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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
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
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
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
- -
- 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
