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A new report by the UK’s Royal Statistical Society (RSS) proposes sweeping reforms aimed at minimizing the risk to volunteers in drug trials, maximizing design efficiency and enhancing scrutiny of clinical trial protocols.
Educating GMP laboratory analysts on good laboratory practices (GLP) goes a long way in reducing staff resistance to incorporating GLPs into GMP lab operations, according to Kristin Arpin, a quality assurance expert with Purdue Pharma.
Singapore’s Parliament Feb. 12 adopted legislation to regulate the manufacture, import, supply, labeling and advertisement of all health products and active ingredients.
Clinical sites must use care when billing Medicare for costs incurred in clinical trials, or they run the risk of being charged under the federal False Claims Act, which can result in criminal liability.
The FDA acknowledged the need for greater transparency and an increased focus on safety in its drug review process through a series of recommendations it issued.
A newly published survey suggests that orthopedists want to see a shorter FDA drug approval process and a return to the market of Vioxx, despite the agency’s concerns with the drug.
In the last year, more out-of-court settlements between generic and brand companies involved reverse payment deals than in the two previous years combined, according to a new FTC report.
The process for institutional review boards (IRBs) to refer potentially high-risk clinical trials involving children to the FDA for special review is laid out in detail in a new guidance document.
Because all FDA centers and various regulations are involved with combination products, whatever is happening with these devices will have an impact on all other products, said Mason Diamond, vice president of clinical and regulatory affairs for TyRx Pharma.