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The FDA may be making life easier for researchers conducting studies in emergency settings when patients are unable to give their informed consent, issuing a draft guidance on informed consent exceptions Aug. 29.
The FDA published its annual guidance document agenda and is seeking public comments on possible topics for future guidance development and revisions to existing documents.
The FDA has come through on its promised new rule designed to improve its drug directory by replacing the paper-based drug registration system with an electronic one.
The UK’s National Institute for Health and Clinical Excellence (NICE) does not believe that two cancer drugs, Roche Products’ Avastin and Merck Pharmaceuticals’ Erbitux, should be used in treating metastatic colorectal cancer, a recent draft report says.
The HHS Office of Inspector General’s (OIG) assessment of state qui tam programs will be a hotly debated issue for observers of a new law providing states with an increased share of Medicaid funds, industry sources say.
The FDA is pledging to clarify its final guidance for premarket approval and 510(k) premarket notification applications of biomarker tests, while rejecting industry criticism that the agency’s approach is overly burdensome, an agency official said.
To curb an ever-growing number of medical errors involved in the administration and prescription of drugs, the federal government and industry must overhaul the way medications are named, labeled and packaged, a recent federal study found.
In the wake of a clinical trial catastrophe that left six healthy volunteers in comas this past spring, a British pharmaceutical industry task force has proposed tougher guidelines governing investigations of new drugs in humans.
The FDA is rejecting industry concerns that its guidance for premarket approval and 510(k) premarket notification applications of biomarker tests may be overly burdensome, while pledging to clarify the final guidance, an agency official said.
The FDA Aug. 3 posted guidance on how device firms can qualify for small business user fee discounts and waivers for agency reviews of their products under the Medical Device User Fee and Modernization Act (MDUFMA) in fiscal 2007.