FDA Extends Deadline For Continuous Marketing Application Pilot 2 Again
This article was originally published in The Pink Sheet Daily
Executive Summary
The agency is accepting applications for the fast-track IND pilot program until Dec. 31. Applications will only be accepted by those divisions of the drug and biologics centers that have not previously selected a Pilot 2 application.
|
The deadline for FDA's continuous marketing application Pilot 2 program is Dec. 31 following the agency's second deadline extension. "Applications will be accepted only in CDER and CBER divisions that have not previously selected a Pilot 2 application," the agency's notice of the deadline extension states. The notice is slated to appear in the Nov. 19 Federal Register. FDA has extended the deadline for Pilot 2 applications once before. The original deadline was Dec. 8, 2003; FDA later said it would accept applications between Feb. 9 and Sept. 30, 2004. The Center for Drug Evaluation & Research has enrolled at least eight INDs out of a total of 16 allowed in Pilot 2. Neurochem's amyloid A amyloidosis treatment Fibrillex was accepted by the cardio-renal division in early July (1 (Also see "FDA Cardio-Renal Division Accepts Neurochem’s Fibrillex For Pilot 2 Program" - Pink Sheet, 7 Jul, 2004.)). The pilot program, which began in October 2003, allows sponsors of fast-track products to engage in frequent scientific feedback and interactions during the IND phase of development. Only one product per review division is accepted. The Center for Biologics Evaluation & Research has a total of four divisions that can accept investigational products into the program. A separate Pilot 1 program, initiated concurrently with Pilot 2, allows sponsors to submit NDAs and BLAs in reviewable units prior to complete submission (2 (Also see "Pfizer/Eyetech Macugen Filing Complete; NDA Is Part Of FDA’s “Pilot 1”" - Pink Sheet, 17 Jun, 2004.)). - Lee Szilagyi |