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The FDA has identified 10 quality data points that finished dosage form and active pharmaceutical ingredient makers will need to collect to calculate four quality metrics for each product they produce. Read More
Drugmakers want to know when changes to chemical, manufacturing and controls in NDAs, ANDAs and BLAs must be reported to the FDA, saying draft guidance lacks clear criteria and examples. Read More
South Carolina drugmaker Trans Ox was rapped for major deviations in good manufacturing practices and quality controls after FDA investigators found cobwebs on equipment used to analyze drug batches. Read More
The FDA wants manufacturers to better control the amount of excess drug or biologic they put in injectable vials and ampules to ensure proper patient dosing. Read More
The FDA issued a notice today clarifying that any adverse event not included on a compounded drug’s labeling should be considered “unexpected” and reported to the agency. Read More
Manufacturers of new drugs and biologics, generics and biosimilars, as well as outsourcing facilities, will pay higher user fees for their applications starting Oct. 1, according to figures released Friday by the FDA. Read More
Manufacturers of highly soluble immediate-release tablets and capsules may use standard release tests instead of method development and specification-setting exercises to show how quickly the drug dissolves, the FDA says in draft guidance released Friday. Read More
The list of states allowing substitution of biosimilars for prescription medicines nearly doubled in the first half of 2015 as seven states joined the list of eight that passed similar laws in 2013 and 2014. Read More