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After six years of uncertainty, the FDA has lifted a clinical hold on trials of Oxygen Biotherapeutics’ Oxycyte intravenous emulsion, reviving hope for the drugmaker’s traumatic brain injury treatment. Read More
Beginning on June 16, whenever a drugmaker receives approval for a new drug by an EU member state, it will have 15 calendar days to report the approval to the EMA’s new centralized electronic registry. Read More
The White House on Tuesday proposed increasing funding for the FDA in fiscal 2015 by 8 percent above fiscal 2014, and requested that $25 million be directed towards the agency’s expanded authority to inspect compounding pharmacies. Read More
Sponsors planning on sending lot release samples to CBER in May and June should plan to delay until after the center relocates to the FDA’s White Oak headquarters in Silver Spring, Md. Read More
The FDA will create a pharma-only enforcement unit that promises more consistent inspections and enforcement decisions with fewer bureaucratic hurdles for investigators to issue warning letters. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MRHA) is reminding drugmakers they must report all defects in medicinal products that could lead to a recall immediately upon discovery and provide regular updates on internal investigations into the defects. Read More
The FDA has warned China’s CBSCHEM Limited, an active pharmaceutical ingredient (API) labeler, for ignoring fundamental quality functions such as keeping detailed records and maintaining a quality unit. Read More