Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                FDA Meetings, Conferences and Workshops

FDA Meetings, Conferences and Workshops

                        FDA Meetings, Conferences, and Workshops: Past Events
          FDA Annual Reports on Conferences


                        Public Calendar - Meetings With FDA Officials Home
          News & Events
          FDA Meetings, Conferences and Workshops
          2022 FDA-Held Conferences With Expenses Over $100,000FDA Meetings, Conferences and Workshops 2022 FDA-Held Conferences With Expenses Over $100,000
  
  	
    Share
    Post
    Linkedin

    Email
    PrintGeneral Report

The Food and Drug Administration (FDA) hosted, sponsored, and/or co-sponsored 5 conferences with expenditures greater than $100,000 this fiscal year. The FDA funded the conference, travel, and/or other expenses for 6,784 FDA attendees, 6,140 Federal employees and 644 Non-Federal employees. There were no other conference sponsors outside of FDA.  However, conference topics included, but were not limited to: issues related to outsourcing facilities and drug production as well as educated the sector on relevant policy matters and FDA oversight approaches; FDA's regulatory requirements to legally study and market drugs, medical devices, and biologics in the United States; FDA's regulatory requirements as related to these stakeholders with a proposed emphasis on strengthening global regulatory capacity for the review of new priority medicines for treatment of TB; FDA's regulatory requirements on a specific aspect of the drug development continuum (for example, Pharmaceutical Quality); and to communicate to the generic industry how FDA research outcomes guide and facilitate complex generic drug product development. All conferences funded and attended followed the applicable Federal authorities, policies, and procedures. Furthermore, all conferences helped advance the FDA’s mission.  For instance, some of these conferences allowed FDA to hear directly from small business owners about their questions/concerns about the FDA regulatory procedures. These forums also allowed FDA to share targeted regulatory information to attendees, and in turn, this assisted in sponsors submitting more complete application to the FDA, which should ultimately reduce the review time.

Narrative Report

See below for a summation of all conference expenditures for FY 2022.
Total Conference Net Expenses (in dollars)    $825,574.72

Conference Report

**CONF - 03737
Basic Information**

Conference Title     **FDA22 Center of Excellence on Compounding for Outsourcing Facilities 2022**
Applicable Conference Type    Scientific, FDA Hosted/Sponsored/Co-Sponsored

Conference Location    Virtual
Conference Start Date    09/13/2022
Conference End Date     09/14/2022

**Cost and Attendee Information**

Total agency cost of the conference      $376,249.00

Total number of individuals whose travel expenses were paid by the agency    0

**Explanation of how the conference advanced the mission of the agency**

This was a two-day year-end conference for outsourcing facilities that engaged the sector on issues related to outsourcing facilities and drug production as well as educated the sector on relevant policy matters and FDA oversight approaches. Content topics included key and recent policies related to compounding issued by FDA; CGMP for outsourcing facilities; process design and use of automation technology by outsourcing facilities; FDA inspectional process for outsourcing facilities; interactions with FDA during and after inspections, including responses to FDA Form 483s and warning letters, and pre-operational meetings with FDA. Details gathered from training sessions and interviews with outsourcing facilities, state regulators and other stakeholders were used to solidify the conference agenda and format.

**CONF - 03862
Basic Information**

Conference Title     **FDA22 Small Business Regulatory Education for Industry Annual Conference**
Applicable Conference Type    Scientific, FDA Hosted/Sponsored/Co-Sponsored

Conference Location    Virtual
Conference Start Date    06/06/2022
Conference End Date     06/10/2022

**Cost and Attendee Information**

Total agency cost of the conference      $131,243.43

Total number of individuals whose travel expenses were paid by the agency    0

**Explanation of how the conference advanced the mission of the agency**

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance’s (SBIA’s) mission is to promote productive interaction by assisting regulated domestic and international small pharmaceutical business and industry seeking timely and accurate information relating to development and regulation of human drug products. SBIA outreach activities include hosting events in locations that have been determined to be geographically dense with small pharmaceutical businesses, including the generic and device industries. CDER SBIA helps empower small businesses in their interactions with FDA and aids those businesses in the development of more complete submissions and first-cycle drug approvals. FDA employees participated at REdI to present on FDA's regulatory requirements to legally study and market drugs, medical devices, and biologics in the United States. The events described in the Statement of Work (SOW) are designed for one-on-one interaction and will also offer a virtual on-line format to promote the accessibility of valuable knowledge and expand the number of global attendees. SBIA events target small pharmaceutical/devices/biologics business and are in fact widely attended by all levels of industry including small, medium, and large pharma. This meeting was a major program element for the CDER Small Business and Industry Assistance (CDER SBIA) program within the Division of Drug Information (DDI) in the CDER Office of Communications (OCOMM). This meeting allowed FDA to hear directly from small business owners about their questions/concerns about the FDA regulatory procedures. This forum allowed FDA to share targeted regulatory information to attendees. This in turn will assist sponsors submitting more complete application to the FDA, which should ultimately reduce the review time.

**CONF - 03738
Basic Information**

Conference Title     **FDA22 Small Business Regulatory Education for Industry Prescription Drug Labeling Forum**
Applicable Conference Type    Scientific, FDA Hosted/Sponsored/Co-Sponsored

Conference Location    Virtual
Conference Start Date    08/17/2022
Conference End Date     08/18/2022

**Cost and Attendee Information**

Total agency cost of the conference      $106,027.43

Total number of individuals whose travel expenses were paid by the agency    0

**Explanation of how the conference advanced the mission of the agency**

FDA employees collaborated with the National Institutes of Health (NIH), Unites States Pharmacopoeia (USP), and others to present on FDA's regulatory requirements as related to these stakeholders with a proposed emphasis on strengthening global regulatory capacity for the review of new priority medicines for treatment of TB. This meeting was an inroad for the CDER Small Business and Industry Assistance (CDER SBIA) program within the Division of Drug Information (DDI) in the CDER Office of Communications (OCOMM) in that it ushered in a new collaboration with NIH and USP. CDER Small Business and Industry Assistance’s (SBIA’s) mission is to promote productive interaction by assisting regulated domestic and international small pharmaceutical business and industry seeking timely and accurate information relating to development and regulation of human drug products. SBIA outreach activities include hosting events in locations that have been determined to be geographically dense with small pharmaceutical businesses, including the generic and device industries. CDER SBIA helps empower small businesses in their interactions with FDA and aids those businesses in the development of more complete submissions and first-cycle drug approvals. This meeting allowed FDA to hear directly from manufacturers and regulators. This forum allowed FDA to share targeted regulatory information to attendees. This in turn assisted in sponsors submitting more complete application to the FDA, which should ultimately reduce the review time. SBIA events target small pharmaceutical/devices/biologics business and are widely attended by all levels of industry including small, medium, and large pharma.

**CONF - 02874
Basic Information**

Conference Title     **FDA22 Small Business Regulatory Education for Industry Pharmaceutical Quality Symposium**
Applicable Conference Type    Scientific, FDA Hosted/Sponsored/Co-Sponsored

Conference Location    Virtual
Conference Start Date    10/01/2021
Conference End Date     10/02/2021

**Cost and Attendee Information**

Total agency cost of the conference      $106,027.43

Total number of individuals whose travel expenses were paid by the agency    0

**Explanation of how the conference advanced the mission of the agency**

At this conference, FDA employees presented on FDA's regulatory requirements on a specific aspect of the drug development continuum: e:g Pharmaceutical Quality. This meeting was a major program element for the CDER Small Business and Industry Assistance (CDER SBIA) program within the Division of Drug Information (DDI) in the CDER Office of Communications (OCOMM). This meeting allowed FDA to hear directly from small business owners about their questions/concerns about the FDA regulatory procedures. This forum allowed FDA to share targeted regulatory information to attendees, and this in turn assisted in sponsors submitting more complete application to the FDA, which should ultimately reduce the review time.

**CONF - 02871
Basic Information**

Conference Title     **FDA22 Small Business Regulatory Education for Industry Innovative Generic Drug Development Forum**
Applicable Conference Type    Scientific, FDA Hosted/Sponsored/Co-Sponsored

Conference Location    Virtual
Conference Start Date    09/21/2022
Conference End Date     09/22/2022

**Cost and Attendee Information**

Total agency cost of the conference      $106,027.43

Total number of individuals whose travel expenses were paid by the agency    0

**Explanation of how the conference advanced the mission of the agency**

The purpose of this science-focused workshop was to communicate to the generic industry how FDA research outcomes guide and facilitate complex generic drug product development. FDA linked GDUFA science and research on complex drug products to product-specific guidance development, discussed pre-ANDA meetings and review, and examined various areas of complex product science. This meeting was a major program element for the CDER Small Business and Industry Assistance (CDER SBIA) program within the Division of Drug Information (DDI) in the CDER Office of Communications (OCOMM). This meeting allowed FDA to hear directly from small business owners about their questions/concerns about the FDA regulatory procedures. This forum also allowed FDA to share targeted regulatory information to attendees, and this in turn assisted in sponsors submitting more complete application to the FDA, which should ultimately reduce the review time.

**NOTE:** For conferences with expenses more than $500,000, in addition to the information required above, the agency approving official will note the expense of the conference is the cost-effective to achieving a compelling purpose and the basis for such approval must be documented in writing by the designated approving official.

Supplemental Information

**Reference Authority**

21st Century Cures Act, Public Law 114-255, December 2016
	(https://www.congress.gov/bill/114th-congress/house-bill/34/text)
	OMB Memorandum M-17-08, Promoting Efficient Spending to Support Agency Operations, Section 2, November 2016
	(https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/memoranda/2017/m-17-08.pdf)
	HHS Policy on Promoting Efficient Spending: Use of Appropriated Funds for Conferences and Meeting Space, Food, Promotional Items, and Printing and Publications, September 2017
	(https://www.hhs.gov/grants/contracts/contract-policies-regulations/efficient-spending/index.html)**Note: This link leads to the 2015 version of the policy that is currently listed on the HHS.gov website. Once the 2017 version of the policy has been uploaded to the HHS.gov website, this link must be updated to reflect the 2017 policy.**
	FDA Conference Approval and Public Reporting (CAPR) Staff Manual Guide (SMG) 2350.5**Recipient:** Assistant Secretary of Financial Resources (ASFR)**Frequency/Submission Date:**Annually/ January 31st of each year**Distribution:**Published to FDA Annual Report on Conference website

                                                                                  Content current as of:
      01/30/2023FDA Meetings, Conferences and Workshops

          
                        FDA Meetings, Conferences, and Workshops: Past Events
          FDA Annual Reports on Conferences


                        Public Calendar - Meetings With FDA Officials
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop