Last week, the House Energy and Commerce Committee’s Health Subcommittee held a hearing on drug safety. A quick report: Chairman Waxman’s opening comm
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REMS
FDA Releases Draft Guidance on Risk Evaluation and Mitigation Strategies
By Sean Wajert on
Posted in Articles, Drug and Device
The FDA has released its draft guidance on Risk Evaluation and Mitigation Strategies, or REMS, laying out guidelines for how pharmaceutical companies …
Continue Reading FDA Releases Draft Guidance on Risk Evaluation and Mitigation Strategies
How To Deal With Litigation-Related Concerns In “REMS” For Biologics
By Sean Wajert on
Posted in Articles, Drug and Device
Last year’s Food and Drug Administration Amendments Act gave the FDA increased authority to require Risk Evaluation and Mitigation Strategies (R…
Continue Reading How To Deal With Litigation-Related Concerns In “REMS” For Biologics