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Continuing Coverage of FDA’s Crackdown on Stem Cell Clinics: Florida Clinic Cited for Unapproved Marketing and Inadequate Sterility Assurance
  • Hogan Lovells
  • USA
  • September 20 2017

On the same day that FDA’s Commissioner, Dr. Scott Gottlieb, announced new policy initiatives regarding stem cell therapies and regenerative medicine


FDA embraces real-world evidence in new final guidance
  • Hogan Lovells
  • USA
  • September 15 2017

On August 31, 2017, the U.S. Food and Drug Administration (FDA) finalized its guidance document entitled, "Use of Real-World Evidence to Support


Life Sciences: Spotlight interview on false advertising claims in Europe
  • Hogan Lovells
  • European Union, Germany, USA
  • September 13 2017

Life sciences businesses dedicate huge resources to advertising material in a fiercely competitive market. Partner Tanja Eisenblätter discusses false


U.S. - What does the Impression Products v. Lexmark decision mean for drug companies? 5 takeaways
  • Hogan Lovells
  • USA
  • September 11 2017

Last May, the U.S. Supreme Court issued a highly-anticipated decision in Impression Products, Inc. v. Lexmark Int’l, Inc., reversing the Federal


New Jersey Joins Wave of States Proposing New Rules for Drug Marketing and HCP Interactions
  • Hogan Lovells
  • USA
  • September 11 2017

Drug manufacturers are once again facing new state limits on marketing and interactions with healthcare providers. Manufacturers should review the new


FDA Seeks Comments to Identify Regulations for Modification, Repeal, or Replacement
  • Hogan Lovells
  • USA
  • September 8 2017

The U.S. Food and Drug Administration (FDA) has issued a broad request for comment to assist the agency in identifying regulations and related


Unburden Yourself: FDA Requests Comments on Ways to Implement President Trump’s Regulatory Reform Executive Orders
  • Hogan Lovells
  • USA
  • September 8 2017

Earlier this year, in an effort to alleviate unnecessary regulatory burdens, President Trump issued two executive orders, Executive Order 13771


California's Proposition 65 Warning Requirements for Furfuryl Alcohol Will Become Effective Soon
  • Hogan Lovells
  • USA
  • September 5 2017

Effective September 30, 2017, California's Office of Environmental Health Hazard Analysis (OEHHA) will require warnings for consumer products


FSMA Update: FDA Begins FSVP Inspections
  • Hogan Lovells
  • USA
  • August 31 2017

FDA has started conducting inspections to assess compliance with its Foreign Supplier Verification Programs (FSVP) regulation. The initial FSVP


To the Spoiler Go the Spoils: OIG Approves Limited Product Replacement Program
  • Hogan Lovells
  • USA
  • August 30 2017

A perennial question for manufacturers of drugs and biologicals that require specialized handling, storage, or reconstitution is how to handle