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To ensure consistency, CDER has established procedures and policies for staff to receive clearance to participate in public-private partnerships. Read More
The European Medicines Agency made several changes to a March guidance explaining the agency’s policy for publishing sponsors’ clinical trials data, including factors that could lead to rejection. Read More
The EMA has released guidance on the first steps it will take to prepare drug sponsors to comply with new data standards for the unique identification of drugs set to take effect in 2018. Read More
The FDA issued Spanish API maker Interquim a warning letter for failing to establish adequate cleaning procedures and maintain quality records data in violation of GMP standards. Read More
Fifteen FDA officials, including Commissioner Robert Califf, called for broader uses of research methodologies, such as intervention and randomization, in real-world settings outside the typical venues of clinical trials. Read More
The U.S. solicitor general has urged the Supreme Court to review a Federal Circuit decision that requires biosimilar makers wait six months after receiving FDA approval to launch a product. Read More