RA/QA News Roll: Mid-June 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 as well as the stories, research, and insights that might be harder to find.

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Here are some key items from the past few weeks.

FDA Guidances

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• FDA announced final guidances on Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals and Drug-Drug Interaction Assessment for Therapeutic Proteins, as well as draft guidance on Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment.

• FDA recently released a final guidance document on Requests for Feedback and Meetings for Medical Device Submissions, known as the Q-Submission Program. The document includes minor updates and clarifications, such as the timeframe for holding a pre-sub meeting, expectations for meeting minutes, and the submission process for various requests. It also emphasizes the importance of obtaining feedback on Predetermined Change Control Plans and addresses the inclusion of submissions associated with the Safer Technologies Program. The guidance also highlights separate processes for feedback on Medical Device Development Tools and Emergency Use Authorizations. Additionally, it suggests electronically submitting eCopy packages and advises against expecting FDA comments on new information provided after submitting a pre-submission package. The FDA recommends limiting the scope of the submission to ensure a more focused discussion if a meeting exceeds an hour.

• FDA released a revised guidance document regarding the evaluation of user fees under the Generic Drug User Fee Amendments of 2022. This updated guidance, which closely resembles the previous version issued in May 2023, has been modified to align with the GDUFA III agreement.

FDA General

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• FDA recently released its Spring 2023 regulatory agenda.

• CDER’s Office of Surveillance and Epidemiology released its 2022 annual report, detailing the office’s response to multiple public health emergencies, as well as its efforts to detect, prevent and manage risks to public health.