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Manufacturers of laboratory-developed tests (LDT) are concerned that the FDA will lack the resources to deal with a flood of premarket approval applications as the agency implements its recent final rule asserting oversight of LDTs as medical devices. Read More
The Supreme Court voted 6-3 on Monday to lay out a new standard that makes it easier for companies and other entities to challenge federal rules, potentially allowing new challenges to regulations that have been in place for decades. Read More
The Supreme Court’s reversal of a 40-year-old precedent that had smoothed the regulatory agency pathway now makes it easier for courts to step in with their own interpretation of a law’s effect on regulatory issues. Read More
The FDA has published overdue draft guidance on developing diversity action plans for clinical trials, moving the agency a step closer to the statutory mandate that all phase 3 trials include such plans. Read More
Assuring the consistent performance of a drug-delivery combination product through the outputs that measure that performance is the focus of an FDA draft guidance released July 1. Read More