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With an eye toward improving product quality, the FDA is inviting drugmakers to join a program to evaluate emerging manufacturing technology. Read More
The FDA is asking Sun Pharmaceuticals to conduct tests and turn over reams of paperwork in response to a warning letter alleging more than a dozen cGMP violations. Read More
The FDA has issued a proposed rule harmonizing regulations for prescription and OTC fixed dose combination products, along with co-packaged drugs and combinations of active ingredients under consideration for inclusion in an OTC monograph. Read More
A House committee is asking for a review of the FDA’s progress in ensuring the security of foreign facilities’ supply chains and toughening the agency’s approach to inspections at those facilities. Read More
Another Indian drugmaker is in hot water with the FDA, with Sun Pharma’s Halol, Gujarat, facility earning a warning letter for a lack of sterility assurance and validation of the sterility system. Read More