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Results: 11-20 of 80

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FDA publishes draft guidance on reprocessing of reusable medical devices

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

The FDA has released for public comment a draft guidance document entitled "ProcessingReprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."

FDA issues draft guidance document on manufacturer communications to health care providers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FDA has released for comment a draft guidance document entitled, "Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information."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 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FDA seeks comments on draft guidance addressing human clinical studies that do not require an IND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FDA seeks comments on the agency's draft guidance document entitled ''Investigational New Drug Applications (INDs)Determining Whether Human Research Studies Can Be Conducted Without an IND."

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 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 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