Sentence examples for approval applications from inspiring English sources
And last year, after federal regulators determined that one of the plants falsified data and test results, the agency stopped reviewing new or pending drug approval applications from that plant, pending corrective action by Ranbaxy.
This still holds true for all other approval applications of other GM organisms (GMOs).
Currently, the database contains information regarding about 19,226 FDA approval applications for 31,815 products (small molecules and biologics) with their approval history, 2505 active ingredients, together with as many ADMET properties, 1629 molecular structures, 2.5 million adverse effects and 36,963 experimental drug-target bioactivity data.
The exact nature of these committees and their individual requirements was found to vary considerably by Neumann (1999) when ethical approval applications were submitted to 25 committees throughout Australia for a multi centre trial into the effectiveness of physiotherapy management of stress urinary incontinence in women.
With the time to loss of virologic response (TLOVR) clinical trial end point advocated by the Food and Drug Administration FDAA) for new drug approval applications, failure is defined by two pVL measurements above the HIV RNA assay's LLOQ [12].
The PIs were responsible for the design and implementation of trials, including research governance and ethics approval applications.
Submit your Pre-market Approval application or PMA if applicable.
It said the company would await the minister's "timely reconsideration" of its approval application.
Avanir plans to present the results to the Food and Drug Administration by the end of June as part of its approval application.
Medtronic told Wall Street Sept. 12 a Food and Drug Administration panel is set to review its pre-market approval application for the Endeavor drug-eluting coronary stent.
Tumor markers may be reviewed as 510(k) submissions or as premarket approval application (PMA) submissions or may be exempt from premarket reviews.
