Simplifying Global Compliance
Articles Tagged with ''Regulations''
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. Read More
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. Read More
Singapore’s Parliament Feb. 12 adopted legislation to regulate the manufacture, import, supply, labeling and advertisement of all health products and active ingredients. Read More
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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
The European Union (EU) Dec. 12 adopted a final regulation on the licensing and use of pharmaceuticals in children. Read More
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. Read More
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