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 Environmental checklist approval time also reduced from 30 to 15 days.
SBCA cuts procedural time for constructions getting permit
SpherePay is looking to reduce the approval time to 10 minutes in the near future.
Singapore : SpherePay introduces Advance Credit function
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.
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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.
CM approves setting up of Restaurant of Invoice Monitoring System
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.
Google removes Afghan Taliban app from Play Store
This could potentially reduce approval time down to two or three years," Mizuta said.
Pluristem pursues development strategy in Japan
Jain added that home prices can be cut down by 20-30 per cent if the approval time is reduced to 30 days, which is entirely possible.
Parekh seeks online nod for real estate
According to the report, the minister also said the government had reduced the approval time for business licences and company registration considerably.
Malaysian govt says Indian community should not feel 'sidelined in any way'
Approval time was defined as the time between date of protocol submission and the date on the letter confirming approval.
Analysis of time to regulatory and ethical approval of SATVI TB vaccine trials in South Africa
By the end of year five of the newly established generic drug user fee program, the FDA will review and act on 90% of complete electronic Abbreviated New Drug Applications (ANDAs) within 10 months after the date of submission (the current average approval time is 31 months) and will review and act on 90% of all ANDAs and ANDA prior-approval supplements regardless of current review status pending on October 1, 2012, by the end of fiscal year 2017.
GPhA sees GDUFA as a 'major win'
Another pressing issue is approval time for biologic drugs.
Increasing clarity
Our current mortgage finance product allows potential buyers to take advantage of the low interest rate on offer along with a minimum approval time frame".
Pegasus-Standard Chartered in tie-up
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