Tag Archives: CDER

Shutdown Forces FDA, HHS No-Shows

Officials from the Food and Drug Administration and the National Institutes of Health were scheduled to explain developments in clinical trial registration and transparency at the Drug Information Association’s conference on Clinical Trial Disclosure in Bethesda, Md. this week. They sent in slides, and one HHS official even pre-recorded his presentation. But the government shutdown […]
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FDA, CDER Weigh Organizational Changes

FDA commissioner Margaret Hamburg has formed a top-level working group to propose strategies for enhancing agency functions and processes, starting with the relationship between FDA Centers and its field force. The Program Alignment Group (PAG), announced Sept. 6, 2013, will seek to clarify the roles and responsibilities of product centers and the Office of Regulatory […]
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Biopharma Innovation in Trouble?

Next year it will cost $2.2 million to submit an NDA or biologics license application (BLA) for FDA review, and $1 million for a supplement with clinical data, generally to support new indications or expanded labeling. Review of a new biosimilar application that carries clinical data will be just as costly. While a $2 million […]
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Better Safe than Sorry: Assessing Suicide Risk in Clinical Trials

With the FDA striving to avoid post-market reactions to drugs with worrisome side-effect profiles, preventive measures that screen for obvious risks such as suicidal behavior and abuse potential are making their way into the lexicon of regulators and drug developers alike, in tandem with its mandate that stresses safety first and efficacy a close second. […]
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Woodcock Urges Forward March Toward Personalized Medicine

New approaches for conducting clinical trials and developing therapies that actually prevent and cure disease are key to the future of effective drug therapy, according to Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER). Personalized medicine has achieved mainstream status, accounting for more new drug approvals and promising pipeline candidates, […]
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