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Results:1-10 of 589

Would you like an extra application with that? FDA mulls requiring dual applications for combination products
  • Hogan Lovells
  • USA
  • February 8 2019

On Tuesday, FDA announced the availability of a draft guidance, “Principles of Premarket Pathways for Combination Products,” with high-level


FDA to consider patent listing, therapeutic equivalence, and other Orange Book issues; agency will issue draft guidance documents, seek public comment
  • Hogan Lovells
  • USA
  • February 4 2019

FDA Commissioner Scott Gottlieb, M.D. recently announced four steps FDA will be taking to ensure that the Orange Book (FDA’s publication of Approved


In the midst of government shutdown, FDA pushes ahead with 510(k) modernization
  • Hogan Lovells
  • USA
  • January 24 2019

Thirty-two days into the longest government shutdown in U.S. history, the Food and Drug Administration (FDA or the agency) announced two developments


MDR single report exemption and ASRs: Coming to an end for most reporters
  • Hogan Lovells
  • USA
  • January 14 2019

The Medical Device Reporting (MDR) regulation provides a mechanism for the U.S. Food and Drug Administration (FDA or the Agency), as well as medical


Looking to 2019 and beyond - accessing the U.S. pharmabiotech market: U.S. drug inspections in China: Staying ahead of FDA enforcement trends
  • Hogan Lovells
  • USA, China
  • January 8 2019

China’s pharmaceutical manufacturing industry is amongst the largest, and, from a supply-chain perspective, one of the most important, in the world


Impact of Government Shutdown on Scope of FDA, FSIS, and CSPC Activities
  • Hogan Lovells
  • USA
  • January 4 2019

On December 22, 2018, funding expired for certain agencies within the federal government, including the Food and Drug Administration (FDA), the U.S


Likely FDA Impact of the Government Shutdown: Regulatory Submission Reviews, Inspections, and Research Projects
  • Hogan Lovells
  • USA
  • December 27 2018

The U.S. government shutdown that began December 22, 2018 affected only about a quarter of federal agencies, because most had already been funded for


FDA wants to hear from you: Proposed framework for regulating output of digital health tools accompanying prescription drugs as labeling
  • Hogan Lovells
  • USA
  • December 26 2018

On November 20, the Food and Drug Administration (FDA) published a request for comments on a proposed framework for regulating the output of digital


Nutrition Labeling Implementation Update - FDA Issues Technical Amendments to Final Rule
  • Hogan Lovells
  • USA
  • December 21 2018

The Food and Drug Administration (FDA) recently issued technical amendments to the final rule revising the nutrition labeling requirements. 1 These


President signs 2018 Farm Bill with hemp reforms implications for regulatory oversight of hemp-derived products including cannabidiol (CBD)
  • Hogan Lovells
  • USA
  • December 21 2018

On December 20, 2018, President Donald Trump signed the Agricultural Improvement Act of 2018 (the 2018 Farm Bill) into law. The 2018 Farm Bill