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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
Drugmakers in the EU must create a program to assess the effectiveness of their risk minimization efforts for each marketed drug, EU regulators say. Read More
The FDA and the European Medicines Agency (EMA) have completed their analysis of study data on incretin-based type 2 diabetes drugs and conclude they do not increase the risk for pancreatitis or pancreatic cancer. Read More
Endo Pharmaceuticals has entered into a five-year corporate integrity agreement with HHS to resolve marketing violations surrounding the Lidoderm patch, a popular painkiller. Read More
The FDA says sponsors of antiretroviral drugs should submit clinical trial data sets that include patient data, endpoint data, genotypic data and phenotypic data when reporting data on HIV-1 resistance to the agency in support of an HIV drug. Read More