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FDA Draft Guidance on Postapproval Changes to Drug Substances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On September 10, 2018, the FDA issued draft guidance on Postapproval Changes to Drug Substances, with recommendations regarding changes to drug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