Giving final approval to a drug carries significant legal risks, essentially certifying that the medicine meets FDA standards ...
A plan to slash drug review times at the Food and Drug Administration is sparking deep concerns among agency staffers and ...
More than half a dozen major drugmakers are participating in the Trump administration's speedier review program for new medicines, yet other leading pharmaceutical companies are hesitating over what ...
At a STAT event, veteran drug regulator Richard Pazdur, who left the FDA last month after 26 years, said that politics and ...
1don MSN
Legal questions swirl around FDA’s new expedited drug program, including who should sign off
A plan to slash Food and Drug Administration drug review times is raising alarms at the public health agency that's been ...
The Senate’s health committee convened its first hearing of the year on the efficacy of the chemical abortion drug ...
The FDA has updated guidance outlining how it applies regulatory flexibility to chemistry, manufacturing and control requirements for cell and gene therapies. The agency said the approach is meant to ...
19hOpinion
FDA experiments with America’s children
The U.S. Food and Drug Administration may soon convert an entire generation of U.S. children, especially children in foster ...
A few recent examples of the FDA’s approach to drugs show how bad the agency’s risk aversion has become. The FDA has ...
A Lehigh County judge on Thursday rejected a request from the district attorney’s office to bypass preliminary hearings for ...
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