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Results: 11-17 of 17

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

Use of a centralized institutional review board

  • Alston & Bird LLP
  • -
  • USA
  • -
  • August 31 2010

On April 30, 2010, the Office for Human Research Protections (OHRP) published a letter responding to a medical center's question regarding the use of a central institutional review board (IRB

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