The comment period for this proposed administrative order has been reopened due to issues the FDA experienced with the commenting function. FDA had been using the OTC Monographs@FDA portal for comments. In light of the technical difficulties that occurred, the agency reopened the comment period for the proposed order (OTC000035) using the Federal eRulemaking Portal at Regulations.gov. Comments may be made by 27 September 2024.
EAS has been seeing increased scrutiny by the FDA of NDC drug labeling SPL file listings. The agency has recently issued a Warning Letter under the subject ‘Failure to Register and List’ to a company whose OTC monograph drug NDC listing details were found to be incorrect. If your company has not already established an NDC listing review process, you should consider creating one. 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 prior to the renewal period can alleviate end of the year pressure to confirm which listings can be certified and which require an update to be submitted.
The FDA has announced FY2025 user fees for GDUFA, MDUFA, OMUFA (without facility fees), PDUFA, BsUFA, and animal user fee programs. Please see the Federal Register section of DD Corner for further details on each.
FY2025 Medical Device facility registration user fees can be found on the FDA’s Medical Device User Fee Amendments (MDUFA) website. Do note, there are NO waivers or reductions of facility user fees for small establishments, businesses, or groups in FY2025. The $9,280 annual establishment registration fee must be paid PRIOR to submitting your annual renewal. Please review the MDUFA website for the remaining FY2025 medical device user fees. Medical device user fee types can be found on the FDA’s webpage.
For businesses that may qualify as a ‘Small Business’ for CDRH’s Small Business Program, keep in mind an application must be submitted annually to continue to participate in the program. The Reduced Medical Device User Fees: Small Business Determination (SBD) Program website has full details and information on the process.
For clients that have been submitting cosmetic facility registrations and cosmetic product listings to FDA via Cosmetics Direct, you may have noticed a lack of functionality for some needed features. The agency has announced updates to the system which include a discontinuation of cosmetic product listing; and relisting of cosmetic product that had been discontinued and is being brought back to the market. The agency notes that a discontinued product is different than a deleted product. If a product is discontinued in the system, it remains in the SPL file and can be re-listed if brought back to market. Alternatively, a product that is deleted will be permanently removed from the SPL file and cannot be retrieved for relisting. The website offers links for helpful resources. As always, EAS is here for support if needed.
The drug, medical device, and food facility registration renewal periods begin 1 October 2024, which is just around the corner. EAS is happy to assist any client that requires support with this process. Reach out to Victoria Pankovich if you need assistance.
Highlighted Guidance Documents
Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA
The FDA is announcing the availability of a final guidance for industry entitled “Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA.” This guidance provides recommendations to industry on product-specific guidance meetings between FDA and a prospective applicant preparing to submit to FDA, or an applicant that has submitted to FDA, an abbreviated new drug application under the FD&C Act. This guidance provides procedures that will promote well-managed PSG meetings and help ensure that such meetings are scheduled and conducted in accordance with the time frames set forth in the GDUFA III commitment letter. This guidance finalizes the draft guidance for industry of the same title issued on February 21, 2023.
Container Closure System and Component Changes: Glass Vials and Stoppers
FDA is issuing this guidance to collate recommendations for appropriate reporting categories and the content of post-approval change submissions across numerous FDA guidance documents. This guidance conveys recommendations to holders of approved NDAs, BLAs, and ANDAs regarding the reporting and implementation of some common changes to container closure system components consisting of glass vials and stoppers for approved sterile drug products, including biological products, administered parenterally. This guidance also discusses pathways available to application holders to obtain Agency feedback. Additionally, this guidance discusses risk-based tools available to facilitate the implementation of changes to CCSs consisting of glass vials and stoppers. This guidance does not apply to CCS types other than glass vials and stoppers.
Providing Over-the-Counter Monograph Submissions in Electronic Format
The FDA is announcing the availability of a final guidance for industry entitled “Providing Over-the-Counter Monograph Submissions in Electronic Format.” This guidance is intended to assist submitters by describing the electronic OTC monograph submissions requirement in the FD&C Act, and providing recommendations and other information on how to send such OTC monograph submissions to FDA in electronic format. This guidance finalizes the draft guidance of the same title issued on September 28, 2022.
Application User Fees for Combination Products
This document provides guidance to industry and FDA staff on application user fees for combination products as defined under 21 CFR 3.2(e). Combination products may be reviewed in a single application or in separate applications for the constituent parts, as appropriate. The guidance explains that combination products for which a single application is submitted should be assessed the applicable user fee associated with that particular type of application. The document also addresses how the Agency applies user fees for combination products when separate applications are submitted for the constituent parts.
The purpose of this guidance is to establish procedures for submitting, reviewing, and responding to requests for information regarding the class in which a device has been classified or the requirements applicable to a device under the the FD&C Act that are submitted in accordance with section 513(g). This guidance was updated to provide information regarding the voluntary submission of 513(g) Requests through the electronic Submission Template And Resource (eSTAR).
Electronic Submission Template for Medical Device De Novo Requests
This guidance provides the standards for the submission of De Novo Requests by electronic format, a timetable for establishment of these standards, and criteria for waivers of and exemptions from the requirements to meet a statutory requirement. As of October 1, 2025, FDA will require that De Novo Request electronic submissions be provided as described in this guidance.
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.
The FDA is announcing the availability of a final guidance for industry titled “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products.” FDA is issuing this guidance as part of its Real-World Evidence program. This guidance is intended to provide sponsors and other interested parties with considerations when proposing to use electronic health records or medical claims data in clinical studies to support a regulatory decision for effectiveness or safety. This guidance finalizes the draft guidance of the same title issued on September 30, 2021.
All Guidance Documents can be searched on the FDA’s website.
Federal Register
FR Vol. 89, No. 147 Generic Drug User Fee Rates for Fiscal Year 2025
FR Vol 89, No. 147 Medical Device User Fee Rates for Fiscal Year 2025
FR Vol 89, No. 147 Over-the-Counter Monograph Drug User Fee Program-OTC Monograph Order Request Fee Rates for Fiscal Year 2025
FR Vol 89, No. 147 Prescription Drug User Fee Rates for Fiscal Year 2025
FR Vol. 89, No. 147 Biosimilar User Fee Rates for Fiscal Year 2025
FR Vol. 89, No. 147 Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2025
FR Vol 89, No. 153 Office of Pharmaceutical Quality Experiential Learning Site Visit Program; Program Announcement
FR Vol 89, No. 153 Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Reopening the Comment Period
Meetings
FDA | NIH : Regulatory Do’s and Don’ts: Tips from FDA
Date: September 4, 2024
Time: 11:00 AM – 3:00 PM ET
Webinar – Final Guidance: Remanufacturing of Medical Devices
Date: September 10, 2024
Time: 1:00 PM – 2:00 PM ET
Webinar – Labeling Requirements for In Vitro Diagnostic Products (IVD), Including LDTs, Under 21 CFR 809.10(b)
Date: September 24, 2024
Time: 1:00 PM – 2:00 PM ET
Advancing Generic Drug Development: Translating Science to Approval 2024
Dates: September 24 – 25, 2024
Day1: Tue, Sep 24 8:30 AM – 4:35 PM ET
Day2: Wed, Sep 25 9:00 AM – 4:15 PM ET
FDA Websites of Interest
Posted in Drug and Device Corner, Drugs, Extra Article, Medical Devices.