RA/QA News Roll: Mid September 2023
Here's what's happening at FDA and across the broader life science RA/QA space.
This is our biweekly recap of news and industry happenings curated for our paid subscribers. Our goal is to bring you the headline news and the stories, research, and insights that might be harder to find.
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Here are some key items from the past couple of weeks.
The FDA has released two final guidance documents pertaining to the Drug Supply Chain Security Act (DSCSA). This act, aimed at preventing counterfeiting, will be effective from November. However, the FDA has postponed its enforcement by a year. The first guidance addresses the verification requirements for returned drug products by wholesale distributors. The second guidance focuses on heightened security measures at the package level.
Predicate Device Selection: Outlining four best practices for selecting a predicate device to back a 510(k) submission.
Clinical Data Requirements: Providing further context on when clinical data might be essential to prove substantial equivalence.
Implant Considerations: Addressing considerations applicable to all kinds of implants under the 510(k) guidelines.
The FDA has scheduled a webinar for October 26 to discuss its new draft guidances aimed at modernizing the 510(k) program. Participants will be able to learn more about the proposed changes and the FDA's vision for the program's future.
The FDA has issued a new draft guidance document concerning nonclinical testing for medical devices indicated for weight loss. This guidance provides recommendations and insights into the nonclinical testing requirements for such devices.
The FDA has released a new final guidance document focusing on integrating human factors engineering principles for combination products. "Human factors" pertains to the ease of use of a product by a patient or their caregiver, ensuring that the product is user-friendly and minimizes potential errors in its application.
CDRH has published a new final guidance document related to the Breakthrough Devices Program, specifically focusing on "reducing disparities in health and health care." This guidance aims to provide clarity and direction for stakeholders participating in the program. Additionally, the FDA plans to conduct a webinar to discuss further and elaborate on the guidance in the coming months.
The FDA has released a new final guidance document that outlines the information necessary for annual status reports related to postmarketing requirements (PMRs) and commitments (PMCs). PMRs and PMCs are studies and activities mandated by the FDA as conditions for the approval of drugs and biologics. This guidance details what should be included in these annual status reports.
The FDA has introduced a new final guidance document detailing the Voluntary Improvement Program for medical devices. This program is designed to enhance the quality of medical devices, and the guidance provides insights and instructions for its implementation.
The FDA has introduced a new final guidance document concerning the application of ISO 10993-1, a standard associated with biocompatibility evaluation. The FDA has updated the guidance to reflect its current stance on the kind of biocompatibility data that should be included in a premarket submission for specific devices made from common polymers and fabrics that come into contact with unbroken skin.
The FDA has released a new guidance document concerning post-warning letter meetings as part of the recently reauthorized Generic Drug User Fee (GDUFA) program. The guidance provides information on the Post-Warning Letter Meeting process for certain facilities. Let’s break it down:
A Post-Warning Letter Meeting is a discussion with the FDA about a facility's efforts to address deficiencies identified in a warning letter. The guidance outlines how an eligible facility can request such a meeting, how to prepare and submit a meeting request package, and how the FDA intends to conduct the meeting.
The Generic Drug User Fee Amendments of 2012 (GDUFA I) authorized the FDA to collect user fees to ensure patients have access to quality, affordable, safe, and effective generic drugs. GDUFA has been reauthorized every five years, with the latest reauthorization being the Generic Drug User Fee Amendments of 2022.
The FDA has committed to specific performance goals related to Post-Warning Letter Meeting requests. By FY 2024, 50% of eligible requests will be addressed within 30 days. By FY 2025, 70% of eligible requests will be addressed within 30 days. By FY 2026 and FY 2027, 80% of eligible requests will be addressed within 30 days.
Generally, these meetings will take place 6 months or later after the facility submits an initial response to the FDA warning letter. A facility can request an earlier meeting; the FDA may grant it if deemed beneficial. Holding such a meeting does not prevent the FDA from taking regulatory actions. Meetings can be conducted via video conference, teleconference, or face-to-face at the FDA's discretion.
A facility is eligible for a Post-Warning Letter Meeting if:
Its CGMP compliance status is "Official Action Indicated" (OAI) due to an FDA inspection.
It has paid a GDUFA facility fee for the current fiscal year or is named in a pending ANDA application.
The regulatory action is limited only to violations related to human drug manufacturing.
In making a meeting request, a complete meeting package should be submitted electronically. The package should include the CAPA plan and supplementary information demonstrating ongoing remediation efforts. FDA will only accept requests from the facility, parent company, or authorized legal representative. The meeting package should be separate from the firm's warning letter response.
The FDA has completed a proposed rule centered on "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." This rule aims to set criteria for identifying drug substances that are challenging to compound and to specify certain drug categories.
The FDA’s Office of Pharmaceutical Quality has released two new Manuals of Policy and Procedures. The first manual delves into the "Responsibilities for the Assessment of In Vitro Testing for Oral Drug Products Administered Via Enteral Feeding Tube," providing guidance on the evaluation process for such products. The second manual, titled "Using Four-Part Harmony in Quality-Related Assessment Communications," offers insights into effective communication strategies related to quality assessments.
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