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Drug companies can move beyond simply satisfying FDA regulations by meticulously tracking quality elements, Baxter International quality expert Kevin Cloonan said Monday at the PDA/FDA Joint Regulatory Conference in Washington, D.C. Read More
CDER’s Office of Manufacturing Quality issued 45 warning letters through Sept. 1 of this year, not counting actions against compounders, according to Francis Godwin, a division director in OMQ. Read More
CDER’s Office of Manufacturing Quality issued 45 warning letters through Sept. 1 of this year, not counting actions against compounders, according to Francis Godwin, a division director in OMQ. Read More
Drug companies can move beyond simply satisfying FDA regulations by meticulously tracking quality elements, Baxter International quality expert Kevin Cloonan said Monday at the PDA/FDA Joint Regulatory Conference in Washington, D.C. Read More
Data integrity, recordkeeping and drug trial oversight violations feature in the UK Medicines and Healthcare products Regulatory Agency’s latest report on good clinical practice inspections. Read More
Data integrity, recordkeeping and drug trial oversight violations feature in the UK Medicines and Healthcare products Regulatory Agency’s latest report on good clinical practice inspections. Read More
Unable to resolve persistent manufacturing problems, New Jersey-based drugmaker Pacira Pharmaceuticals is ending production of its DepoCyt chemotherapy drug and closing the California plant where it is made. Read More
A federal judge has barred an Alabama compounder from manufacturing, holding or distributing drugs until the facility complies with FDA regulations. Read More
A California company violated federal law by making and selling as a dietary supplement a product containing prescription drugs used to treat erectile dysfunction, the FDA said. Read More