Sentence examples for drug authorization from inspiring English sources

Exact(2)

Rather, it is indicated that when animal-based research exists its results should be included in applications for drug authorization.

Given the fact that the safety profile of newly authorized products is not well established, a carefully designed pharmacovigilance program is particularly important at the early stages of drug authorization [ 22].

Similar(58)

The FDA requires the source data to be saved for at least 2 years after the last drug market authorization; however, local regulations may impose extended time, and the sites should comply with whichever is longer.

In the United States, F-MISO has Investigational New Drug (IND) authorization from the Food and Drug Administration FDAas an an investigational product for use in humans.

Among these, F-fluoromisonidazole (F-MISO) is the most extensively studied, and it has an investigational new drug (IND) authorization from the Food and Drug Administration FDAas an an investigational product for use in humans.

He is Member of the French Commission of drugs' distribution authorization, President of the Commission of gene and cellular therapy and President of the pharmaceutical working group on biological and biothechnological drugs.

Eliminating scientifically justified flexibility in drug development and authorization, although well intentioned, may not produce good results for patients and health-care systems.

These externally imposed constraints may take the form of formularies for prescription drugs or prior authorization by the insurer for specific procedures – e.g., expensive imaging or elective surgery – before the insurer agrees to pay for the procedures.

"They didn't want anyone crossing drugs without their authorization".

Among the most disturbing allegations against privately operated shelters publicized last week by a Reveal and Texas Tribune investigation was the charge that the Office of Refugee Resettlement "routinely administers children psychotropic drugs without lawful authorization," according to court filings.

The Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium (PROTECT) program and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) project both aim to strengthen capacity for post-authorization drug safety research.

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