RA/QA News Roll: Late 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.

If you haven’t upgraded to a paid subscription yet, you can do so here.

Here are some key items from the past couple of weeks.

FDA Guidances

---

• The FDA has introduced fresh guidance regarding Prescription Drug Use Related Software (PDURS)—software used alongside a drug to provide guidance for its proper usage. Instead of treating PDURS as a distinct medical device, the FDA is proposing to regulate it as an integral part of product labeling.

• The FDA has issued new guidance outlining considerations for conducting clinical trials of medical products during significant disruptions caused by disasters and public health emergencies.

• The FDA has issued new guidance concerning electronic submission templates for medical device de novo requests.

• The FDA has introduced a significant new draft guidance document on using remote oversight tools to assist in approving drugs as part of their applications for approval. (Read our detailed breakdown below.)

  [Bonus Issue] Inside FDA's New Draft Guidance on Using "Alternative Tools" for Manufacturing Inspections

• The FDA has released a new draft guidance document regarding formal meetings between the agency and sponsors of PDUFA (Prescription Drug User Fee Act) products. This revised guidance seems to encompass Type D and INTERACT meeting information.

• A new medical device guidance document has been issued, focusing on device cybersecurity and providing guidance on how companies can demonstrate to the FDA that cybersecurity is an integral part of their quality system.

• The FDA has issued new guidance specifically addressing Graft-Versus-Host (GVH) diseases, which arise when a patient receives donated tissue from another person. Managing GVH diseases typically involves the use of drugs and biologics. The FDA's guidance is intended to provide clarity on the development and testing of these products to facilitate the approval process.

• A new final guidance document has been released on "dose banding," which involves labeling drug or biological products based on weight or body surface area.

FDA General

---

• The FDA has officially released its proposed rule on Laboratory Developed Tests (LDTs). As anticipated, this rule aims to amend FDA regulations to explicitly define In Vitro Diagnostic Devices (IVDs) as devices under the Federal Food, Drug, and Cosmetic Act, even when these IVDs are manufactured by laboratories. Alongside this amendment, the FDA is proposing a policy shift in which it intends to increase oversight of LDTs. This change involves phasing out the agency's general enforcement discretion approach to LDTs. Watch FDA’s medical call below.

  • In response, the American Clinical Laboratory Association (ACLA) has expressed opposition to the rule, contending that it exceeds the FDA's authority. The release of the proposed rule represents a significant development in the regulation of LDTs in the United States.

• CBER has released a new Standard Operating Policies and Procedures (SOPP) document outlining its protocols for managing Regenerative Medicine Advanced Therapy (RMAT) products. This document covers various aspects, including the process for requesting designation, sponsor interactions, and status assessments.