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Developers of antiviral drugs for prophylaxis and treatment of respiratory syncytial virus should expose at least 100 adults in clinical trials ahead of pediatric studies, the FDA said in new guidance for drugmakers. Read More
Rigorous patient preference information should be part of the FDA’s process to determine risks and benefits of new products, Commissioner Scott Gottlieb said in a statement coinciding with the inaugural meeting of a new advisory committee on patient engagement. Read More
Competition and consolidation tied for first place on the list along with intellectual property issues, the ability to commercialize products, and litigation. Read More
Boehringer Ingelheim suggested the FDA draft guidance on child resistant packaging labeling, published in August, could confuse consumers who may not understand why only some drug products bear the CRP statement. Prescription drugs are often repackaged by dispensers or pharmacists, running the risk of the information never reaching the consumer, Boehringer said. Read More
The FDA has revised its draft guidance on content and formatting for Risk Evaluation and Mitigation Strategy documents to highlight who is responsible for each required action, rather than just the listing the statutory elements from the Food and Drug Administration Amendments Act of 2007. Read More
A libertarian advocacy group that backs right-to-try laws pressed the FDA in federal court to release information about the agency’s “incredibly expeditious” decision to authorize the treatment of two Ebola patients with an unapproved drug. Read More