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A response to a Form 483 is not a routine or informal communication and should be given the same attention and care you would give to defending your company from a federal indictment — because that’s what a 483 actually is. Read More
As a precursor to the FDA’s official implementation of a quality metrics reporting program, the agency will begin accepting voluntary data submissions from drugmakers on the quality of their finished dosage form drugs and APIs in early 2018 for a pilot run of the risk-based system. Read More
The FDA is accusing two Chinese API manufacturers of doctoring laboratory results, with one cited for falsifying lab reports and the other for running both official and unofficial tests. Read More
The time and effort to collect quality metrics dictated in an FDA draft guidance are about three times higher than the agency’s original estimates. Read More
The FDA is accusing two Chinese API manufacturers of doctoring laboratory results, with one cited for falsifying lab reports and the other for running both official and unofficial tests. Read More
Industry groups are worried that a section of the proposed FDA and NIH Workforce Authorities Modernization Act would exempt biologics from adhering to U.S. Pharmacopeial standards for quality. Read More
The time and effort to collect the quality metrics dictated in the FDA’s draft guidance are about three times higher than the FDA’s original estimates. Read More
The FDA is calling out a Taiwanese drugmaker for a slew of GMP violations circling its quality control unit's written procedures, rendering its products adulterated. Read More