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The Centers for Medicare & Medicaid Services (CMS) is encouraging states to band together to negotiate deeper discounts from pharmaceutical firms on prescription drugs purchased under the Medicaid program.
The FDA has released two draft guidances prepared under the auspices of the International Conference on Harmonisation (ICH) for assessing possible cardiac risks associated with new drugs.
The FDA will impose a partial or complete clinical hold on research studies involving human drugs and biologics in cases where a clinical investigator has committed serious violations of FDA regulations or submitted false data to the agency or trial sponsor.
The FDA is on the verge of releasing a new guidance document that addresses the use of computerized systems in clinical trials, a move that could help the agency establish a consistent, risk-based approach to Part 11 for all segments of the pharmaceutical industry.
GlaxoSmithKline (GSK) has begun posting online the results of clinical trials the company sponsors, releasing summaries of more than 60 studies about its Type 2 diabetes drug Avandia.
The FDA is poised to release a new guidance document that addresses the use of computerized systems in clinical trials, a move that could help the agency establish a consistent, risk-based approach to Part 11 for all segments of the pharmaceutical industry.
The FDA should apply the same risk/benefit decisions that have accelerated the approval of new cancer treatments to therapies for other serious degenerative disease states, according to Johnson & Johnson (J&J).
As part of its continuing effort to accelerate drug development, the FDA’s Pharmaceutical Science Advisory Committee will meet Oct. 19 to evaluate research opportunities under the agency’s Critical Path Initiative.
Some drug manufacturers may decide the risks outweigh the rewards of disease awareness communications, if the FDA finalizes a draft proposal that says help-seeking messages must be perceptually distinct from specific drug ads or face agency rules governing advertising, Pfizer said.
The FDA will halt either partially or completely clinical studies involving human drugs and biologics in cases where a clinical investigator has committed serious violations of FDA regulations or submitted false data to the agency or trial sponsor, according to the agency.