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Results: 11-20 of 80

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

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."

FDA seeks comment on transparency proposals

  • Reed Smith LLP
  • -
  • USA
  • -
  • May 25 2010

FDA is rolling out phase II of the FDA's Transparency Initiative with the issuance of 21 draft proposals intended to expand disclosure of information while maintaining confidentiality of trade secrets and individually identifiable patient information

FDA draft guidance on adaptive design clinical trials for drugs and biologics

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

FDA has issued a draft guidance document to help sponsors plan and conduct adaptive design clinical studies, and to aid agency staff in the efficient FDA review of such data

FDA’s emerging internet policy: themes and recommendations from public hearing on promotion of FDA-regulated medical products using the internet and social media tools

  • Reed Smith LLP
  • -
  • USA
  • -
  • November 27 2009

Following a decade-long hiatus, the Food and Drug Administration ("FDA") appears ready to finally address industry Internet communications

Guidance on complete submissions for the evaluation of proprietary names

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

To maximize the agency's efforts to process submissions for the evaluation of proprietary names within the deadlines under the Prescription Drug User Fee Act (PDUFA), FDA issued a guidance document to assist manufacturers in making a complete submission, which is required for the PDUFA review clock to begin

Draft guidance on assessment of abuse potential of drugs

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

FDA published a guidance document aimed at sponsors that are developing drug products with the potential for abuse that may need to be scheduled by the Drug Enforcement Agency (DEA) under the Controlled Substances Act

ICH guidance on non-clinical studies on anti-cancer pharmaceuticals

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

FDA has released a new guidance from the International Conference on Harmonization (ICH) entitled "S9 Nonclinical Evaluation for Anticancer Pharmaceuticals."

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