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Drugmakers are being asked to partner with the NIH, academics and biotechnology companies to develop new antibiotics, under a White House plan announced late Friday. Read More
Drugmakers seeking approval of genetically engineered products must begin submitting an assessment with their applications that evaluates whether they would be harmful if released into the environment. Read More
CDER plans to increase cooperation with European counterparts and make more use of databases as sources of safety data as it hones its approach to drug safety monitoring. Read More
Manufacturers of biosimilar insulin-containing products must demonstrate pharmacodynamic and pharmacokinetic similarity profiles to prove similar efficacy to their reference insulin, the European Medicines Agency says in final guidance issued this week. Read More
The FDA needs to work with devicemakers and Congress to understand why clinical development takes longer here than in other countries and then implement changes to speed up the process, a new study concludes. Read More
The European Medicines Agency is defending its decision to redact certain clinical study reports for AbbVie’s Humira before releasing them to a researcher, setting up a test case for the EU’s new trial transparency policy. Read More
The Office of Human Research Protections’ recent proposal to classify risk-comparison trials as “greater than minimal risk” will force physicians and patients to engage in overly burdensome informed consent processes that are out of proportion to the scope of the trials themselves, a leading bioethicist says. Read More