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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
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
CDER’s Office of Manufacturing Quality issued 45 warning letters through Sept. 1 of this year, not counting actions against compounders, according to Francis Godwin, a division director in OMQ. Read More
The FDA will move to close a loophole in the program to foster study of treatments for rare pediatric illnesses, agency commissioner Scott Gottlieb said in a blog post. Read More