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Drugmakers should notify the FDA and any affected trading partner within 24 hours of encountering suspected counterfeit products to prevent or limit them from entering or being distributed in the supply chain, the agency says in a notice published in the Federal Register. Read More
The FDA issued a warning letter to Coram Healthcare over its Crownpoint, Ind., facility for serious deficiencies in producing sterile drug products. Read More
Despite industry concerns that ICH’s proposed new limits on metals are too strict, the organization released final guidance on elemental impurities in finished drugs that appears little changed from an earlier draft. Read More
Merck is recalling thousands of bottles of Temodar and temozolomide capsules, because cracks in the caps have rendered the child-resistant closure ineffective. Read More
The goal of the FDA’s quality metrics program is to share quantitative data with global regulators about the state of manufacturing quality, CDER Director Janet Woodcock said. Read More
Industry is asking the FDA to clarify when immediate-release tablets should be tested using disintegration rather than dissolution and how its draft guidance on dissolution testing meshes with other agency recommendations. Read More