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The FDA has withdrawn from the Global Harmonization Working Party (GHWP) and will focus its efforts to ensure alignment of medical device international harmonization by primarily working with the International Medical Device Regulators Forum (IMDRF). Read More
As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and regulations that could impact your business. Read More
The lot size doesn’t really matter when it comes to choosing a sample size for a pharmaceutical or medical device, says sampling expert Steven Walfish. Read More
Upcoming events in the coming weeks and months include three FDA advisory committee meetings; MAGI 2024: The Clinical Research Conference; and webinars on medical device cybersecurity, overcoming common clinical trial challenges, supplier quality agreements and FDA inspections. Read More
This edition of Quick Notes highlights a major supplier’s data breach, good news for wearable defibrillator and renal denervation devices, and labeling to remind surgeons about nonapproved mesh products. Read More
Reorganization of two of the FDA’s larger offices in 2024 will bring about changes in how the agency handles inspections and drug assessments. Read More
When the rare disease patient community was seeking to have the FDA pay more focused attention to orphan drugs, they asked Janet Woodcock for support. She established within CDER a new office dedicated to orphan drugs and rare diseases. Read More
As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and regulations that could impact your business. Read More