not-approvable letter

not-approvable letter

An official communication from the FDA to inform a sponsor of a marketing application that the important deficiencies described in the letter preclude approval of the drug or device unless corrected.
References in periodicals archive ?
Guided Therapeutics Inc (OTCBB:GTHP)(OTCQB: GTHP), a medical technology and products company, announced on Friday that it plans to seek an independent panel review of its Pre-market Approval (PMA) application for the LuViva Advanced Cervical Scan from the US Food and Drug Administration (FDA) after receiving a not-approvable letter from the agency.
23 January 2012 - Guided Therapeutics Inc (OTCBB:GTHP) announced on Friday plans to request an independent panel review of its Pre-market Approval (PMA) application for the LuViva Advanced Cervical Scan from the US Food and Drug Administration (FDA) after receiving a not-approvable letter from the agency.
An overview of the new policy notes that some drug makers had expressed concern that a not-approvable letter "sent an unintended message that a marketing application would never be approved, which could adversely affect a company's ability to raise capital."
But because the letters are not made public, investors may get less information than they did when companies announced they had received an approvable or not-approvable letter, some analysts say.
However, he testified that he was not pressured into issuing the May 2004 not-approvable letter for making Plan B available over the counter for women of all ages.
First, the FDA staff who would normally have been responsible for signing the not-approvable letter disagreed with the decision and refused to sign.
To conduct this review, GAO examined FDA's actions prior to the May 6, 2004, not-approvable letter for the initial application.
After receiving the not-approvable letter in September, Cyberonics amended the original application to include comprehensive 1-year data and analyses on 460 patients.
Cordaptive's potential FDA approval was set aside on April 28 by a "not-approvable letter," in which the agency seeks additional data from the applicant.