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The FDA’s rules for clinical investigators cover a lot of ground, from how to avoid financial conflicts of interest, to delegating investigator authority to other members of the trial team, to hiring—and sometimes firing—investigators under your charge. The FDA provides all the GCP regulations and guidance documents you need to run a clinical trial, but even those documents can’t answer every question you may have about the people who actually conduct the trial. Read More
The FDA opened the doors to a dramatic new method for treating cancer — the genetic modification of a patient’s immune cells to fight the disease — by granting approval to Novartis’ Kymriah. Read More
An FDA advisory committee voted 12-to-1 against recommending approval of Janssen’s Plivensia (sirukumab) in treating rheumatoid arthritis, saying its safety profile raised too many concerns. Read More
A bill reauthorizing the FDA’s user fee agreements for the next five years and restructuring fees for biosimilars, including the first year of clinical trials, became law Aug.18 when President Trump signed it. Read More
The FDA revised its near-decade-old guidance on developing generic versions of digoxin tablets, calling for more robust testing. The agency reconsidered the guidance in response to a citizen petition from reference holder Concordia Pharmaceuticals. Read More
A federal court invalidated five Mallinckrodt Pharmaceuticals patents on its Inomax respiratory treatment system in response to the company’s own lawsuit against Praxair. Read More
Drug sponsors should ask themselves three data integrity questions before the FDA can, according to John Avellanet, managing director and principal consultant at Cerulean Associates, during an expert panel at the RAPS’ 2017 Regulatory Convergence meeting. Read More