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.
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.
To conduct this review, GAO examined FDA's actions prior to the May 6, 2004, not-approvable letter for the initial application.
Food and Drug Administration (FDA) not-approvable letter for the LuViva([R]) Advanced Cervical Scan, which the Company received in January.
On October 20, 2003, POZEN announced that it had received a not-approvable letter from the U.
Food and Drug Administration (FDA) issued a not-approvable letter on Friday, May 28, 2004 concerning the New Drug Application (NDA) for MT 100(TM) for the acute treatment of migraine.
Xcel) announced today that POZEN received a not-approvable letter from the U.
NASDAQ:CRIS) today reported an announcement from Stryker Corporation in which Stryker reported that it received a Not-Approvable Letter from the U.
After receipt of the not-approvable letter, the Company announced on January 21, 1999 its decision to discontinue funding of all of its pre-clinical development programs and has significantly reduced its workforce from earlier staffing levels.