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The FDA has issued a final Guidance Document to assist drug establishment registrants with understanding the CARES Act reporting requirements. Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act guidance offers very detailed instructions for submitting volume information. The agency also sheds light on the need for these reports.

The CARES Act passed on 27 March 2020, requires each drug establishment registrant to report annual amounts of drugs that were manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S. The term ‘commercial distribution’ is defined in 21 CFR 207.1. The FDA previously noted that this data is expected to assist the agency in mitigation of drug shortages by providing a better understanding of the existing drug supply chain for the U.S. The guidance explains that additionally, the agency will use this data in decision making with regard to drug facility surveillance. It is important to note, the agency considers CARES report data confidential commercial information (CCI) and not disclosable in response to an FOI.

Every drug establishment registered with the FDA must report their volumes to the agency per NDC. In the case of a contract manufacturer of human drugs, the CMO’s assigned NDC and the Private Label Distributor’s NDC should be reported individually. For animal drugs manufactured by a contract facility, only the PLD NDC should be reported. The report is broken down by month, the release date of the drug should be used to determine in which month to report. Returned or recalled amounts of drugs should NOT be factored into the report, all released volumes should be submitted.

2023 reports are due no later than 1 July 2024. See the guidance document for full details.

The Food and Drug Administration issued a final rule on January 31, 2024, to amend the medical device current good manufacturing practice requirements of the Quality System regulation defined in 21 CFR Part 820 to harmonize and modernize the regulation. The reason for the change is to align more closely with the international consensus standard for devices, ISO 13485, 2016 edition, by converging with the quality management system requirements used by other regulatory authorities from other jurisdictions (i.e., other countries). This will be accomplished by incorporating reference to the quality management system requirements of ISO 13485, an international standard specific for device quality management systems. Through this rulemaking the FDA will also establish additional requirements and make conforming edits to clarify the device CGMP requirements for such products. The title of the regulation will also be amended as the Quality Management System Regulation (QMSR). The effective date for enforcement is February 6, 2026. These edits do not impact the CGMP requirements for combination products. You can read the announcement in the Federal Register Vol. 89, No. 23. Comments that were submitted to this proposed rule can be reviewed at Docket number FDA-2021-N-0507-0001.

The FDA issued an email to inform ANDA holders that electronic verification and submission of approved ANDAs and affiliates is available through CDER Direct NextGen Collaboration Portal for fiscal year (FY) 2025. The reminder included details for those wishing to either withdraw or transfer ownership of an approved ANDA prior to the user fee assessment period for FY2025. If you need further details contact EAS.

Highlighted Guidance Documents

DRAFT Guidance Conducting Remote Regulatory Assessments Questions and Answers

The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled “Conducting Remote Regulatory Assessments–Question and Answers.” FDA is issuing the draft guidance to describe the Agency’s current thinking regarding its use of remote regulatory assessments in order to increase industry’s understanding of RRAs and facilitate FDA’s process for conducting RRAs. This draft guidance provides answers to frequently asked questions regarding what RRAs are, when and why FDA may use them, and how FDA may conduct them, among others.

Comments may be submitted to Docket number: FDA-2022-D-0810.

DRAFT Guidance Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act

The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled “Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act.” The draft guidance is intended to assist applicants and manufacturers in providing FDA timely, informative notifications about changes in the production of certain finished drugs and biological products as well as certain active pharmaceutical ingredients that may, in turn, help the Agency in its efforts to prevent or mitigate shortages. The draft guidance also explains how FDA communicates information about products in shortage to the public.

Submit comments to Docket number FDA-2020-D-1057

Charging for Investigational Drugs Under an IND: Questions and Answers

This guidance addresses frequently asked questions related to the implementation of FDA’s regulation on charging for investigational drugs under an investigational new drug application for the purpose of either clinical trials or expanded access for treatment use. This guidance finalizes the revised draft guidance of the same title issued on August 23, 2022, and replaces the final guidance issued on June 3, 2016.

CVM GFI #188 Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine

The purpose of this guidance is to assist applicants and nonapplicants with filling out Form FDA 1932, “Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report.” As required by Food and Drug Administration regulations at 21 CFR 514.80, an applicant must report adverse drug experiences and product/manufacturing defects on Form FDA 1932. Firms named on the label as a manufacturer, packer, or distributor may also use this form.

DRAFT Guidance Advanced Manufacturing Technologies Designation Program

This draft guidance provides recommendations to persons and organizations interested in participating in FDA’s Advanced Manufacturing Technologies Designation Program, which is intended to facilitate the development of drugs, including biological products, manufactured using an AMT that has been designated as such under the program.

Submit Comments by 03/13/2024

DRAFT Guidance Use of Data Monitoring Committees in Clinical Trials

This guidance is intended to assist sponsors of clinical trials in determining when a data monitoring committee, or an independent data monitoring committee would be useful for trial monitoring and what procedures and practices should be considered to guide their operation. When finalized, this guidance will supersede the final guidance for clinical trial sponsors entitled “Establishment and Operation of Clinical Trial Data Monitoring Committees,” issued in March 2006. This draft guidance is not final nor is it in effect at this time.

Submit Comments by 04/15/2024

DRAFT Guidance Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance

FDA has developed this draft guidance to propose select updates to the FDA guidance document Medical Device User Fee Small Business Qualification and Certification. This guidance provides additional information for the granting of the small business registration fee waiver. The existing guidance on small business user fees remains in effect, in its current form, until this draft guidance is finalized. FDA is seeking feedback on revisions proposed in this select update.

Submit Comments by 04/22/2024

DRAFT Guidance Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products

The purpose of this guidance is to provide FDA’s expectations for, and recommendations on, use of a standardized approach for collecting and reporting race and ethnicity data in submissions including information collected and reported from clinical studies and clinical trials for FDA-regulated medical products. Using standard terminology for race and ethnicity helps ensure that data are collected and reported consistently in submissions to FDA. This draft guidance revises the final guidance for industry and FDA staff entitled “Collection of Race and Ethnicity Data in Clinical Trials” issued on October 26, 2016.

Submit Comments by 4/29/2024

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


Federal Register

Federal Register Vol. 89, No. 29 Biologics License Applications and Master Files


Integrated Safety Analyses in Drug Marketing Applications: Avoiding Common Mistakes

Date: March 7, 2024
Time: 1:00 PM – 2:30 PM ET

Enhancing Adoption of Innovative Clinical Trial Approaches

The Duke-Margolis Institute for Health Policy, under a cooperative agreement with the U.S. Food and Drug Administration, is convening a two-day hybrid Public Workshop

Date: March 19-20, 2024
Day 1: Tue, Mar 19, 2024 10:00 AM
Day 2: Wed, Mar 20, 2024 12:30 PM

Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access

Date: April 10 – 11, 2024
Day1: Wed, Apr 10 8:30 AM – 5:00 PM ET
Day2: Thu, Apr 11 8:30 AM – 5:00 PM ET

Considerations and Potential Regulatory Applications for Model Master File

FDA/CRCG Workshop
Date:  May 2 – 3, 2024
Day 1: Thur, May 2 8:30am – 3:50pm EDT
Day 2: Fri, May 3, 8:30 am – 3:50 pm EDT

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

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