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FDA Issues Long-Awaited QMSR Final Rule

FDA Law Blog: Biosimilars

By Véronique Li, Senior Medical Device Regulation Expert & Ana Loloei & Allyson B. Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. Revised § 820.3

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Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

FDA Law Blog: Biosimilars

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. By Day 7 FDA sends Acknowledgment Letter.

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Understanding the Elements of a Typical IND-Enabling Package

The Premier Consulting Blog

While the type, number, and design of these studies vary based on product-specific characteristics, IND-enabling packages submitted to the FDA generally include key information about the pharmacology, pharmacokinetics, and toxicology of the product.

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What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

FDA Law Blog: Drug Discovery

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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Importance of FDA Combination Products

Pharmaceutical Development Group

Introduction FDA (can also be expanded as the Food and Drug Administration) is a bureau that administers the public’s welfare by controlling and surveillance of food products, medications, vaccines, medical devices, etc. There are certain rules and criteria for post marketing safety reporting of FDA combination products.

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Article FDA: FDA set to unveil new rule on Laboratory Developed Tests this August

Agency IQ

FDA set to unveil new rule on Laboratory Developed Tests this August Following challenges getting a diagnostics reform package through Congress, known as the VALID Act, the FDA has just announced that it plans to release a proposed rule in August 2023 that would change the way that the agency effectively regulates laboratory developed tests (LDTs).

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PreSTAR: a New Template for Pre Submissions and 513(g) Requests for Information

FDA Law Blog: Biosimilars

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently released a new eSTAR template for device pre-submissions and 513(g) Requests for Information, referred to as PreSTAR. package labeling is optional). not subject to premarket review).

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