Final reminder that OMUFA facility user fees are due 1 June 2024.
Per MoCRA, responsible persons are required to submit any serious adverse event reports to the FDA within 15 business days of receiving such report. Cosmetic labels are required to include a domestic address, domestic phone number, or electronic contact information as of 29 December 2024. This contact information is necessary for end users to report any adverse events. Reach out to EAS if you have any questions.
Although NDC drug labeling SPL files should be updated as labeling changes occur, June is the designated time to submit such changes to FDA prior to the annual renewal period during October-December. This is a good time to schedule a review of your NDC listings and ensure all are up to date and accurate. Verifying information now can alleviate end of the year pressure to confirm which listings can be certified and which require an update to be submitted.
Analytical labs performing any testing or analysis on drug products destined for US commercial distribution are required not only to register their facility with the FDA as a drug establishment, but to also list the drug products analyzed at their facility. This includes facilities performing incoming materials testing, in-process control testing, and stability testing on drug products whose finished dosage form will enter US commercial distribution. NDC listings of tested drug products should be identifying these testing facilities in their SPL files.
On 21 May 2024, the FDA announced an extension of 60 days for the comment period on the Proposed New Regulations for Animal Drug Labeling which was announced in the Federal Register Vol. 89, No. 49. The proposed regulation would codify content and formatting of labeling for approved and conditionally approved new animal drugs. Please see the Federal Register notice if you wish to submit a comment.
Highlighted Guidance Documents
Remanufacturing of Medical Devices
This final guidance is intended to help clarify whether activities performed on devices are likely “remanufacturing.” This final guidance also clarifies existing regulatory requirements for remanufacturers and includes recommendations for information that should be included in labeling to help assure the continued quality, safety, and effectiveness of devices that are intended to be serviced over their useful life.
Providing Regulatory Submissions in Electronic Format: IND Safety Reports Guidance for Industry
This guidance describes the electronic format sponsors will be required to use when they
electronically submit to the FDA investigational new drug application safety reports for serious and unexpected suspected adverse reactions that are required under 21 CFR 312.32(c)(1)(i).
DRAFT GUIDANCE Submit Comments by 06/28/2024
Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency
DRAFT GUIDANCE Submit Comments by 07/05/2024
DRAFT GUIDANCE Submit Comments by 07/05/2024
CVM GFI #290 (VICH GL61) – Pharmaceutical Development
DRAFT GUIDANCE Submit Comments by 07/05/2024
REMS Logic Model: A Framework to Link Program Design With Assessment
DRAFT GUIDANCE Submit Comments by 08/05/2024
DRAFT GUIDANCE Comments may be made to Docket Number FDA-2024-D-1244
Platform Technology Designation Program for Drug Development
DRAFT GUIDANCE Comments may be made to Docket Number FDA-2024-D-1829
All Guidance Documents can be searched on the FDA’s website.
Federal Register
Federal Register Vol. 89, No. 69
Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments; Public Meeting; Request for Comments
Federal Register Vol. 89, No. 88 Medical Devices; Laboratory Developed Tests
Federal Register Vol. 89, No. 88 Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration Under Section 564; Draft Guidance for Laboratory Manufacturers and Food and Drug Administration Staff; Availability
Federal Register Vol. 89, No. 88 Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Meetings
Webinar – Enforcement Policies for Certain In Vitro Diagnostic Devices – Draft Guidances
Date: June 5, 2024
Time: 1:00 PM – 2:00 PM ET
OSIS Workshop: CDER Bioavailability/Bioequivalence Study Sites and Inspections of Good Laboratory Practice
Date: June 13, 2024
Time: 8:50 AM – 11:25 AM ET
Public Meeting: Optimizing FDA’s Use of and Processes for Advisory Committees
Listening Session
Date: June 13, 2024
Time: 9:00 AM – 4:00 PM ET
OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2024 User Fees and Registration
Date: June 18, 2024
Time: 1:00 PM – 2:00 PM ET
Webinar – Final Guidance: Remanufacturing of Medical Devices
Date: June 27, 2024
Time: 1:00 PM – 2:00 PM ET
Understanding Current Use of Ketamine for Emerging Areas of Therapeutic Interest
Date: June 27, 2024
Time: 9:00 AM – 4:00 PM ET
FDA Websites of Interest
- Product-Specific Guidances for Generic Drug Development
- The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter
- Biosimilars Action Plan
- Regulatory Science Tools Catalog
- EPA, FDA, and USDA Issue Joint Regulatory Plan for Biotechnology
- CDER Quantitative Medicine Center of Excellence (QM CoE)
- FY 2023 GDUFA Science and Research Report
- 2023 OND Annual Report
Posted in Drug and Device Corner, Drugs, Medical Devices.