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Results: 11-20 of 82

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FDA seeks comments on draft guidance concerning drug development tools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The Food and Drug Administration (FDA) has issued for public comment a draft guidance entitled "Qualification Process for Drug Development Tools."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 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 meeting on patient medication information for prescription drugs
  • Reed Smith LLP
  • USA
  • August 30 2010

FDA announced a two-day public hearing to be held on September 27 -28, 2010 to seek public input on a new framework for the development and distribution of patient medication information (PMI) to be provided to patients with prescription drug products


FDA draft guidance on electronic source documents in clinical trials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FDA has published a draft guidance entitled "Electronic Source Documentation in Clinical Investigations."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 guidance documents
  • Reed Smith LLP
  • USA
  • December 4 2009

FDA released a number of final and draft guidance documents in November, including the following


FDA listing of drugs with potential safety issues
  • Reed Smith LLP
  • USA
  • February 26 2010

On February 18, 2010, the FDA posted updated listings of specific drugs that are being evaluated for potential safety issues based on a review of reports in FDA's Adverse Event Reporting System


Public hearing on promotion of FDA-regulated medical products using the internet and social media tools
  • Reed Smith LLP
  • USA
  • December 4 2009

The FDA recently held a hearing to help the agency determine how the statutory provisions, regulations, and policies concerning advertising and promotional labeling should be applied to product-related information on the internet and newer technologies


FDA announces Safe Use initiative for drug products
  • Reed Smith LLP
  • USA
  • December 4 2009

The Food and Drug Administration (FDA) has announced the Safe Use Initiative, a program aimed at reducing the likelihood of preventable harm from medication use