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FDA announced the fiscal year 2024 OTC-Monograph Drug User Fee rates in the Federal Register Vol 89, No. 62 published 29 March 2024. These fees cover FDA’s FY2024 which runs from October 2023 through September 2024.  The facility fees for FY 2024 are due on 3 June 2024.

Regarding fee specifics,

  • Owners of manufacturing and processing facilities of finished OTC-drug dosage forms will pay a full facility fee: $34,166
  • Owners of a contract manufacturing facility will pay 2/3 of the full fee: $22,777
  • Submitters of OTC monograph order requests (OMOR) will pay tier-based user fees, (with the exception of those submitting certain safety-related changes). Tier 1 OMOR user fees are assessed at $537,471, Tier 2 OMOR user fees are assessed at $107,494

The facility fees are assessed on any facility that identified the business process of OTC monograph drug facility in their establishment registration during the fee-liable period of 1 January 2023 through 31 December 2023.  Comments may be made to Docket Number FDA-2023-N-3575-0001for the reauthorization of OMUFA.

Under GDUFA, human generic drug facilities, sites, and organizations are required to submit identification information electronically to FDA annually.  These submissions are made during the month of May.

The following types of generic industry facilities, sites, and organizations are required to self-identify with FDA:

  1. Facilities that manufacture, or intend to manufacture, human generic drug APIs or FDFs, or both.
  2. Facilities that package the FDF of a human generic drug into the primary container/closure system and label the primary container/closure system.
  3. Sites that are identified in a generic drug submission and pursuant to a contract with the applicant remove the drug from a primary container/closure system and subdivide the contents into a different primary container/closure system.
  4. Bioequivalence (BE)/bioavailability (BA) sites that are identified in a generic drug submission and conduct clinical BE/BA testing, bioanalytical testing of samples collected from clinical BE/BA testing, and/or in vitro BE testing.
  5. Sites that are identified in a generic drug submission and perform testing of one or more attributes or characteristics of the FDF or the API pursuant to a contract with the applicant to satisfy a current good manufacturing practice (CGMP) testing requirement (excludes sites that are testing for research purposes only).

FDA recently issued Warning letters under the subject ‘Failure to Register and List’.  Per one of the warning letters: Drug listing submissions must include the name and Unique Facility Identifier of the establishment where the registrant who lists the drug manufactures it and the type of operation performed on the drug at that establishment as required. Furthermore, the listing file must include the name and Unique Facility Identifier of every other establishment where manufacturing is performed for the drug and the type of operation performed at each such establishment. All drug listings should identify all facilities involved in the manufacture / process of the drug in their SPL file.  Examples of facilities to include in addition to the manufacturer are: API manufacturer, contract analysis, contract packing, or contract labeling if applicable.  With June just around the corner, registrants should be reviewing all SPL information for completeness and plan to submit updates as needed.

Highlighted Guidance Documents

Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry


Submit Comments by 06/25/2024

Data Integrity for In Vivo Bioavailability and Bioequivalence Studies


Submit Comments by 07/03/2024

Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry

This guidance provides instructions for the electronic submission of expedited individual case safety reports from investigational new drug exempt bioavailability/bioequivalence studies conducted to support abbreviated new drug applications to FDA Adverse Event Reporting System. An ICSR captures information necessary to support the reporting of an adverse event related to an individual subject that is associated with the use of an FDA-regulated product. The electronic submission of the ICSRs from IND-exempt BA/BE studies is a voluntary option for submitting these required reports.

Providing Regulatory Submissions in Electronic Format: IND Safety Reports Guidance for Industry

FDA is announcing the availability of a final guidance for industry entitled “Providing Regulatory Submissions in Electronic Format:  IND Safety Reports.”  This guidance finalizes the draft guidance of the same name published on October 30, 2019, and describes the electronic format sponsors will be required to use when they electronically submit IND safety reports to CDER and CBER for serious and unexpected suspected adverse reactions, as required.

Data Standards Catalog

All Guidance Documents can be searched on the FDA’s website.

Federal Register

Federal Register Vol 89, No. 62 Over-the-Counter Monograph Drug User Fee Program-Facility Fee Rates for Fiscal Year 2024


Clinical Pharmacology Guidances Advancing Drug Development and Regulatory Assessment | Role and Opportunities
Date:  May 8 – 9, 2024
Day1:  Wed, May 8 9:00 AM – 2:30 PM ET
Day2:  Thu, May 9 9:00 AM – 2:30 PM ET

Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval
Date:  May 9, 2024
Time:  1:00 PM – 3:30 PM ET

Statistical Considerations for Premarketing Risk Assessment
Date:  May 16, 2024
Time:  1:00 PM – 2:30 PM ET

Fiscal Year 2024 Generic Drug Science and Research Initiatives Public Workshop
Date:  May 20 – 21, 2024
Day1:  Mon, May 20 8:00 AM – 4:30 PM ET
Day2:  Tue, May 21 9:00 AM – 2:30 PM ET

Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development
Date:  May 29 – 30, 2024
Day1: Wed, May 29 8:30 AM – 4:30 PM ET
Day2: Thu, May 30 8:30 AM – 4:30 PM ET

FDA’s Fifth Online Controlled Substances Summit
Date:  July 25 – 26, 2024
Day1:  Thu, Jul 25 11:00 AM – 3:00 PM ET
Day2:  Fri, Jul 26 11:00 AM – 4:00 PM ET

FDA Websites of Interest

Posted in Drug and Device Corner, Drugs, Medical Devices.