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The FDA has underestimated the burden that would be imposed on drug manufacturers in collecting and reporting quality metrics data, industry says in comments on the agency’s quality metrics draft guidance. Read More
A Los Angeles area supplement provider has been hit with an FDA warning letter for selling unapproved drugs for conditions ranging from kidney stones to stroke prevention. Read More
Nearly a dozen organizations are calling for clarification on a draft FDA plan to label injectable therapies that are meant to be used multiple times by a single patient as products for “single patient–use.” 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 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
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