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Results: 11-20 of 82

FDA seeks comments on draft guidance concerning drug development tools
  • Reed Smith LLP
  • USA
  • October 28 2010

The Food and Drug Administration (FDA) has issued for public comment a draft guidance entitled "Qualification Process for Drug Development Tools."


GAO issues two reports examining FDA foreign inspection issues
  • Reed Smith LLP
  • USA
  • October 28 2010

The Government Accountability Office (GAO) has issued two reports addressing foreign FDA inspectional issues


FDA issues draft guidance document on manufacturer communications to health care providers
  • Reed Smith LLP
  • USA
  • November 29 2010

FDA has released for comment a draft guidance document entitled, "Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information."


FDA draft guidance on electronic source documents in clinical trials
  • Reed Smith LLP
  • USA
  • January 13 2011

FDA has published a draft guidance entitled "Electronic Source Documentation in Clinical Investigations."


FDA meeting and request for comments on generic drug user fee program
  • Reed Smith LLP
  • USA
  • August 13 2010

FDA will hold a public meeting on September 17, 2010 to seek input on the development of a generic drug user fee program


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 publishes final rule on constituent materials in biologics
  • Reed Smith LLP
  • USA
  • April 28 2011

The Food and Drug Administration (FDA) has published a final rule entitled "Revision of the Requirements for Constituent Materials."


FDA final guidance documents on writing requests for product designation
  • Reed Smith LLP
  • USA
  • April 28 2011

The FDA has released final "Guidance for Industry on How to Write a Request for Designation."


FDA issues guidance on manufacturing methodprocess changes
  • Reed Smith LLP
  • USA
  • April 28 2011

FDA has released a guidance document entitled "30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes."


Nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals
  • Reed Smith LLP
  • USA
  • February 12 2010

FDA recently issued a revision of an International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidance document, M3(R2), that was published in 1997 and is intended to harmonize and recommend international standards for non-clinical safety studies conducted to support human clinical trials of a given scope and duration, andor to be relied upon for marketing authorization for pharmaceuticals