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 ?
The SEC guidance consisted of a No Action Letter directed to the Investment Adviser Association regarding third-party SLOAs and an amendment to an existing published FAQ regarding standing instructions for like-titled transfers.
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.
The FDA reportedly considers the company's filing a complete, class 2 response to its action letter and has set a Prescription Drug User Fee Act (PDUFA) goal date of 30 April 2013.
The Nuclear Regulatory Commission has issued a confirmatory action letter to Honeywell Metropolis Works outlining actions the company has agreed to take before restarting its uranium conversion operations in Metropolis, Ill.
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.
Southern California Edison (SCE) has submitted its response to the Nuclear Regulatory Commission's (NRC) Confirmatory Action Letter, along with its restart plan for Unit 2 of its San Onofre Nuclear Generating Station.
html) refused to issue a no action letter against a proposal to help shareholders review whether a mutual fund was voting its shares of stock in a way that reflected its stated climate change policy.
22 August 2011 - US Alexza Pharmaceuticals Inc (NASDAQ:ALXA) said today that the US Food and Drug Administration (FDA) has accepted the Adasuve New Drug Application (NDA) as a complete, class two response to the FDA's action letter, with an indicated Prescription Drug User Fee Act (PDUFA) goal date of 4 February 2012.
With all these actions completed, the DEP issued a No Further Action Letter.