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The FDA has issued a new International Conference on Harmonisation guidance containing recommendations for evaluating the stability data needed to propose a retest period for a drug substance and a shelf life for a drug product.
The FDA has issued a final guidance on how drugmakers and others should handle reserve testing samples used in bioavailabilty (BA) and bioequivalence (BE) studies that support new and generic drug applications, while citing past lapses in the rules governing drug testing samples.
Citing past lapses in the rules governing drug testing samples, the FDA has issued a final guidance on how drugmakers and others should handle reserve testing samples used in bioavailabilty (BA) and bioequivalence (BE) studies that support new and generic drug applications.
The FDA should go ahead with its plan to apply the same regulatory standards to direct-to-consumer (DTC) broadcast ads for restricted medical devices that apply to the same type of ads for prescription drugs, according to the FTC.
The FDA has released a new guidance updating industry on the effect various review actions have on Medical Device User Fee Modernization Act (MDUFMA) time goals during the premarket 510(k) submission process.
The HHS Office of Public Health and Science has recommended in a new final guidance document that institutions involved in FDA-regulated clinical research establish conflict of interest committees (COICs) to verify whether the institution or individual investigators have a financial stake in the outcome of the research.
The FDA has reclassified two types of dental implants from Class III to Class II to lessen the regulatory burden on devicemakers, according to a final rule and draft guidance published May 11.
A newly released final guidance on premarket assessment of pediatric medical devices clarifies the clinical definition of pediatric population to ensure young patients in clinical device trials give informed consent that does not conflict with state and federal laws.