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The committee members are pressing the FDA to expand the warnings on extended-release opioids to include immediate-release versions of the painkillers. Read More
The FDA wants drugmakers to assess the risks of active pharmaceutical ingredients taken by men on the development of embryos and fetuses of their female partners. Read More
Drugmakers under consent decrees with the FDA may be able to deduct some payments made as part of their settlement with the agency when they file their tax returns, according to an informal opinion by the Internal Revenue Service’s chief counsel. Read More
Merck and Samsung Bioepis said Wednesday that their biosimilars for Enbrel and Remicade both met primary endpoints in pivotal Phase 3 clinical trials, putting them on the path to filing regulatory submissions. Read More
Drugmakers are getting better at reporting clinical trials results in a timely manner, with only 10 percent of studies on new treatments approved by the European Medicines Agency in 2012 not disclosed within 12 months, a new study shows. Read More
The FDA issued Rockville, Md.-based CXL-USA a warning letter for failing to get agency approval before starting a clinical trial and for lax monitoring of the study. Read More
CRO Analytics and the Association of Clinical Research Professionals are partnering to develop a more holistic approach to clinical trial site quality. Read More
Sponsors seeking EU authorization to market fixed-dose drug combinations should conduct multiarm, randomized, controlled trials comparing the FDC with its individual components, the European Medicines Agency says. Read More
Sponsors looking to determine whether their drugs have impurities that might lead to cancer-causing mutations in human DNA should conduct two toxicology assessments using mathematical models that base this probability on the drug’s chemical structure. Read More
The FDA wants sponsors of investigational drugs and biologics to use the Logical Observation Identifiers Names and Codes to identify laboratory results from clinical studies in regulatory submissions, and is asking for suggestions on how it might assist firms in adopting the codes. Read More