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Although the American Association for Clinical Chemistry (AACC) supports a recent FDA guidance on informed consent for in vitro diagnostic (IVD) device clinical trials, the group says several guidance details remain unclear.
The FDA recently received comments on its "Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials -- Draft Guidance for Industry and FDA Staff," issued May 23.
The FDA’s Center for Biologics Evaluation and Research (CBER) has issued a guidance on how manufacturers of biologic products should submit their lot release protocols in electronic format to CBER’s Product Release Branch.
The FDA is actively seeking to encourage adaptive clinical trials by planning to issue five new guidances and setting up special teams to provide designers of adaptive clinical trials with consulting advice, a high-ranking FDA official announced.
The FDA has published new guidance on when companies should communicate product information to the public via electronic technologies, such as the internet, and how that information should be formatted.
The FDA published draft guidance June 20 to help devicemakers understand the process for the review of clinical and nonclinical information in premarket approval (PMA) applications and related inspections under the bioresearch monitoring (BIMO) program.
The FDA published draft guidance June 19 to assist devicemakers in preparing for FDA's review of their premarket approval (PMA) applications and for coordinating inspections for PMA supplements.
The FDA’s move to harmonize its approach to risk management with its European counterparts could prove too expensive for many pharmaceutical companies to handle, potentially leading some products to be withdrawn from the market, an industry consultant said.