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.
Lexology logo
  Request new password

Search results

Order by most recent / most popular / relevance

Results: 1-5 of 5

Recent rules and guidelines

  • Drinker Biddle & Reath LLP
  • -
  • USA
  • -
  • November 30 2009

On 12 August 2009, FDA published two rules that seek to clarify the methods available to seriously ill patients interested in gaining access to investigational drugs and biologics when they are not eligible to participate in a clinical trial and don’t have other satisfactory treatment options

US & FDA developments

  • Drinker Biddle & Reath LLP
  • -
  • USA
  • -
  • November 30 2009

CDRH has moved to the FDA White Oak Campus in Silver Spring, Maryland (located at 10903 New Hampshire Avenue, Silver Spring, MD 20993

US & FDA developments

  • Drinker Biddle & Reath LLP
  • -
  • USA
  • -
  • August 7 2009

The Center for Devices and Radiological Health (CDRH) has moved to the FDA White Oak Campus in Silver Spring, Maryland (located at 10903 New Hampshire Avenue, Silver Spring, MD 20993

IPAC-RS regulatory requirements and performance requirements toolkits

  • Drinker Biddle & Reath LLP
  • -
  • USA
  • -
  • April 20 2010

The IPAC-RS Supplier Quality Working Group has developed two toolkits for suppliers and orally inhaled nasal drug products (OINDP) manufacturers

DBR Reg Sci April-September 2010

  • Drinker Biddle & Reath LLP
  • -
  • USA
  • -
  • September 23 2010

On 2 September 2010 FDA's Office of Device Evaluation released its annual performance report for the 2009 fiscal year