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HHS Final Rule Expands ClinicalTrials.gov Reporting Requirements for Medical Device Studies
  • Hogan Lovells
  • USA
  • September 26 2016

Medical Device Alert On September 16, 2016, the Department of Health and Human Services (HHS) issued a final rule to expand the availability of


FDA Issues Draft Guidance on Co-Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices
  • Hogan Lovells
  • USA
  • September 22 2016

On September 21, 2016, FDA issued a draft guidance titled “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test


FDA Is Looking at the Money Trail: Agency Describes Potential Investigator Bias Based in Part on Industry Payments
  • Hogan Lovells
  • USA
  • September 19 2016

Last week, the U.S. Food and Drug Administration (FDA) issued a briefing document in advance of a joint advisory committee meeting held on Wednesday


It’s Final: Expanded Registration and Results Submission Requirements for ClinicalTrials.gov
  • Hogan Lovells
  • USA
  • September 19 2016

On September 16, 2016, the Department of Health and Human Services (HHS) issued a final rule that "clarifies and expands" the requirements for


Don’t Blink: 9th Circuit Issues Pivotal Decision on Enforcement of CSA Against Cannabis-ness
  • Hogan Lovells
  • USA
  • September 7 2016

As reported here, earlier this month the U.S. Drug Enforcement Administration (DEA) issued a decision declining to transfer marijuana out of Schedule


Certain Antiseptic Ingredients No Longer GRASGRAE, Says FDA
  • Hogan Lovells
  • USA
  • September 3 2016

FDA announced a final rule today determining that certain common ingredients, most notably triclosan and triclocarban, in over-the-counter consumer


FDA Revises Its Drug Establishment Registration, Drug Listing, and National Drug Code (NDC) Regulations
  • Hogan Lovells
  • USA
  • September 1 2016

Yesterday, the U.S. Food and Drug Administration (FDA) issued a final rule amending its regulations governing drug establishment registration and


Finally! FDA Announces Highly-Anticipated and Long-Awaited Public Hearing on “Off-Label” Communications
  • Hogan Lovells
  • USA
  • September 1 2016

In a Federal Register notice published September 1, 2016, the U.S. Food and Drug Administration (FDA) announced a public hearing for November 9-10


A Renewed Focus on Quality: FDA Issues Proposed Rule Amending GLP Regulations
  • Hogan Lovells
  • USA
  • August 31 2016

On August 24, 2016, FDA published a proposed rule that amends the regulations regarding good laboratory practice (GLP) under 21 CFR part 58. GLPs must


GAO Report Suggests Data Needed for CMS to Evaluate How Coupon Discounts Impact Medicare Part B Spending
  • Hogan Lovells
  • USA
  • August 30 2016

On August 26, 2016, the U.S. Government Accountability Office (GAO) issued a report on drug coupon discount programs for privately insured patients