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China has joined the ICH as its eighth regulatory member, pledging to gradually transform its pharmaceutical regulatory authorities, industry and research institutions to implement the international coalition’s technical standards and guidelines. Read More
The FDA’s Office of Pharmaceutical Quality is working to rebalance views on measuring risks versus benefits, as well as improve the effectiveness of the agency’s communications to industry and the public. Read More
An FDA advisory committee voted unanimously to recommend to the agency that a diabetic drug is not associated with excessive cardiovascular risk, and also voted 17-to-2 to recommend an added indication that it reduces heart risks in patients with type 2 diabetes. Read More
The FDA has released a new draft guidance that clarifies the Part 11 regulations for electronic records and signatures as they apply to clinical trials, including validation of mobile and wearable technology and the use of outsourcing and contracting. Read More
The FDA will clear its backlog of orphan drug designation requests in the next 90 days, Commissioner Scott Gottlieb told Senate appropriators, and the agency plans to assign a team dedicated to assessing the approximately 200 applications currently pending. Read More