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  4. Reporting Drug Amount Under Section 510(j)(3) of the FD&C Act - 09/08/2022
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Virtual | Virtual

Event Title
Reporting Drug Amount Under Section 510(j)(3) of the FD&C Act
September 8, 2022

Date:
September 8, 2022
Time:
9:30 AM - 3:30 PM ET

 

Topics & Presentations

Speakers

Reporting Drug Amount Under Section 510(j)(3) of the FD&C Act - Opening Remarks and Session 1

 

Opening Remarks (PDF - 222 KB)

Jennifer Forde
Regulatory Counsel  
Office of Regulatory Policy (ORP)
Center for Drug Evaluation and Research (CDER) | FDA

Drug Amount Reporting Regulatory Background (PDF - 222 KB)

Jennifer Forde
Regulatory Counsel
Office of Regulatory Policy (ORP)
Center for Drug Evaluation and Research (CDER) | FDA

Registration and Listing Regulatory Background and Requirements (PDF - 223 KB)

Leyla Rahjou-Esfandiary
Lead Consumer Safety Officer 
Office of Compliance (OC)
Center for Drug Evaluation and Research (CDER) | FDA 

Purpose of Drug Amount Reporting (PDF - 1 MB)

Matthew Rosenberg
Economist
Office of Strategic Programs (OSP)
Center for Drug Evaluation and Research (CDER) | FDA

Basic Framework for Reporting (PDF - 223 KB)

Jennifer Highland
Operations Research Analyst
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER) | FDA 

Question & Answer Panel

Jennifer Forde, Leyla Rahjou-Esfandiary, Matthew Rosenberg, and Jennifer Highland

Reporting Drug Amount Under Section 510(j)(3) of the FD&C Act - Session 2

 

CARES Drug Amount Report Examples (PDF - 310 KB)

 

Further Details on using CSV Files (PDF - 393 KB)

Obinna Ugwu-Oju
Division Director
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER) | FDA 

Edward Hallissey
Project Management Officer
Office of Strategic Programs (OSP)
Center for Drug Evaluation and Research (CDER) | FDA 

Question & Answer Panel

Obinna Ugwu-Oju
Division Director
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER) | FDA 

Edward Hallissey
Project Management Officer 
Office of Strategic Programs (OSP)
Center for Drug Evaluation and Research (CDER) | FDA 

Daniil Graborov
Computer Scientist
Office of Business Informatics (OBI)
Center for Drug Evaluation and Research (CDER) | FDA

Reporting Drug Amount Under Section 510(j)(3) of the FD&C Act – Session 3 and Closing Remarks

 

CARES Act OTC Drug Volume Reporting – Perrigo (PDF - 1 MB)

Kim Armstrong
Associate Director
Perrigo OTC Regulatory Affairs Operations

Johnson & Johnson Consumer Inc. - CARES Act Drug Amount Reporting – OTC Products (PDF - 351 KB)

Gracy Tirado
Associate Director RA Compliance
Johnson & Johnson Consumer Inc.

Reporting Drug Amounts Under Section 510 of the FD&C Act as an Authorized Agent and cGMP Consultant (PDF - 493 KB)

Ken Coleman ("KC") Stevenson II
VP of Regulatory
Ceutical Laboratories, Inc.

Drug Volume Reporting: Industry Perspective (PDF - 419 KB)

Ben Harpster
QA Compliance Manager
GlaxoSmithKline

Question & Answer Panel

Jennifer Forde
Regulatory Counsel
Office of Regulatory Policy (ORP)
Center for Drug Evaluation and Research (CDER) | FDA 

Jennifer Highland
Operations Research Analyst
Office of Pharmaceutical Quality (OPQ) 
Center for Drug Evaluation and Research (CDER) | FDA 

Obinna Ugwu-Oju
Division Director
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER) | FDA 

Edward Hallissey
Project Management Officer
Office of Strategic Programs (OSP)
Center for Drug Evaluation and Research (CDER) | FDA 

Daniil Graborov
Computer Scientist
Office of Business Informatics (OBI)
Center for Drug Evaluation and Research (CDER) | FDA 

Closing Remarks

Jennifer Forde
Regulatory Counsel
Office of Regulatory Policy (ORP)
Center for Drug Evaluation and Research (CDER) | FDA

 

Agenda

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ABOUT THIS CONFERENCE

In 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) amended the FD&C Act to require that each person (including repackers and labelers) who registers with FDA under section 510 of the FD&C Act with regard to a human or animal drug must report annually to FDA the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution.

In this webinar, FDA will provide an overview of the drug amount reporting program, including discussions of how FDA uses the drug amount report data and who reports and how (with examples and demonstrations). FDA will also provide a discussion of registration and listing requirements, and how they pertain to the drug amount reporting program. The event will also include industry presenters, who will provide feedback regarding the drug amount reporting program. Conference participants will also have an opportunity to ask questions during question-and-answer sessions.

TOPICS COVERED:

  • Scope and purpose of drug amount reporting
  • Connection between drug registration and listing requirements and section 510(j)(3) reports (including with respect to contract manufacturer reporting)
  • Who in the supply chain is required to submit section 510(j)(3) reports
  • Recommendations for how to report drug amount data, including for:
    • non-US manufactured drugs
    • private label distributed drugs
    • multi-level packaged drugs
    • applicant submitting report on behalf of a registrant
  • Scenarios presented by industry regarding the drug amount reporting program

 

INTENDED AUDIENCE

Registrants (including contract manufacturer registrants) of listed drugs, including a finished dosage form product, an active pharmaceutical ingredient (API), and other types of listed drugs. The types of listed drugs also include medical gases, homeopathic products, over-the-counter drugs, and animal drugs.

FDA RESOURCES

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