We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.
In cooperation with Association of Corporate Counsel
  Request new password

Search results

Order by most recent / most popular / relevance

Results: 11-20 of 80

FDA publishes draft guidance on reprocessing of reusable medical devices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The FDA has released for public comment a draft guidance document entitled "ProcessingReprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."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 requests notices of intent to participate in periodic PDUFA reauthorization meetings

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

FDA has issued a notice to stakeholders requesting that those parties intending to participate in periodic consultation meetings on reauthorization of the Prescription Drug User Fee Act (PDUFA) notify the agency

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 and NIH announce collaboration to speed patient access to new therapies

  • Reed Smith LLP
  • -
  • USA
  • -
  • February 26 2010

FDA and the National Institutes of Health (NIH) have announced a new initiative aimed at improving efficiencies in translational science and regulatory science to close the gap in time between discovery of new technology and availability of therapies to patients

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FDA issues draft guidance document on manufacturer communications to health care providers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FDA has released for comment a draft guidance document entitled, "Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information."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