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FDA Proposed Rule Defining “Biological Product”
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • December 21 2018

On December 12, 2018, FDA issued a proposed rule to amend the definition of “biological product” to conform to the definition provided by BPCIA. The


FDA Issues Technical Amendments to Final Nutrition and Supplement Facts Rule
  • Keller and Heckman LLP
  • USA
  • December 20 2018

FDA will publish in the December 21, 2018 Federal Register a final rule that makes technical amendments to its 2016 final rule on Nutrition and


FDA Generic Labeling Proposal - Six, Two, and Even, Over and Out
  • Reed Smith LLP
  • USA
  • December 17 2018

We opposed the FDA’s ill-advised 2013 proposal to revamp the process for changing generic drug labeling from the outset. We had legal objections -


Public Health Groups Urge Court to Reject FDA’s Proposed Schedule for Graphic Health Warnings
  • Troutman Sanders LLP
  • USA
  • October 30 2018

Last month, the U.S. District Court for the District of Massachusetts found that FDA “unlawfully withheld” and “unreasonably delayed” the


FDA's Drug Centers Release New Draft Guidance on Quantitative Info in Consumer-Directed Ads
  • Mintz
  • USA
  • October 17 2018

In the first new guidance document from FDA in several years specific to the subject of direct-to-consumer (DTC) promotion of prescription drugs and


Trump Administration Proposes Requiring Disclosure of Drug Prices in TV Ads
  • Mintz
  • USA
  • October 17 2018

The Trump Administration is moving full speed ahead with its proposals under the Blueprint to Lower Drug Prices (the “Blueprint”). Earlier this week


FDA Releases Revised Draft Memorandum of Understanding for Human Drug Compounding
  • Duane Morris LLP
  • USA
  • October 1 2018

The U.S. Food and Drug Administration recently announced the release of a revised Draft Memorandum of Understanding (MOU), Addressing Certain


FDA Secures Additional Time to Submit Court-Compelled Expedited Schedule for a Final Graphic Health Warnings Rule
  • Troutman Sanders LLP
  • USA
  • September 28 2018

As a follow-up to our earlier blog post on this topic, the FDA now has until October 5, 2018 to provide an expedited schedule for the issuance of a


Impending Tariffs on China to Impact Manufacturers of Dietary Supplements, OTC Drugs, Cosmetics
  • Morgan Lewis
  • USA, China
  • September 19 2018

Newly approved tariffs would impose 10 to eventual 25 tariffs on hundreds of chemical ingredients imported from China used for many FDA-regulated


DOJ Announces Revised Opioid Anti-Diversion Policy
  • FisherBroyles LLP
  • USA
  • July 16 2018

Last week, the Department of Justice (DOJ) announced that it had finalized new rules to prevent the diversion of prescription opioids in a move