Drugs Devices

• The FDA has allowed companies to sell drugs and devices while completing safety and efficacy studies, but many of these postmarket requirements are now overdue or behind schedule. • FDA leaders announced in February that the default requirement for agency approvals will shift to one clinical trial instead of two. • This shift increases the reliance on postmarket studies to ensure patient safety, meaning more risk may fall on users if companies fail to finish their required research.

• An analysis of FDA data revealed that hundreds of required postmarket studies for drugs and medical devices are running behind schedule. • The findings indicate that many manufacturers have failed to complete follow-up research mandated by the agency years after product approval. • These delays hinder the FDA's ability to monitor long-term safety and effectiveness, potentially leaving patients at risk from undetected side effects.

• The FDA has allowed many pharmaceutical companies to delay or ignore required safety and efficacy studies for drugs and devices already on the market. • Agency records show that these "postmarket" studies, intended to verify a product's performance after approval, are frequently behind schedule or overdue. • This lack of oversight means patients may use medications, such as the autoimmune drug Tavneos, without the full safety data originally requested by agency experts.