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Results: 11-20 of 82

Memorandum of understanding between FDA and CMS
  • Reed Smith LLP
  • USA
  • August 13 2010

The FDA and CMS have entered into a Memorandum of Understanding (MOU), effective June 25, 2010, to promote collaboration and enhance knowledge and efficiency by sharing information and expertise


FDA guidance on label comprehension studies for over-the-counter (OTC) drugs
  • Reed Smith LLP
  • USA
  • August 13 2010

FDA has issued a guidance document entitled "Label Comprehension Studies for Nonprescription Drug Products" to provide recommendations to industry on conducting label comprehension studies for OTC drug products


FDA issues Second Annual Report on sponsor compliance with postmarketing requirements
  • Reed Smith LLP
  • USA
  • November 15 2010

The Food and Drug Administration (FDA) has released a report entitled "Final Report on the Postmarketing RequirementPostmarketing Commitment Backlog Review" (Second Annual Report


FDA reopens comment periods on generic drug user fee program, PDUFA reauthorization
  • Reed Smith LLP
  • USA
  • November 15 2010

FDA has extended its comment period its August 9, 2010 generic drug user fee program notice from October 17, 2010 to December 6, 2010


FDA public workshop on clinical trials involving cell or gene therapy in pediatric populations (Nov. 2)
  • Reed Smith LLP
  • USA
  • September 17 2010

FDA will hold a public workshop on November 2, 2010 to seek input on best practices related to cell and gene therapy clinical trials in pediatric populations


FDA proposes changes to the 510(k) program; seeks public comment
  • Reed Smith LLP
  • USA
  • August 13 2010

FDA has made available for comment two reports from internal agency workgroups, one from the Center for Devices and Radiological Health (CDRH) 510(k) Working Group, and another from the Task Force on the Utilization of Science in Regulatory Decision Making


FDA withdraws direct final rule requiring the submission of information on pediatric uses of devices
  • Reed Smith LLP
  • USA
  • August 13 2010

As Reed Smith previously reported, FDA issued a direct final rule and a corresponding proposed rule requiring sponsors of premarket approval applications (PMA), humanitarian device exemptions (HDE), and product development protocols (PDP) to submit data on pediatric populations for which the device is intended to treat diagnose, or cure, and the number of affected pediatric patients


FDA issues advanced notice of new GLP rules for non-clinical studies
  • Reed Smith LLP
  • USA
  • January 13 2011

Following a workgroup's conclusion that non-clinical studies should be conducted under a good laboratory practices (GLPs) quality system approach, FDA has decided to modify the existing GLP regulations for non-clinical studies


FDA meeting on tracing and tracking prescription drugs Ffeb. 15-16)
  • Reed Smith LLP
  • USA
  • January 13 2011

FDA will hold a public workshop entitled "Determination of System Attributes for the Tracking and Tracing of Prescription Drugs" on February 15-16, 2011


FDA draft guidance on co-development of novel combination drugs
  • Reed Smith LLP
  • USA
  • January 13 2011

The FDA has released for public comment a draft guidance document entitled "Co-development of Two or More Unmarketed Investigational Drugs for Use in Combination."