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Results: 11-20 of 80

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 report on agency transparency with regulated industry

  • Reed Smith LLP
  • -
  • USA
  • -
  • January 13 2011

The FDA is seeking comments on a report entitled "FDA Transparency Initiative: Improving Transparency to Regulated Industry."

FDA seeks comments on draft guidance addressing human clinical studies that do not require an IND

  • Reed Smith LLP
  • -
  • USA
  • -
  • October 28 2010

FDA seeks comments on the agency's draft guidance document entitled ''Investigational New Drug Applications (INDs)Determining Whether Human Research Studies Can Be Conducted Without an IND."

Use of Bayesian statistics in medical device clinical trials

  • Reed Smith LLP
  • -
  • USA
  • -
  • February 12 2010

In an effort to better streamline medical device clinical trials, FDA issued a guidance document that addresses the use of Bayesian methods in medical device clinical trials

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 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's CDER requests comments on plan for development of data standards

  • Reed Smith LLP
  • -
  • USA
  • -
  • June 18 2010

FDA is requesting comments on a draft document entitled ‘‘CDER Data Standards Plan Version 1.0,” which outlines the agency’s approach to establishing a comprehensive data standards program within the Center for Drug Evaluation and Research (CDER

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 guidance on bioequivalence study design for specific products

  • Reed Smith LLP
  • -
  • USA
  • -
  • June 18 2010

FDA has issued a guidance document entitled "Bioequivalence Recommendations for Specific Products," which announces that FDA will make available recommendations on study design for particular products on the agency's website

FDA guidance intended to bolster vaccine development

  • Reed Smith LLP
  • -
  • USA
  • -
  • March 15 2010

FDA has issued a final guidance entitled "Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications."