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Following tradition, FDA Commissioner Robert Califf will leave the agency on Inauguration Day, when Stephen Ostroff — deputy commissioner for foods and veterinary medicine — will temporarily assume the role. Read More
Japan’s Pharmaceutical and Medical Devices Agency is joining the ranks of the FDA, the EMA and a few other drug regulators by agreeing to participate in a program that allows the agencies to share GMP inspection plans and results for API manufacturing sites. Read More
The FDA handed Baoying County Fukang a warning letter after the company’s management withheld information from the agency and failed to maintain methods and controls in compliance with GMP standards. Read More
The FDA served drug manufacturer Japanese drugmaker Eisai a Form 483 after an inspection of its Baltimore, Maryland facility revealed recordkeeping and quality control issues that led to incomplete data and unrestricted access to computers. Read More
Amid concerns of rising pharmaceutical prices, HHS finalized a rule threatening fines against drugmakers that knowingly overcharge hospitals and providers under the 340B drug discount program. Read More