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FDA Seeks Comments on Potential Marijuana Reclassification Under International Drug Control Treaty
  • Jackson Lewis PC
  • USA
  • April 19 2018

The Food and Drug Administration requested comments in a notice published in the Federal Register on April 9, 2018 concerning the “abuse potential


Drop in Warning Letters for Medical Devices Raises Interesting Questions About the Industry
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • April 18 2018

In 2017, FDA issued only 44 Warning Letters to medical device establishments. Of those, 11 were related to pre-market issues, which include


FDA inspection proposal provides valuable insight into scope of investigations
  • Keller and Heckman LLP
  • USA
  • April 18 2018

At yesterday’s meeting with the U.S. House Subcommittee on Agriculture and Rural Development to discuss FDA’s Fiscal Year 2019 budget, Food and Drug


FDA Guidance on Using Public Human Genetic Variant Databases for Genetic and Genomic-Based In Vitro Diagnostics
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • April 18 2018

On April 13, 2018, FDA issued final guidance on the Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and


USP Will Not Revise Its Biologics Monograph Without Stakeholder Consensus
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • April 18 2018

On April 2, 2018, the United States Pharmacopeial Convention (“USP”) issued a statement that it will not develop a new monograph for a biologic unless


FDA Weighs In on When Pregnant Patients Should be Included in Clinical Trials
  • Hogan Lovells
  • USA
  • April 18 2018

In a recently issued draft guidance for industry, FDA encourages drug sponsors to consider the inclusion of pregnant subjects in clinical studies


States Stepping into the Breach on Drug-Pricing Transparency
  • FisherBroyles LLP
  • USA
  • April 17 2018

In recent months President Trump, Food and Drug Administration Commissioner Scott Gottlieb, and Health and Human Services Secretary Alex Azar have all


Industry objects to FDA's position on soy protein and heart health
  • DLA Piper
  • USA, Canada
  • April 17 2018

In a statement filed with the FDA on March 19, the Center for Responsible Nutrition, which represents the US dietary supplement industry, took issue


FDA to Consider Approval of Botanical (not synthetic) CBD Drug
  • Duane Morris LLP
  • USA
  • April 17 2018

On Thursday April 18, 2018, at 8:00AM-12:30PM EST, an FDA advisory panel will consider whether to recommend or not recommend approval of GW


Materiality Part III: It Is Not Enough That The Government Could Refuse PaymentThe Question Is Whether The Government Would Refuse Payment
  • Sheppard Mullin Richter & Hampton LLP
  • USA
  • April 16 2018

In Part II of our series, we discussed government knowledge. When the government knows of a claim’s falsity, but nevertheless pays the claim, the