising 

a resilient and driven cadre. He was recently featured in an NPR piece on Father’s Day.

Nelligan, a graduate of Williams College, is a U.S. Army Reserve/Army Guard veteran 

who worked many years on Capitol Hill and as a Schedule C appointee at the 

Department of State and at the Department of Health and Human Services. His drive 

and ambition come from his family. Nelligan’s lineage includes a long line of victors who 

overcame adversity to find prosperity.

The maternal side of his family are the tangata whenus, which means “people of the 

land” in Māori, an Austronesian language primarily spoken in the North Island in New 

Zealand. The Māori people are the indigenous Polynesian people of mainland New 

Zealand. Nelligan’s great-grandmother was Maori and left New Zealand when she was 
fourteen years old. He is a member of the Huria marae (family) in Tauranga; 

his Iwi (tribe) is Ngāti Ranginui.

After years in Utah and Idaho, where she was sometimes referred to as the “Black 

Devil” because of her skin color and ancestry, she settled in Los Angeles where she 

found success running and owning a popular restaurant. Nelligan’s grandmother, like 

her mother, was also an "overcomer." Although she was born nearly deaf, she became 

strong and confident, not allowing her deafness to become a hindrance. Indeed, she 

was an autodidact and became very well off financially playing rubber bridge. Nelligan’s 

mother, a political organizer, raised her three children with the cultural heritage passed 

down to her from previous generations.

The virtues of the Māori are clearly reflected in Nelligan’s three sons, and captured in 

the book, Four Lessons from My Three Sons. It provides simple and concise techniques 

proven to work. Here’s the proof:

His oldest son graduated from Williams College majoring in Mandarin. While there, he 

played four years of NCAA lacrosse; served as a Congressional staffer; and worked in 

Taipei in finance. He is currently a commissioned officer in the U.S. Navy with the 

U.S.S. Carl Vinson Carrier Strike Group in the Pacific.

Nelligan’s middle son graduated from the U.S. Naval Academy where he majored in 

math and played on the 2016 national champion U.S. Navy Club Lacrosse team. He is 

an engineering officer serving on a guided missile destroyer in the U.S. Navy, the 

U.S.S. Daniel Inouye, and is in the Pacific as well.

The youngest son is a senior cadet at the U.S. Military Academy at West Point, 

majoring in Arabic and French and will be commissioned an Infantry Officer. He is a 
member of the Army West Point men’s rugby team and was a congressional intern at 

the U.S. House of Representatives on the House Ways and Means committee.

While Nelligan’s narrative is light-hearted, his parenting approaches are solid and 

practical. His methods are doable. His formula unique. He says that being grounded in 

four areas will help boys “reflexively make the correct decision in every situation 

encountered at home and school, within their peer groups and the world at large.”

Resolute personal conduct

A confident worldview

Grinding resilience in adversity

Realistic ambition

The book also reveals the importance of identifying situations where parents can 

provide “practical and moral” on-the-spot instruction. Nelligan started seeking learning 

opportunities when his boys were very young. He then used these situations as 

subsequent examples of how they should behave when they were confronted with an 

identical or similar event. He framed these in an offbeat, funny manner. Later his sons 

referred to them as “sayings,” which resonate with them to this day.

The rest you’ll have to read for yourself.

FDA Issues Letter to Industry Following Issues with 

Sterility

The FDA issued a letter to medical device manufacturers on June 2, to alert them to 

sterility issues with medical devices processed at Steril Milano S.R.L.'s ethylene oxide 

sterilization facilities in Italy.

Claudia Louati is the lead for OGPS’ Europe Office, which is monitoring and supporting 

outreach to relevant European Union competent authorities related to Steril Milano, 

following reports of falsifications and fraud at the company’s ethylene oxide plants in 
Monza and Reggiolo. FDA is investigating the extent of the impact on firms and devices 

in the U.S. market.

The FDA has been working with medical device 

manufacturers, international partners, and U.S. federal 

partners to investigate the scope of medical devices that may 

be impacted since it became aware that Steril Milano had 

falsified graphs and parameters of sterilization certificates for 

a variety of FDA-regulated products, dating back to 2016.

The FDA believes that 97 medical device manufacturers may 

be affected including those that make biopsy needles, 

catheters, intravascular administration sets, arthroscopes, 

syringes, and other medical devices.

The Steril Milano S.R.L. Reggiolo and Monza ethylene oxide sterilization facilities were 

closed in March 2021 and are no longer sterilizing medical devices.

Europe Office Supports Collaborative Work to 

Combat Salmonella 

Europe Office (EO) Policy Advisor Alessandro Fiorelli is working closely with the Office 

of Regulatory Affairs (ORA) on a series of Salmonella international outbreaks linked to 

tahini as a source of contamination. Swedish authorities have recently notified 

the Epidemic Intelligence Information System (EPIS) network about the outbreak.

The FDA, together with the U.S. Centers for Disease 

Prevention (CDC), asked EO to reach out to the Swedish 

authorities following a suspected case identified in the United 

States, which is likely to be linked to the same outbreak.

Both the Swedish authorities (the Food Agency and the Public Health Authority of 

Sweden) and the FDA are interested in discussing findings and next steps to ensure the 

identification of firms that caused the Swedish outbreak, and that they are not exporting 

product to the U.S.
Beijing Embassy Recognizes CNO Staff

On June 3, the U.S. Embassy Beijing held their 2020 Mission Awards Ceremony, a 

celebration to recognize significant contributions to the U.S. Mission China. For the first 

time ever, locally employed staff and U.S. FDA direct hire staff (USDH) received 

recognition from the embassy for their achievements.

Members of OGPS’ China Office (CNO) received two Superior Honor Awards, which is 

presented to groups or individuals in recognition of a special act or service or sustained 

extraordinary performance covering a period of one year or longer. These awards are 

one of the highest awards presented at a Mission.

(L-R) Mandy Fu; Julia Wang; Vanessa Shaw-Dore; Nannan Zhang; Robert W. Forden, Chargé d’Affaires, a.i.; Emily Zheng; Latasha 

Robinson; Lixia Wang, M.D.; Nikki Sun. 

For exceptional teamwork and innovation to ensure safe, effective, and adequate 

supply of medical personal protective equipment in the United States during the 

COVID-19 pandemic.

Felix Marrero – Medical Devices Consumer Safety Officer

Rachel Gomez – Food Consumer Safety Officer

Qian Wang – Locally Employed Staff

Lixia Wang – Locally Employed Staff

Meisha Sampson – Medical Products Supervisory Consumer Safety Officer

Latasha Robinson – Deputy Country Director

Vanessa Shaw-Dore – Country Director
For extraordinary contributions and outstanding service in upholding the FDA’s 

public health mission during the China authorized departure of all FDA USDH 

staff.

Locally Employed Staff:

Zhe (Nikki) Sun

Huihan (Viki) Zhang

Hao (Emily) Zheng

Zimei (Mandy) Fu

Qian (Julia) Wang

Nannan Zhang

Lixia Wang, M.D.

Additional awards presented to FDA personnel included the Meritorious Honor Award, 

issued for a special act, or sustained outstanding performance; and the Franklin Award, 

issued for individual achievements of importance to the U.S. Mission. An example of 

some of these awards include FDA staff assisting in the implementation of the recent 

US-China Phase 1 Trade Agreement, as well as continued safe and effective 

importation of medical products and foods. “The CNO was honored to be recognized for 

our contributions,” said CNO Deputy Director Latasha Robinson.

CNO Staff Resumes Live Engagement

Although the pandemic continues to make travel within mainland China a challenge, 

staff in the OGPS China Office (CNO) have still managed to continue their outreach and 

engagement efforts with Chinese regulators and industry, traveling to various cities 

throughout China to participate in speaking engagements covering regulatory topics 

related to drugs, medical devices, and dietary supplements.

Deputy Country Director Latasha Robinson supported Mission China’s Foreign 

Commercial Service (FCS), by participating in the 2021 Natural Health & Nutrition 

Expo (NHNE) and USA Day in Shanghai, China. Robinson told companies considering 

exporting their dietary supplements to the U.S. that they must adhere to the same rules 

as U.S. manufacturers do, which are intended to ensure the safety of dietary ingredients 

and dietary supplements. These rules include Preventive Controls under the Food 
Safety and Modernization Act and Current Good Manufacturing Practice in the 

Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.

Deputy Director Latasha Robinson (at the lectern) addresses the audience 

Medical Device International Relations Specialist Scott Gonzalez participated in the 

13th Annual China Medical Device International Regulators Forum in Shanghai, 

organized by the Chinese Association for Medical Device Industry. Gonzalez presented 

updates on FDA medical device regulatory policy, including negotiations to reauthorize 

the Medical Device User Fee Amendments, novel premarket pathways to market, and 

the FDA’s new Digital Health Center of Excellence, which was established in September 

2020. The center is dedicated to the advancement of digital health technology, including 

mobile health devices, Software as a Medical Device (SaMD), wearables when used as 

a medical device, and technologies used to study medical products.
Medical Device International Relations Specialist Scott Gonzalez presenting updates

Country Director Shaw-Dore gave remarks at the opening plenary of the DIA China 

2021 Annual Meeting that focused on FDA initiatives to strengthen regulatory science. 

Medical product supervisor Jonathan Chapman also attended the meeting to talk 

about Pre-Approval and Pre-License Inspections. 

Country Director Vanessa Shaw-Dore and Julia Wang pictured with individuals at Yeehong University
Chapman also attended the Biologics Manufacturing & Quality Management Forum 

along with Program Coordinator for Medical Product Program Julia Wang and 

discussed the FDA’s expectations for sterile drug manufacturing. The event was 

organized by China Pharmaceutical Association of Plant Engineering.

Jonathan Chapman speaking at the lectern

Roy Stephens has been selected as the China Office’s 

(CNO) Human and Animal Food Supervisory Consumer 

Safety Officer, replacing Jennifer Mathern, effective the week 

of July 5. He has been with the FDA for greater than 

nineteen years, mostly in Cincinnati, Ohio, serving in the 

consumer safety officer and supervisory consumer safety 

officer roles.
His background includes human food, animal feed, medical devices, drug, bioresearch 

monitoring, and import work, with actions resulting in seizures, injunctions, and 

prosecution. For the past two years, Stephens has been a food and feed consumer 

safety officer in the FDA China Office with recent results involving fraud detection and 

data integrity. In his new position, he looks forward to future interactions with 

government entities and the resulting opportunities to build coordination for food safety.

CDR Nicole Conklin has transitioned from the Latin America 

Office to the Policy Team (PPT) of OGPS' Office of Global 

Operations as an international policy analyst for the foods 

portfolio. She was previously an international relations 

specialist in San José, Costa Rica, where she was 

responsible for overseeing regional implementation efforts 

for the Food Safety Modernization Act.

She has collaborated with a variety of partners to design and conduct capacity 

development initiatives to enhance Produce Safety Rule training and information 

availability for Latin American growers, governments, and industry. As a result, over 

4,000 growers received training. 

CDR Conklin joined the FDA in 2013, as a consumer safety officer in ORA’s Kansas 

City District conducting food manufacturing inspections and investigations. She was 

commissioned as an ensign in the U.S. Public Health Service while still a nursing 

student and served her first eight years as a clinical nurse with the Indian Health 

Service on the Winnebago Reservation in Nebraska.

CDR Conklin earned her Bachelor of Science in Nursing from Johns Hopkins University 

School of Nursing and is close to completing her Master of Public Health, Administration 

and Policy, from the University of Minnesota, Twin Cities.

The Dear International Colleague Letter (DICL) is a letter sent via email to a list-serve of 

about 20,000 subscribers – both D.C.-based embassies and international stakeholders. 
The DICL is intended to inform these stakeholders of any FDA announcements that are 

relevant to an audience with international interests. Here are the most recent DICLs: 

FDA Marks World Food Safety Day 2021

Executive Order 14017 on America’s Supply Chains

Regulatory Education for Industry (REdI) Annual Conference 2021

Upcoming events 

July 6 20th Anniversary of COFEPRIS

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