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The Yangzhou Hengyuan Daily Chemical Plastic Co. received a warning letter after the FDA found that one of its drugs was missing the active ingredient and that the company was not testing finished batches of drug products. Read More
The European Medicines Agency is encouraging global regulators to collaborate on life science initiatives after a review of international projects found that several countries pursue common goals without sharing resources or information. Read More
The French National Agency for Medicines and Health Products Safety (ANSM) released a statement alleging serious violations of good manufacturing practices at Nandu Chemicals Industries, an India-based API maker. Read More
The FDA’s new Inspection Protocol Project is expected to increase the likelihood of a drug manufacturing facility undergoing a pre-approval inspection from the current 30 percent to a target of 50 percent. Read More
The FDA is planning studies on whether drugmakers are effectively conveying the risks associated with a drug when benefit claims about the drug are made online in character-space-limited communications. Read More
The FDA’s Office of Prescription Drug Promotion is ordering Supernus Pharmaceutical to stop making misleading claims about the use and risks of Oxtellar XR. Read More
An FDA advisory committee has narrowly backed the approval of Cempra’s antibiotic Solithera for the treatment of community-acquired bacterial pneumonia, despite raising concerns about the candidate’s safety profile and study sample size. Read More