FDA’s DAARP is now DAAP, DPAP is now DPARP
- Posted by: Ken Phelps
- Published on: March 10, 2010
Effective March 15th, the FDA’s Division of Anesthesia, Analgesia, and Rheumatology Products is being reorganized. This reorganization is part of some other reassignments announced yesterday (3/09/2010) by the FDA.
The “R” part – Rheumatology, will move to the Division of Pulmonary and Allergy Products, which will be renamed the Division of Pulmonary, Allergy, and Rheumatology Products. The reviewers will move as will the applications under review. The FDA has provided a list of the IND’s and NDA’s that are affected for this DAARP to DPARP move.
The FDA announced the moves as needed to balance workload. Camargo’s experience with DAARP – we had 13 pre-IND meetings with them last year alone, indicated they did well meeting their PDUFA dates while under extreme pressure. One of the major initiatives at FDA, REMS is focused at many of the products reviewed by this Division. The burden of finding ways to deal with the abuse of opioids and the numerous sponsor views has also added to its workload. Presumably, the reassignment of rheumatology products will help.