Significados de drug approval en inglés

The road to drug approval is rarely a short or smooth one.

Main outcomes and measures: ODAC recommendation for drug approval and subsequent FDA approval.

A drug approval decision can make or break a small company.

It could shave years off the traditional drug approval process.

It was the second controversial drug approval for Sarepta.

Participants were given background information about antibiotic resistance, streamlined drug development programmes and FDA drug approval processes.

This is likely due to differences between patient populations treated immediately after drug approval and those treated later.

Conclusions and relevance: Availability of multiple trials is associated with higher odds of ODAC recommendation and drug approval.

He cited supportive government policies, less cumbersome drug approval procedures, and an influx of capital into the healthcare sector.

Healthcare stocks were the only bright spot in the market after a U.S. Supreme Court hearing and a cancer drug approval.

However, drug approval and health technology assessment agencies have stressed that surrogates should only be used in the absence of clinical endpoints.

The studies were so-called observational studies and not the gold standard of randomly-controlled clinical trials typically used to win new drug approval.

Guardant360 is used for a range of applications, including translational science research and identifying target patient populations, drug development and commercialization post- drug approval.

Over the past year, these striking data led to major changes in advanced MCC therapy, including the first-ever FDA drug approval for this disease.

Phase III is the final stage of testing on patients before an application can be made for drug approval by the Food and Drugs Administration.

In their appeal, the Justice Department argues that the order "interferes with and thereby undermines the regulatory procedures governing the FDA's drug approval process."