Will the subsequent remarriage to the Filipino spouse be recognized by the US Citizenship and Immigration Services as an approvable
"While we have drafted our responses to questions in the not approvable
letter received in September, we feel it is in our best interest to meet with FDA before submission of the official response," said Gene Cartwright, CEO of Guided Therapeutics.
SURFAXIN(r), the company's lead product from its SRT pipeline, is the subject of an Approvable
Letter from the FDA for the prevention of Respiratory Distress Syndrome in premature infants.
Under new regulations that govern the drug approval process, FDA's Center for Drug Evaluation and Research (CDER) will no longer issue "approvable
" or "not approvable
" letters when a drug application is not approved.
The Food and Drug Administration will no longer issue "approvable
" or "not approvable
" letters when a drug application is not approved, but will instead issue a "complete response" letter at the end of the review period, the agency has announced.
Currently, when assessing new drug and generic drug applications, the FDA can respond to a sponsor in one of three types of letters: an "approval" letter, meaning the drug has met agency standards for safety and efficacy and can be marketed for sale in the United States; an "approvable
" letter, which generally indicates that the drug can probably be approved at a later date provided that the applicant provides certain additional information or makes specified changes (such as to the labeling); or a "not approvable
" letter, meaning the application has deficiencies generally requiring the submission of substantial additional data before approval.
The Food and Drug Administration has issued a "not approvable
" letter to Luitpold Pharmaceuticals for its ferric carboxymaltose injection (Injectafer), leaving the company to conduct additional clinical trials for the drug as first-line treatment of iron deficiency anemia in women with postpartum and heavy uterine bleeding.
In addition, the number of approvable
letters, which state what conditions must be met for a drug to be approved increased.
DOR BioPharma, Ewing, NJ, announced the company received a not approvable
letter from the FDA for its lead product orBec (oral beclomethasone dipropionate, or oral BDP) for the treatment of acute gastrointestinal Graft-Versus-Host-Disease.
Zenvia is AVANIR's lead product candidate for the treatment of involuntary emotional expression disorder (IEED) and is the subject of an approvable
letter from the FDA.
"We're seeing some progress and we're making sure each state has a fully approvable
plan in the near future," says Assistant Secretary for Elementary and Secondary Education Henry Johnson.