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The FDA has announced a new standard format that sponsors can use to submit data to the agency regarding human drug clinical trials — a format the agency hopes will lead to greater efficiencies in clinical research and FDA reviews of new drug applications.
Two Democratic senators are mulling over the idea of forcing greater compliance with posting requirements on clinical trial drug registries by authorizing the FDA to withhold approval of clinical trial protocols pending a sponsor's commitment to list on the registry.
While the FDA’s promulgation of three draft guidance documents on risk assessment and minimization will go a long way to establishing a framework for industry and the agency, some components of the guidances may actually delay the availability of new and beneficial drugs, according to PhRMA.
GlaxoSmithKline (GSK) reversed course and said it would participate in a major clinical trial involving HIV treatment in African and other developing countries, only hours after being chastised by Rep. Henry Waxman (D-Calif.) for dropping out.
Hours after being chastised by Rep. Henry Waxman (D-Calif.) for dropping out of a major clinical trial involving HIV treatment in African and other developing countries, GlaxoSmithKline (GSK) reversed course and said it would participate in the study.
The Kentucky Supreme Court has ruled pharmaceutical companies that warn physicians about a drug’s possible side effects are generally not obligated to warn patients, regardless of whether the physicians warn their patients.
The pharmaceutical industry is not complying with a statute that mandates data on industry-sponsored cancer clinical trials be reported to a federal website, according to a powerful House lawmaker.
The HHS Office of Public Health and Science has recommended in a new final guidance document that institutions involved in FDA-regulated clinical research establish conflict of interest committees (COICs) to verify whether the institution or individual investigators have a financial stake in the outcome of the research.
Drug manufacturers have told the FDA that the number of samples recommended by the agency for testing in-process dosage units during tablet manufacturing is too high and would likely place a burden on firms.