Thus, whether his petition will be approvable
or not, will depend on whether or not his marriage to US citizen spouse Mary was done in good faith or not.
The request is a response to a "not approvable
" letter the firm received in September for its LuViva Advanced Cervical Scan.
ODE has committed to an expeditious review of the PMA amendment and agreed to issue a determination on whether the PMA is approvable
no later than 180 days after submission of the PMA amendment.
The product is USDA approvable
and is intended only for non-public health uses.
All Elastocon grades are free from latex, and are RollS and California Proposition 65 compliant, with many of the company offerings being FDA compliant, as well as UL and NSF approvable
, and are suitable for medical applications.
Such letters, known as "complete response" or "not approvable
" and refuse-to-file letters, are currently released only if and when a recipient decides to make them public.
She also said that investigations were a right of all countries, but nevertheless insulting someone in its garb was definitely not approvable
, and Pakistan would not tolerate such instance.
The FDA sent Shire an "approvable
" letter in January 2008, but in early August, the company was told by the agency that it still was not in agreement on the final labeling for the extended-release form of guanfacine.
The FDA's Circulatory System Devices Panel voted 7-5 that the Watchman device was "approvable
" as a "noninferior" treatment to long-term warfarin therapy in warfarin-eligible patients with nonvalvular atrial fibrillation (AF), for reducing the risk of stroke, cardiovascular death, or systemic embolism.
At this point, applications will fall into one of three categories--approved, approvable
(showing clinical benefit) or not approvable
Surfaxin(r), an investigational drug, is the subject of an Approvable
Letter from the FDA for the prevention of Respiratory Distress Syndrome in premature infants.
This decision was based on a list of outstanding issues received following review by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) of the filing, which indicates that the opinion of the Committee is that the application is currently not approvable
based on the information provided.