FDA Advisory Committee Action for 2012

As 2011 ended, there was a great deal of looking back at events of the year.  As it affected new medical products, FierceBiotech reported on Friday that drug approvals during the year increased to 30 last year.

Now as we edge into 2012, it is also a good time to look forward by perhaps taking stock of where the action may be in terms of candidates for approvals in the coming year.  One indicator, though not perfect, is an examination of the tentative meetings scheduled for advisory committees to meet.

Here is what we see when we look at committees for drugs, biologics and devices.

Drugs

  • There are 20 different meetings scheduled accounting for 31 days of meetings;
  • There are a dozen committees that have scheduled meetings
  • These include Allergenic Products, Anesthetic and Analgesic, Anti-Viral, Arthritis, Cardiovascular and Renal, Dermatologic and Ophthalmic, Endocrinologic, Gastrointestinal, Oncologic, Pharmaceutical Science, Pulmonary-Allergy and Reproductive Health.
  • Of these Oncologic has the most meetings and days scheduled with 7 tentatively scheduled for a total of 14 days.  Endocrinologic has 2 meetings scheduled for 3 days and Reproductive Health has 2 meetings scheduled for 2 days.  The rest all  only have one meeting slated.

Biologics

  • There are a total of 12 meetings scheduled covering 22 days;
  • Three of the committees have scheduled meetings;
  • Blood Products has scheduled 4 meetings covering 7 days;
  • Cellular Tissues has scheduled 4 meetings covering 7 days;
  • Vaccines and Related Biologics has 4 meetings scheduled covering 8 days.

Devices

  • There are 16 meetings scheduled for devices covering 23 days;
  • Anesthesiology, Clinical Chemistry, Gastro-Urology, General Hospital and Personal Use, General and Plastic Surgery, Hematology and Pathology, Molecular and CI Genetics, Obstetrics and Gynecology, Ophthalmic, Orthopedic and Rehabilitation, and Radiological Devices have all scheduled meetings;
  • The only committees having multiple meetings scheduled are Anesthesiology, Clinical Chemistry and Toxicology and Orthopedic and Rehabilitation.


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