The FDA launched The Adverse Event Monitoring System (AEMS), calling it a major achievement in the agency’s mission to modernize and provide radical transparency into the safety of regulated products.
The draft guidance covers DCT design, informed consent, the use of remote clinical trial visits, safety monitoring and software used in conducting DCTs for drugs, biological products, and devices. The comment period is open until August 1, 2023.
The FDA has granted several exemptions to its Medical Device Reporting requirements related to events identified in certain real-world data sources, such as medical device registries.
The center is proposing that Philips repair, replace or refund recalled devices manufactured after November 2015.
The Class I recall affects more than 95,000 devices in the United States.
FDA also supports the removal of the HeartWare HVAD System from the market.
The medical device reports describe both patient infections and other possible contamination issues.
Bayer’s second quarterly analysis report of adverse event information includes nearly 12,000 serious injuries, 45 malfunction reports and nine deaths.
The pandemic is helping realize the potential of ISO IDMP data standards in relation to adverse event reporting, electronic prescribing and medicines control in the supply chain.
A product issue could lead to serious health consequences, including loss of consciousness, bleeding, fluid buildup around the heart and death.