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Senator Bill Cassidy (R-LA), ranking member of the Senate Health, Education, Labor and Pensions (HELP) Committee, called out the FDA in a letter pressing federal agencies on how they will comply with the US Supreme Court’s new decision on who ultimately is in charge of interpreting federal regulations — federal agencies or the courts and Congress. Read More
This week, the FDA published a draft guidance on drug delivery outputs for devices used to deliver drugs and general principles on plan, design, and analysis of pharmacoepidemiological studies. Read More
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