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Drugmakers may soon have to report to the FDA how they decide when to launch a corrective or preventive action (CAPA) investigation, if they have a performance index for their product’s critical quality attributes and the seniority level of the employee who signs off on the annual product review. Read More
Injectable sterile drug manufacturer Pharmaceutics International received a Form 483 for its failure to adequately investigate particulates in products and conducting design inputs for its combination product. Read More
Agila Specialties failed to conduct complete investigations into customer complaints, forcing the FDA to give the Indian manufacturer with a Form 483. Read More
Identical results on different batch tests and other data integrity problems resulted in a Form 483 for Chinese active pharmaceutical ingredient (API) manufacturer Changzhou Qianhong Bio-pharma. Read More
India’s national drugs authority is again surveying pharmacists and testing drug samples in an effort to better grasp the extent of the country’s counterfeit and substandard drugs problem. Read More
Starting early next year, manufacturers will learn faster whether their drug applications have serious quality deficiencies under a sweeping reorganization of CDER’s quality functions into a new “super office.” Read More
The FDA unveiled a broad plan that will change the way it inspects drugmakers, approves recalls, issues and reviews enforcement decisions, screens imports and tests products for quality, with drugmakers likely to start feeling the impact by the end of 2015. Read More
FDA investigators will be able to photograph most areas of a facility during an inspection, including product labels and visible contamination of materials, according to a final guidance issued last month. Read More
To make it easier for generics firms to create versions of complex drugs, the FDA is asking industry to identify drug products it would like to see bioequivalence testing guidances written for. Read More
The National Institutes of Health has launched a website that it says should help drugmakers plan and implement clinical research across the globe. Read More