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 ?
Nektar Therapeutics disclosed earlier this morning that as of this morning, the company has not received an action letter from the FDA regarding its new drug application for NKTR-181, thereby resulting in the FDA not meeting the PDUFA goal date of August 29.
The FDA considers the Dsuvia NDA resubmission a complete class 2 response to their October 2017 action letter, and has assigned a PDUFA goal date of November 3, 2018.
In January, the Securities and Exchange Commission issued a "no action letter" widely and wrongly interpreted as legalizing the role of unregistered broker/dealers as compensated M&A finders.
The man sadly died, but Mr Pace was awarded a "commendable action letter" from the RNLI, prompting an interest in the organisation.
Monroe, NC, May 05, 2013 --(PR.com)-- FRS today introduced AdverseActTM, a powerful, integrated solution for both Consumer Reporting Agencies (CRAs) and HR Professionals to help automate and address each of their Adverse Action Letter reporting and notification requirements.
The no-action letter was the result of a lot of good discourse with the Illinois Securities department and we appreciate their efforts and are pleased with the no action letter. I think it's notable that the no-action letter does not detract from the Illinois Securities Department's authority over investment advisors, which was somewhat at the heart of the Pinnacle case.
Issuance of a confirmatory action letter does not preclude the NRC from taking other actions for any violations of NRC requirements that may be identified, the commission reported.
AEM joined other construction and business groups in an industry call to action letter last week that urged the administration to approve the pipeline, citing the important job creation opportunity and the ability for the completed pipeline to help pro vide a stable supply of North American energy to American consumers.
The Commissioner of Competition issued a "no action letter," which signals compliance with all requirements of the Competition Act, for the C$4.70 a share offer.
In addition, Ciena also has received from the Canadian Competition Bureau a no action letter, terminating the applicable waiting period for the proposed transaction under the Competition Act.
However, FDA appears to be waiting for further clarification of issues surrounding generic biologics before issuing an action letter on the NDA, which was originally filed more than two years ago.
Many appraisers feel that after a No Further Action letter is issued by a state environmental agency the responsible party and future property owners are absolved of financial responsibility for remediating the previous environmental contamination.
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