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The European Medicines Agency’s decision to redact certain personal and commercial information from clinical study reports before releasing them to a private citizen did not violate EU transparency policy, the European ombudsman says. Read More
California Gov. Jerry Brown (D) Sunday vetoed a bill that would have allowed drugmakers to make experimental therapies available to terminally ill patients if recommended by two doctors, saying the FDA’s compassionate use program should be given a chance to work. Read More
The FDA has reopened the comment period for draft guidance on established conditions for reporting chemical, manufacturing and control changes in NDAs, ANDAs and BLAs. Read More
The FDA is heeding industry requests to simplify the ANDA approval process by allowing generics makers to submit proposed labeling instead of final printed labeling. Read More
With a growing number of biologics set to lose patent protection in coming years, a leading industry group is calling for regulatory reforms to encourage the development and approval of biosimilars. Read More
The FDA is trying to reassure drug companies by making it clear that the agency won’t use its quality metrics collection to spur 483s, warning letters and other enforcement actions. Read More
The FDA has issued final guidance for generics makers on making formal requests for information, including on topics still under agency consideration. Read More