Sentence examples for data for approval from inspiring English sources

For the higher risk devices, the F.D.A. requires comprehensive clinical data for approval.

Some might have to come off the market until the developer can provide enough data for approval.

The Food and Drug Administration said it would ask the Institute of Medicine for comment on seven proposals, including creation of a new category of devices that would require more data for approval.

FDA has spent nearly 2 years coming up with guidelines for industry on how to handle pharmacogenomics data for approval decisions.

7 Moreover, clinical efficacy data for approval is less stringent for medical devices than for drugs.

In the US, the first step in the approval is the clinical assessment of the instrument to gather data for premarket approval (PMA) report and documentation.

The C.D.C. is working with the food and drug agency and with test manufacturers to gather, analyze and coordinate the submission of data for federal approval of NAATs for use in the throat and rectum.

A follow on Phase III study COG-ANBL0931 opened Jan 2010 to accrue 105 patients to gather further safety and efficacy data for FDA approval.

Perhaps the only immediate solution to this problem is to not submit early data for regulatory approval, although this delays the availability of new interventions for patients.

In no small part because of NBCC's standing as a highly credible national advocacy organization, the trials needed to generate data for Food and Drug Administration FDAapprovalval proceeded apace.

These data were sufficient for approval from the European Medicines Agency (the Epigenomics Epi proColon), but an FDA advisory panel split 5-4 on the matter in early 2014, and the FDA itself has requested further data on screening compliance before granting approval [ 101].