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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
Sponsors of clinical trials in India must begin reporting all deaths that occur “in clinical trials,” under final guidance issued March 3 by the Central Drugs Standard Control Organization. Read More
The FDA wants to expand the use of biomarkers to speed up drug development and is asking for feedback on ones that have the most promise of benefiting drugmakers in the near term. Read More