action letter

action letter

A letter or official communication from the FDA to a new drug application (NDA) drug or medical device sponsor indicating their decision on an application for new drug approval.

Action Letter

A letter or official communication from the US Food & Drug Administration (FDA) to a new drug application (NDA) drug or medical device sponsor indicating their decision on an application.

action letter

A formal ruling issued by the U.S. Food and Drug Administration regarding the status of a therapeutic agent.
References in periodicals archive ?
On May 15, 2006, the Company received an action letter from the FDA stating that indiplon 5 mg and 10 mg capsules were approvable (2006 Approvable Letter).
Specifically, the risks and uncertainties the Company faces with respect to its indiplon program include, but are not limited to; risk that the Company will not be able to address issues and or requests set forth in the December 12, 2007 indiplon capsule action letter from the FDA in a timely manner if at all; risk that the Company will not be able to address issues and or requests set forth in the December 12, 2007 indiplon capsule action letter from the FDA in a manner acceptable to the FDA if at all; the risk that FDA may reject any future indiplon regulatory filings or find them incomplete or insufficient; and risk that indiplon approval and subsequent commercialization may be significantly or indefinitely delayed.
Food and Drug Administration (FDA) has communicated to the company that it will not be issuing an action letter on the NDA for Entereg[R] (alvimopan) for postoperative ileus by May 10, 2008, the scheduled PDUFA date.
We could then give you a no action letter - in essence a yellow light - which means proceed with caution," said Gottfried.
S&P/MIB futures (aka FIB) and S&P/MIB miniFutures (aka miniFIB) can be bought and sold in the USA as expressed in the no action letter from the CFTC (CFTC Letter No.
As previously announced, at the company's May 17, 2006 meeting with the FDA to discuss their February 2006 non-approvable decision and action letter regarding BDSI's new drug application for Emezine(R), the FDA indicated that they would consider the additional information being requested for Emezine(R) under the context of an SPA.
Inex Pharmaceuticals Corporation ("INEX"; TSX: IEX) announced today that United States Food and Drug Administration (FDA) provided an action letter detailing that the anticancer drug Marqibo(TM) (vincristine sulfate liposomes injection) is "not approvable" under the FDA's accelerated approval regulations based on the phase 2 clinical trial data submitted.
The FDA has acknowledged the receipt of the submission and considers it to be a complete, Class I response to the April 10, 2006 action letter.
The action letter included proposed labeling for both indications and a request for supplemental data from the existing asenapine database.
Astellas") today announced that they have received an action letter dated August 8, 2008 from the U.
Pursuant to PDUFA guidelines, Somaxon expects that the FDA will complete its review and provide an action letter to the company with respect to the NDA by December 1, 2008.
The completion of the 10b-10 No Action Letter demonstrates SSCNet's continuing improvement to its suite of services that support post-trade settlement," said Alex Marasco, Senior Vice-President, SSCNet and SVC.