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Drug and Device March 2024

Mar 28, 2024 | Drug and Device Corner, Drugs, Medical Devices

Drug and Device

Reminder that CARES volume 2023 reports are due no later than 1 July 2024.

Highlighted Guidance Documents

Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide

FDA is issuing this Technical Conformance Guide to assist registrants of drug establishments in submitting reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act, as added by section 3112(e) of the Coronavirus Aid, Relief, and Economic Security Act. This guide supplements the draft guidance for industry Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act. The guide describes 1) how first-time users can access FDA’s CDER NextGen Portal to submit these reports, 2) the different methods for submitting the reports through the portal, and 3) the data elements to be included in the reports.

Controlled Correspondence Related to Generic Drug Development

This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit controlled correspondence to FDA requesting information related to generic drug development and the Agency’s process for providing communications related to such correspondence. This guidance finalizes the draft guidance of the same title issued on December 22, 2022.  This guidance replaces the guidance “Controlled Correspondence Related to Generic Drug Development” issued on December 17, 2020.

Q14 Analytical Procedure Development

The FDA is announcing the availability of final guidance for industry entitled “Q14 Analytical Procedure Development.”  This guidance was prepared under the auspices of ICH.  The guidance provides harmonized guidance on scientific approaches for analytical procedure development and describes principles to facilitate more efficient, science-based, and risk-based postapproval change management.

Q2(R2) Validation of Analytical Procedures

The FDA is announcing the availability of final guidance for industry entitled “Q2(R2) Validation of Analytical Procedures”.  The guidance was prepared under the auspices of ICH.  This guidance provides a general framework for the principles of analytical procedure validation, including validation principles that cover the analytical use of spectroscopic data.

DRAFT GUIDANCES available for comment

Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards
DRAFT GUIDANCE
Submit Comments by 04/30/2024

Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products
DRAFT GUIDANCE
Submit Comments by 05/13/2024

Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act
DRAFT GUIDANCE
Submit Comments by 05/13/2024

Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program – Draft Guidance for Industry and Food and Drug Administration Staff
DRAFT GUIDANCE
Submit Comments by 05/14/2024

CVM GFI #285 – Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs
DRAFT GUIDANCE
Submit Comments by 05/17/2024 

Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples
DRAFT GUIDANCE
Submit Comments by 05/28/2024

Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products
DRAFT GUIDANCE
Submit Comments by 06/20/2024

E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports
DRAFT GUIDANCE
Submit comments to Docket ID FDA-2024-D-0803

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

Federal Register

Federal Register Vol 89, No. 45 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Food and Drug Administration Approval to Market a New Drug

Comments may be made to Docket ID FDA-2020-N-2030 by 5 April 2024

Federal Register Vol 89, No. 49 Labeling Requirements for Approved or Conditionally Approved New Animal Drugs

FR Vol 89, No. 53, Manufacture of Batches in Support of Original New Animal Drug Applications, Abbreviated New Animal Drug Applications, and Conditional New Animal Drug Applications; Draft Guidance for Industry; Availability

FR Vol 89, No. 55, Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act

Meetings

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

Facilitating Generic Drug Product Development through Product-Specific Guidances
Date:  April 25, 2024
Time: 1:00 PM – 4:00 PM ET

Considerations and Potential Regulatory Applications for a Model Master File
Date:  May 2 – 3, 2024
Day 1: May 2 , 8:30 am  –  5:35 pm
Day 2: May 3 , 8:30 am  –  3:50 pm
Co-hosts: FDA and the Center for Research on Complex Generics (CRCG)

Natural History Studies and Registries in the Development of Rare Disease Treatments
Date:  May 13, 2024
Time: 10:00 AM – 3:30 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

FDA Websites of Interest

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