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When given the opportunity to use real-world data and adaptive trial designs to secure marketing authorization, drug sponsors often struggle to develop innovative approaches. 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
The FDA made strides in its quality metrics endeavors Friday, complementing a draft guidance for submitting quality metrics data with a host of technical recommendations. Read More