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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
The FDA is accusing two Chinese API manufacturers of doctoring laboratory results, with one cited for falsifying lab reports and the other for running both official and unofficial tests. Read More
The FDA handed a 10-observation Form 483 to a Texas manufacturer for sterility shortcomings, inadequate testing of products and deficient recordkeeping. Read More