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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
When given the opportunity to use real-world data for drug approvals, sponsors scramble to conceive innovative approaches, an EMA official said. Read More
The Office of Generic Drugs has taken action on more than 90 percent of its backlog of ANDAs and prior approval supplements, more than 15 months ahead of schedule, CDER Director Janet Woodcock announced Monday. 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