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Regulatory Requirements › Product Defects › Food and Drug Administration (FDA)

Gardner Law

Product Liability Prevention: A Proactive Approach for FDA-Regulated Industries

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Medical device, drug, food, cosmetic, and other FDA-regulated product manufacturers face the constant threat of product liability lawsuits. Claims of injuries from allegedly defective products can lead to significant...more

Morrison & Foerster LLP

FDA Issues Action Levels for Lead in Baby Food

Morrison & Foerster LLP on

On January 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final guidance establishing action levels for lead in processed food intended for babies and young children. This is the first FDA guidance directly...more

Gardner Law

[Hybrid Event] “Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies - May 1st, Austin, TX

Gardner Law on

Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more

Hogan Lovells

FDA updates VMSRP instructions for summary MDR reporting – including reasons for possible program exclusion

Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) updated the information regarding its Voluntary Malfunction Summary Reporting Program (VMSRP) on the FDA Medical Device Reporting (MDR) web page....more

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