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Results: 11-19 of 19

Examination of the medical countermeasures enterprise: FDA's initiatives to speed development of medical countermeasures
  • Alston & Bird LLP
  • USA
  • August 31 2010

The U.S. Department of Health and Human Services (HHS) recently released a report on its examination


Off-label investigations and their progeny
  • Alston & Bird LLP
  • USA
  • August 31 2010

There continues to be a focus by the government on investigating and bringing cases based on off-label promotion for both drugs and devices


Generic drug user fee program: coming soon?
  • Alston & Bird LLP
  • USA
  • August 31 2010

On September 17, FDA will hold a public meeting to begin gathering stakeholder input on the implementation of a generic drug user fee program


Electronic device registration & listing
  • Alston & Bird LLP
  • USA
  • April 16 2010

On March 26, 2010, the FDA published a proposed rule to require electronic registration and listing through its Unified Registration and Listing System (FURLS


FDA proposes standards for major statements in DTC advertising
  • Alston & Bird LLP
  • USA
  • April 16 2010

FDA recently issued a proposed rule to implement the provision of the Food and Drug Administration Amendments Act (FDAAA) of 2007 requiring that the major statement in DTC television or radio advertisements (or ads) relating to the side effects and contraindications of an advertised prescription drug intended for use by humans be presented in a clear, conspicuous and neutral manner


Periods of note
  • Alston & Bird LLP
  • USA
  • April 16 2010

Following its recent public meeting, the Food Safety and Inspection Service (FSIS) is seeking comments on ways to improve Agency procedures for identifying product that may be positive for E. coli O157:H7


Food safety reform
  • Alston & Bird LLP
  • USA
  • April 16 2010

The Office of Inspector General (OIGHHS) recently released a report detailing its review of FDA inspections of domestic food facilities


Kim McWhorter
  • Alston & Bird LLP