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Feb 04 2013

New FDA Guidances for January 2013

FDA has already released a handful of new guidances to start off the year 2013.  They include:

Last month, FDA also released their agenda for new and revised guidance documents to be released in 2013.  The agenda doesn’t provide specific publication dates for any of the 59 listed guidances, but at least this gives us an idea of what to look for from FDA throughout the rest of the year.

The guidances will cover 17 different categories ranging from advertising and the animal rule to pharmacology/toxicology and procedural guidances. Areas like Chemistry and Current Good Manufacturing Practices (CGMPs)/Compliance are well represented with 13 of the planned guidances.  Similarly, expect to see a number of guidances for Electronic Submissions.  Guidances of particular interest include:

  • Multiple Endpoints in Clinical Trials
  • Expedited Programs for Serious Conditions, Drugs and Biologics
  • Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants
  • Investigational New Drug Applications prepared and submitted by Clinical Sponsor Investigators.

Kimberley Cummings, Ph.D. contributed to this post.  Kimberley is the Director, Regulatory Affairs at Cato Research.