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A California supplement maker is in hot water after being accused of making drug-like claims about its products and relying on improper production methods. Read More
A growing number of health insurers are asking pharmaceutical manufacturers to tie payment to how a drug performs. Some drugmakers are taking the leap into this relatively unchartered territory. Read More
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