approval time

approval time

An FDA (US) term for the time elapsed between the first New Drug Application (NDA) submission to NDA approval, which is the sum of FDA review time for the first submission of an NDA to the Agency, plus any subsequent time during which a pharmaceutical sponsor addresses deficiencies in the NDA and resubmits the application, plus subsequent FDA review time. 
Examples Approval actions; changes in labelling, route of administration, and patient population for a drug product.
References in periodicals archive ?
The system shortens the entire process, cutting permit approval time down to as little as three days," said Keith Melvin, director of Outdoor Advertising at SCDOT.
This customized automation and electronic storage will reduce underwriting time and physical storage needs and increase quality control while decreasing loan approval time and enabling more efficient service to the mortgage broker, and, ultimately, the borrower.
Historically, the approval time for orphan products as a group has been considerably shorter than the approval time for other drugs.
Expedited review status may lead to a reduction of the approval time for these drugs and may expedite the placement of these drugs on the market.
The rating continues to reflect Watson's strong off-patent drug portfolio, positive industry trends, including shortened Food and Drug Administration drug approval time, and solid financial performance.
Trinity has been informed by Grace Hollands and Associates, its FDA consultants handling this submission, that the expected approval time for this 510K approval will be between 70 and 120 days.
ATLANTA, April 29 /PRNewswire/ -- Banks can reduce consumer loan approval time from an average of one to two weeks to only 25 minutes by implementing automated workflow software, according to Rory McClure, a banking systems expert with Horwath Crowe Chizek, a member of Horwath International, the worldwide network of independent accounting and management consulting firms.
Meyer was recognized by the Pharmaceutical Manufacturers Association for his regulatory management contributions in 1993 which led to an average three month reduction in new drug review and approval time.
A recent Wall Street Journal article reported that 510(k) approval time has increased to an average of 170 days.
The median Abbreviated New Drug Application (ANDA) approval time is currently 42 months, meaning that it takes the FDA, on average, more than three times longer to approve an ANDA than to approve a standard New Drug Application (NDA) or Biologic License Application (BLA) and more than five times longer than it takes to approve a priority NDA/BLA.
Compared with many financial institutions, the small and micro-financiers have reduced approval time from days to minutes, says Mr Stefan Coetsee, country manager at Get Bucks Ltd, a company that offers short term loans to civil servants and those in formal employment.