With the requirement for Cosmetic Responsible Persons to report Serious Adverse Events to FDA beginning 29 December 2023, the agency has recommended using the current Form 3500A that is downloadable and fillable at MedWatch: The FDA Safety Information and Adverse Event Reporting Program – Mandatory. The website How to Report a Cosmetic Related Complaint has a link and further details. Additionally, the website FDA Issues Updated Instructions for Serious Adverse Event Reporting for Cosmetic Products has instructions on the requirements.
An OMUFA Reauthorization: Fiscal Years 2026 – 2030 webpage has been created to publish information as it becomes available on the negotiation process in developing recommendations for reauthorization of OMUFA for fiscal years 2026-2030. For those who wish to follow or participate in the process, please check the website often for announcements. The first public meeting took place in September 2023, videos of which can be accessed on the website. Comments may be made to Docket ID FDA-2023-N-3575.
On December 18, the FDA Announced Launch of Cosmetics Direct for Electronic Registration and Listing of Cosmetic Product Facilities and Products. The eagerly awaited program is now live for cosmetic facility registration and product listing submissions to the agency. EAS can assist with any questions you may have.
Per the FDA requires updates to labeling for promethazine hydrochloride injection products webpage, FDA has required that manufacturers update their prescribing information for promethazine hydrochloride injection to include new safety information and update the carton labeling and container labels with the corresponding information.
Reminder that CARES volume reporting has been an annual requirement since the passing of the CARES Act in 2020. The act mandates annual reporting for drug establishments, which is recommended to be filed in February.
The FDA has issued an Update on In-Person Face-to-Face Formal Meetings with FDA defining their hybrid format which includes both in person, face to face, and virtual face to face components. The virtual face to face would include both audio and visual communication. Please see the website for full details.
The FDA has updated their website: How to Prepare a Traditional 510(k). Please review for details.
The CDRH Portal has been updated, specifics can be found on the FDA’s Send and Track Medical Device Premarket Submissions Online: CDRH Portal website.
Updates to the eSTAR Program were announced in December.
The List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic has been updated.
Highlighted Guidance Documents
The purpose of this guidance is to provide recommendations for applicants and manufacturers on what tests should be performed and what documentation should be submitted or available to FDA to support the reformulation of drug products that use carbomers manufactured with benzene. Certain USP carbomer monographs currently allow for unacceptable levels of benzene, which raises safety concerns. FDA has requested that the USP omit (or remove) these monographs, and applicants and manufacturers may need to reformulate their drug products to avoid using these carbomers. This guidance provides recommendations for testing and documentation related to reformulation, taking into consideration the various routes of administration and dosage forms of affected drug products. For application holders, this guidance also recommends appropriate submission types to notify the Agency of such changes.
The FDA is announcing the availability of a final guidance for industry entitled “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.” The guidance addresses the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place to comply with the FD&C Act, as amended by the DSCSA.
This technical specifications document represents the FDA’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, send an email to firstname.lastname@example.org or email@example.com.
This guidance provides recommendations for presenting quantitative efficacy and risk information in direct-to-consumer promotional labeling and advertisements for prescription human drug and biological products and prescription animal drugs and in DTC promotional labeling for nonprescription animal drugs (collectively, promotional communications). For the purposes of this guidance, quantitative efficacy and risk information refers to information that numerically addresses the likelihood or magnitude of a drug’s efficacy or risks.
Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule Questions and Answers
This guidance is intended to help small entities understand and comply with the standards established in the final rule, “Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format” (CCN Final Rule) (88 FR 80958, November 21, 2023). Section 502(n) of the Federal Food, Drug and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA), requires that human prescription drug advertisements presented directly to consumers in television or radio format that state the name of the drug and its conditions of use present the major statement relating to side effects and contraindications (“major statement”) in a clear, conspicuous, and neutral manner. The CCN Final Rule modifies 21 CFR 202.1(e)(1) to reflect this requirement and establishes standards to help ensure the major statement in these advertisements is presented in the manner required.
Per the 21st Century Cures Act, signed into law on December 13, 2016 the FDA has created a framework for a program to evaluate the potential use of real-world data (RWD) to generate RWE to help support the approval of new indication(s) for drugs already approved under section 505(c) of the FD&C Act (21 U.S.C. 355(c)) or to help support or satisfy post-approval study requirements (RWE Program).
Resulting from the 21st Century Cures Act, signed into law on December 13, 2016, FDA has created a framework for a program to evaluate the potential use of real-world data (RWD) to generate RWE to help support the approval of new indication(s) for drugs already approved under section 505(c) of the FD&C Act (21 U.S.C. 355(c)) or to help support or satisfy post-approval study requirements (RWE Program).
Draft Guidances for Comment
- DRAFT Guidance Clinical Pharmacology Considerations for Peptide Drug Products
Comments may be submitted to Docket ID FDA-2023-D-3391
- DRAFT Guidance Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act
Submit Comments by 01/08/2024
- DRAFT Guidance Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act – Revision 2
Submit Comments by 01/08/2024
- DRAFT Guidance Advanced Manufacturing Technologies Designation Program
Submit Comments by 02/12/2024
- DRAFT Guidance Draft: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
Submit Comments by 02/20/2024
- DRAFT Guidance 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review
Submit Comments by 02/20/2024
- DRAFT Guidance Quality Considerations for Topical Ophthalmic Drug Products
Submit Comments by 02/26/2024
All Guidance Documents can be searched on the FDA’s website.
Date: January 18, 2024
Time: 1:00 PM – 3:00 PM ET
Date: February 13 – 15, 2024
Day 1: Tue, Feb 13 8:30 AM – 3:35 PM ET
Day 2: Wed, Feb 14 8:30 AM – 3:50 PM ET
Day 3: Thu, Feb 15 8:30 AM – 4:50 PM ET
Date: March 14 – 15, 2024
Time: 8:30am – 4:40pm EDT
FDA Websites of Interest
- An adaptive trial design for testing the bioequivalence of generics of highly variable drugs
- What do I need to know about supply chain security requirements under the Drug Supply Chain Security Act (DSCSA)?
- Wholesale Distributor and Third-Party Logistics Providers Reporting
- Check Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers
- MAPP, Assessment of Facility-Based Deficiency Major-to-Minor Reclassification Requests
- Recognized Consensus Standards: Medical Devices
- Biosimilars | Science and Research
- FDA Releases Final Guidance on Enforcement Discretion for Certain NAC Products
- The Importance of Clinical Trial Transparency and FDA Oversight
Posted in Drug and Device Corner.