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Results:1-10 of 463

New draft guidance proposes a shift in how the FDA will evaluate certain device modifications
  • Hogan Lovells
  • USA
  • October 10 2018

On September 28, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance document, entitled "The Special 510(k)


FDA schedules public hearing on solutions to drug shortages
  • Hogan Lovells
  • USA
  • October 8 2018

FDA schedules public hearing on solutions to drug shortages October 08, 2018 The U.S. Food and Drug Administration (FDA) has announced it will hold a


FDA Issues Draft Guidance on Publishing Retail Consignees Lists to Effectuate Certain Human and Animal Food Recalls
  • Hogan Lovells
  • USA
  • October 3 2018

On September 26, 2018, the Food and Drug Administration (FDA or the agency) issued a statement by FDA Commissioner Scott Gottlieb, M.D. on FDA's


FDA Issues Request for Information Regarding Use of Names of Dairy Foods in the Labeling of Plant-Based Products
  • Hogan Lovells
  • USA
  • October 3 2018

The Food and Drug Administration recently issued a request for information on the use of the names of dairy foods in the labeling of plant-based


FDA Announces Pilot Program for Two-Tier Preventive Controls for Human Food Inspections under FSMA
  • Hogan Lovells
  • USA
  • October 1 2018

The U.S. Food and Drug Administration (FDA) recently announced that it will engage in a pilot program to evaluate the benefits of two-tier inspections


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 Proposes New Rule to Increase Transparency and Access to Agency Documents Under FOIA
  • Hogan Lovells
  • USA
  • September 17 2018

The Food and Drug Administration (“FDA” or “the agency”) recently issued a proposed rule that will ease the Freedom of Information Act (“FOIA”)


Navigating the U.S. FDA regulatory clearance for digital medical devices: the 510(k) and Pre-Cert program
  • Hogan Lovells
  • USA
  • September 11 2018

Consumer demand for digital health care devices has soared, and it shows no signs of slowing down. But when bringing these devices to market


FDA publishes internal policy on prioritizing surveillance inspections for drug manufacturing sites
  • Hogan Lovells
  • USA
  • September 5 2018

Earlier today, FDA Commissioner Scott Gottlieb, M.D., made publicly available for the first time FDA’s internal policy (MAPP 5014.1) for how drug


FDA Issues Update to Facility Registration Guidance and New Supplemental Draft Guidance
  • Hogan Lovells
  • USA
  • August 27 2018

The U.S. Food and Drug Administration (FDA) recently issued two guidance documents to assist establishments in determining whether they have an