Según creo, donde vamos a saber en cualquier momento, desde hoy hasta fecha 31 Marzo como maximo, si nos permiten extender la etiqueta de la indicación MARINE con los excelentes datos del estudio ANCHOR, nos aprueban ANCHOR o nos deniegan absolutamente todo con solemne rotundidad y alevosia ..... no??
Pero no veo esa fecha en ninguna parte salvo tu foto ...
AMRN
1. What is PDUFA?
The Prescription Drug User Fee Act (PDUFA), authorizes FDA to collect fees from companies that produce certain human drug and biological products. PDUFA established three types of user fees - application fees, establishment fees, and product fees.
2. What is a human drug application?
PDUFA levies a user fee on certain human drug applications. Under PDUFA, the term human drug application means an application for
- approval of a new drug submitted under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) after September 1, 1992
- approval of a new drug submitted under section 505(b)(2) of the FD&C Act after September 30, 1992, which requests approval of
- a molecular entity which is an active ingredient (including any salt or ester of an active ingredient), or
- an indication for a use that had not been approved under an application submitted under section 505(b), or
- licensure of certain biological products under section 351 of the Public Health Service Act (PHS Act) submitted after September 1, 1992
5. What is a supplement?
The Federal Food, Drug, and Cosmetic Act (FD&C Act) says, "The term supplement means a request to the Secretary to approve a change in a human drug application which has been approved." Each indication or claim is considered a separate change for which a separate supplement should be submitted. This policy allows FDA to approve each indication or claim as it is ready for approval rather than delaying approval until the last of a group of indications or claims is ready to be approved.
