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Results:1-10 of 10,101

FDA Draft Guidance on Postapproval Changes to Drug Substances

Finnegan, Henderson, Farabow, Garrett & Dunner LLP
USA
September 25 2018

On September 10, 2018, the FDA issued draft guidance on Postapproval Changes to Drug Substances, with recommendations regarding changes to drug

New warnings about silicone breast implants dismissed by the FDA

Penningtons Manches LLP
USA, United Kingdom
September 25 2018

The Food and Drug Administration (FDA) in the US has pushed back on a recent study that suggests that there is an association between silicone breast

The Preventive Controls for Human and Animal Food Rules Take Effect

Rhoades McKee PC
USA
September 25 2018

As of September 17, 2018, food facilities of all sizes are required to be in full or partial compliance with the Preventive Controls for Human Food

Senate Overwhelmingly Clears Bipartisan Opioid Package

Squire Patton Boggs
USA
September 24 2018

Nearly three months following House passage of a legislative proposal related to America’s opioid epidemic, the Senate overwhelmingly cleared its own

Heck No, FDCA Violations Can’t Be Inferred Merely From Product Malfunctions

Reed Smith LLP
USA
September 24 2018

We recently commented on Sumpter v. Allergan, Inc., 2018 WL 4335519 (E.D. Mo. Sept. 11, 2018), for several reasons - all bad - but one stands out, the

By the Book: Hip Implant Claims Dismissed in Middle District of Florida

Reed Smith LLP
USA
September 21 2018

Recently, the Enviably Youthful Drug and Device Law Mother has been pushing us to plan a motherdaughter vacation. Her longtime companion no longer

Energy Drink Smackdown Begins in Cali Central

Baker & Hostetler LLP
USA
September 21 2018

Energy drink manufacturer Monster has accused VPX of marketing its BANG drinks like a “modern-day snake oil.” VPX, which produces a range of health

FDA finalizes two guidances clarifying DSCSA enforcement exemptions and issues product identifier Q&A

Hogan Lovells
USA
September 21 2018

Yesterday, the U.S. Food and Drug Administration (FDA) finalized two important Drug Supply Chain Security Act (DSCSA)-related guidances that aim to

FDA Commissioner discusses FDA’s efforts to prevent foodborne Cyclospora outbreaks

Keller and Heckman LLP
USA
September 20 2018

FDA Commissioner Scott Gottlieb has issued a press release in the aftermath of this summer’s Cyclospora (C. cayetanensis) outbreaks in fresh produce

OIG Recommends FDA Use Pre-submission Program to Evaluate Cybersecurity Risks

Dinsmore & Shohl LLP
USA
September 20 2018

In September 2018 the OIG published its report on the FDA’s review practices for medical devices with cybersecurity implications, referred to as

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