The FDA has announced the 2023 OMUFA user fee rates, please see the Over-The-Counter Monograph Drug User Fee Program (OMUFA) website for full details. Monograph Drug Facility (MDF) Facility fee: $26,153; Contract manufacturing Organization (CMO) Facility Fee: $17,435. The annual fee is due no later than 1 June 2023.
EAS’ webinar An Introduction to Upcoming Modernization of Cosmetics Regulation Act (MoCRA) is available for viewing for anyone that may have missed this informative presentation by EAS Independent Consultants John and Catherine Bailey. One noted development is that the agency has stopped accepting registrations via their exiting voluntary system. FDA wants industry to await announcement of the developed program. We will continue to keep you informed of MoCRA details as they emerge.
After a draft publication of the International Council for Harmonisation (ICH) Q13 Continuous Manufacturing of Drug Substances and Drug Products in October 2021, the FDA accepted and reviewed comments via Docket ID FDA-2021-D-1047 on Regulations.gov. The recently published guidance offers clarity on continuous manufacturing concepts and articulates its application to CM of drug substances and drug products for chemical entities and therapeutic proteins, although noted that other biological/biotechnological entities could benefit from the principles described in the guidance. This guidance also covers the conversion of batch manufacturing to CM for existing products. Fundamental aspects: Concepts, Scientific Approaches and Regulatory Considerations, are clearly laid out in the guidance with annexes offering illustrative examples of implementation.
Are you ready for Medical Device transition from policies implemented during the health emergency to normal operations and regulatory enforcement? The FDA has issued two guidance documents and has planned a webinar to discuss the timeline and particulars. If you have questions on your company’s readiness, EAS can assist with a 21 CFR 820 audit. We also have consultants to support submission on 510(k)s.
FDA is issuing this guidance to provide its recommendations and expectations to manufacturers of devices that were issued emergency use authorizations (EUAs) related to COVID-19 to transition to normal operations when the declarations that allowed for FDA to issue EUAs under section 564 of the Federal Food, Drug, and Cosmetic Act end. FDA believes the policy set forth in this guidance will help FDA and other stakeholders transition to normal operations and processes.
FDA is issuing this guidance to provide its recommendations and expectations to manufacturers of devices that fall within certain enforcement policies issued during the COVID-19 public health emergency to transition to normal operations when the public health emergency declaration related to COVID-19 under section 319 of the Public Health Service Act ends. FDA believes the policy set forth in this guidance will help FDA and other stakeholders transition to normal operations and processes.
Webinar on Guidances on COVID-19 Transition Plans for Medical Devices
Date: April 18, 2023
Time: 1:00 PM – 2:30 PM ET
For those who may have missed it, on 8 March 2023 the FDA issued marketing authorization for a de novo device and established Product Code QVF, a class II simple point-of-care device to directly detect sars-cov-2 viral targets from clinical specimens in near-patient settings. A 510(k) pathway is now available for medical devices demonstrating substantial equivalence to this predicate device.
EAS has noticed a bit of an uptick in FDA Warning Letters citing CGMP/Finished Pharmaceuticals/Adulterated. These WLs not only included cGMP non-compliance, but also failure to correctly register and /or list drug products. EAS is here to support our clients with audits, mock-inspections, and registration and drug listing assistance. Please reach out to Victoria Pankovich for further information.
Reminder that CARES Act drug reporting is an annual requirement since being passed in 2020. If you have not already submitted your 2020, 2021, and / or 2022 reports, please do so at your earliest convenience. If you need assistance with this process, EAS is here to help.
Highlighted Guidance Documents
This draft guidance provides information for sponsors, clinical investigators, institutional review boards, contract research organizations, and other interested parties on the use of electronic systems, electronic records, and electronic signatures in clinical investigations of foods, medical products, tobacco products, and new animal drugs under FDA regulations. The guidance provides recommendations regarding the requirements, including the requirements under 21 CFR part 11, under which FDA considers electronic systems, electronic records, and electronic signatures to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. (EDIT)
This guidance describes the FDAs approach regarding manufacturers’ compliance with FDA’s performance standards for laser products.
The FDA is announcing the availability of a draft guidance for industry entitled “Pharmacogenomic Data Submissions.” This draft guidance is intended to facilitate progress in the field of pharmacogenomics and the use of pharmacogenomic data in drug development. The draft guidance is intended to clarify the contexts in which pharmacogenomic study findings and data must be included in submissions related to INDs, NDAs, and BLAs based on the FDA’s regulations. In addition, this document provides recommendations to sponsors and applicants on the format and content of the pharmacogenomic data submissions.
The DSCSA amended the FD&C Act to establish requirements for product tracing, verification, and product identification for certain drug products that are distributed in the United States. Many of the terms used in these requirements are defined in section 581 of the FD&C Act (21 U.S.C. 360eee).
All Guidance Documents can be searched on the FDA’s website.
FR Vol 88, No. 58 Over-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2023
Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF
Date: April 12 – 13, 2023
Day1: Wed, Apr 12
8:00 AM – 5:30 PM ET
Day2: Thu, Apr 13
8:00 AM – 4:55 PM ET
FDA’s Dosage and Administration Section of Labeling Draft Guidance
Date: April 19 – 20, 2023
Day1: Wed, Apr 19
1:00 PM – 2:30 PM ET
Day2: Thu, Apr 20
1:00 PM – 2:30 PM ET
Electronic Systems, Electronic Records, and Electronic Signatures Webinar
Date: April 25, 2023
Time: 3:00 PM – 4:30 PM ET
Navigating the First ICH Generic Drug Draft Guideline “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms” WEBINAR
Date: May 2, 2023
Time: 1:00 PM – 3:00 PM ET
FDA Websites of Interest
Q8: What Purple Book reporting requirements were added by section 3201 of the Consolidated Appropriations Act of 2023 enacted December 29, 2022?
A8: Section 3201 of the Consolidated Appropriations Act of 2023 amended section 506I of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to include applications approved under subsection (a) or (k) of section 351 of the Public Health Service Act (PHS Act). As amended, section 506I imposes certain reporting requirements on biologics license application (BLA) holders regarding the marketing status of approved products, including a one-time marketing status report.
Section 506I(c) of the FD&C Act requires that all BLA sponsors review information published in the Purple Book and submit a one-time written report to FDA indicating that:
- the BLA sponsor’s product(s) in the Purple Book that have a status of “Rx” are available for sale; or
- one or more of the BLA sponsor’s products in the Purple Book that have a status of “Rx” have been withdrawn from sale or have never been available for sale.
Section 506I(c) of the FD&C Act requires that this one-time marketing status report be submitted to the FDA within 180 days of enactment (i.e., by Tuesday, June 27, 2023).