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 next phase of the project will continue to reduce approval time for the clearing of shipments, in line with new global trends and the latest developments regarding the trade of hazardous chemicals, nuclear related dual use items and radioactive material, he added.
Home Credit, which has recently shortened its approval time to a minute, is now focused on reshaping the shopping landscape for everyone by providing them with more financial products and a better, easier experience.
The AIIB's decision to invest in Pakistan's bonds will save approval time which is significantly high for the government.
Work permit applications and their approval time periods vary," Mr Mufuruki said.Ms Mulinge's previous role at Safaricom was taken up by Charles Wanjohi.
"However, additional processing and approval time will occur once the Comptroller receives the vouchers, but it will be much shorter than for a bill placed in the queue."
CIMB Group Consumer Banking CEO, Samir Gupta, said: 'CIMB's instant approval process - currently the fastest in the market - is a paradigm shift in approval time for auto financing, which typically takes days.
The Environmental checklist approval time also reduced from 30 to 15 days.
Dominguez said the DOF may ask the President to once again certify the measure as urgent to cut its approval time in the bicameral committee.According to the DOF, the Package 1A and 1B of the TRAIN would help the government fund its requirements for social protection programs and massive infrastructure project.
So get your Turkey visa online by applying with us where you will have a dedicated visa expert panel that will guide you throughout the process in each and every step and then when there are less to no errors, it is evident that the visa approval time will be shorter than expected.
He made it clear that the provincial government has already adopted the practice of recruitment through NTS which should be continued in all future recruitment without obtaining approval time and again.
China Lending Group's platform provides MSMEs with flexible term loans, attractive rates, and fast turnaround loan approval time.
In 2015, Google had changed its app review process requiring apps to be verified and approved individually by actual human reviewers, without bringing the app approval time to more than a few hours on an average.