Sentence examples for original approvals from inspiring English sources

One study focused on the overuse of the expedited options for innovative drugs, while the other focused on problems with drugs being quickly approved for "supplemental" uses not included in their original approvals.

Numerous lower court decisions say such supplements have the same legal status as the original approvals, even though they often receive cursory F.D.A. review and are approved in a matter of weeks.

5 6 In 2014 the FDA approved 40 new supplemental indications for already marketed drugs, compared with original approvals of 44 novel small molecule and biologic agents during the same period.

Dubock says the trial was moved because of a measles outbreak in Zhejiang, but says the original approvals were valid in Hunan as well, because the study design remained the same.

Drugs granted orphan drug designation at the time of original approval were subsequently approved for 77 supplemental indications, 40 (52%) of which were indications not related to rare diseases.

The study has been approved by the Ethics Committee of the University of Regensburg (original approval: December 2013, approval of an amendment: June 2014; file number 13-101-0262) anecessarycessary) by Ethics Committees of the participating study centers.

The study has been approved by the ethic committee of the University of Regensburg (original approval: December 2013, approval of an amendment: June 2014; file number 13-101-0262) and by ethic committees of participating study centres.

Last year, the European Court of First Instance annulled the commission's original approval of the merger after an appeal by Impala.

Several months after the original approval of a Fastow partnership, Mr. Fastow appeared before the board's finance committee to seek approval for a second, much larger partnership.

Before Tysabri's original approval, clinical trials suggested it could prevent relapses of multiple sclerosis about twice as effectively as other drugs.

Hunt's department said the court's decision was a "technical, administrative matter" and that the original approval would be reconsidered to remove any doubt over its validity.