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Public Citizen is calling on the FDA to add a boxed warning to a class of drugs for treating Parkinson’s disease and ADHD to address a potential link to behavioral problems. Read More
The FDA has released draft guidance on conflict of interest for advisory board participants, detailing the agency’s process for determining whether a committee member’s connections create the appearance of bias. Read More
AstraZeneca is suing the FDA in an exclusivity dispute over its anti-cholesterol drug Crestor, claiming that the agency’s interpretation of the FD&C Act unfairly subjects the drug to early generic competition. Read More