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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 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 finalized guidance yesterday on suspect products and notification, describing when to file a report, and added example scenarios of fraudulent activity that would warrant alerting the agency, trading partners and wholesale distributors. Read More