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Life Sciences › Federal Food Drug and Cosmetic Act (FFDCA) › Comment Period

Morgan Lewis - As Prescribed

A Clearer Path from FDA for ‘Minor Changes’ to Solid Oral Dosage Forms for OTC Monograph Drugs

Morgan Lewis - As Prescribed on

Recent FDA actions offer long-awaited clarity on what constitutes a ‘minor change’ to solid oral OTC dosage forms, providing manufacturers with a clearer pathway for certain modifications while maintaining a measured,...more

Jones Day

FDA on Board With Continuing Remote Inspections

Jones Day on

The Food and Drug Administration ("FDA") recently issued revised draft guidance on remote regulatory assessments ("RRAs")—voluntary or mandatory examinations of food, drug, device, and tobacco establishments and/or their...more

Nelson Mullins Riley & Scarborough LLP

FDA Revises Guidance Concerning Scientific Communications to HCPs about Unapproved Uses of Approved/Cleared Medical Products

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The U.S. Food and Drug Administration (FDA) issued a long-awaited revised draft guidance on October 23, 2023, which focuses on communications to healthcare providers (HCPs) regarding scientific information on unapproved uses...more

Nelson Mullins Riley & Scarborough LLP

FDA Proposes Drastic Overhaul of Laboratory Developed Test Regulation

Nelson Mullins Riley & Scarborough LLP on

Of particular interest to clinical laboratories and medical device manufacturers, the U.S. Food and Drug Administration (FDA or the Agency) released a controversial proposed rule on September 29 that would dramatically alter...more

Quarles & Brady LLP

The Clock is Ticking: Comments to Proposed Federal Rules For Wholesalers and 3PLs are Due June 6th and Here’s What We Think

Quarles & Brady LLP on

On February 4, 2022, the FDA released its long-awaited proposed national standards for the licensure of third party logistics providers (3PLs) and wholesale drug distributors. The draft rules were years over-due and the delay...more

Morgan Lewis

FDA Issues Long-Awaited Quality System Regulation Amendments

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After four long years and a series of delays, the US Food and Drug Administration released its proposed rule for amending the Quality System Regulation to be harmonized with ISO 13485:2016. In a somewhat surprising move, the...more

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