After almost two years of anticipation, Janet Woodcock, director of the Center for Drug Evaluation and Research, has administration approval for organizational changes to bolster programs and policies ...

Add Yahoo as a preferred source to see more of our stories on Google. The US Food and Drug Administration (FDA) has a new chief drug regulator, with industry veteran Dr Richard Pazdur taking the helm ...

Health authorities in the U.S. are continuing their move away from animal testing in drug development, with the FDA signaling ...

One surprising consequence of the coronavirus pandemic and its work-from-home zeitgeist? Biopharma companies have been compelled to rethink and perhaps even improve how they operate their businesses.

This story was originally published on PharmaVoice. To receive daily news and insights, subscribe to our free daily PharmaVoice newsletter. Dr. George Tidmarsh doesn’t have an established track record ...

Tracy Beth Hoeg has been appointed as the FDA's new CDER lead The US Food and Drug Administration (FDA) has selected Tracy Beth Høeg as its new head of drug research and evaluation – marking another ...

In January 2024, the Office of Compliance at the FDA’s Center for Drug Evaluation Research (CDER) released its Annual Report for FY2023. The Annual Report contains several useful pieces of information ...

FDA’s Center for Drug Evaluation and Research makes plans for implementation of the 21st Century Cures Act that include patient-focused drug development. Janet Woodcock, director of FDA’s Center for ...

Drug development for rare diseases can be challenging for a number of reasons, including clinical trial design challenges, clinical trial recruitment, interpretation of clinical trial data in view of ...

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has announced the launch of a new hub focused on promoting innovation in clinical trials. The CDER outlined ...