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Drugmakers could be required to submit less data for antibiotics and antifungals that affect limited patient populations if a new House bill aimed at building on the success of the Generating Antibiotics Now Act is passed into law. Read More
Lawmakers were closer to eliminating the 28 national clinical trial directives and establishing a single authorization procedure for all EU trials, following approval of draft language in December. Parliament is expected to take up the proposed clinical trial regulation during its March plenary session. Read More
Novartis’ valsartan woes escalated Thursday as Japan followed the U.S. in filing a legal complaint against the Swiss drugmaker over its marketing practices for the blood pressure drug. Read More
Regulatory affairs folks had little time to relax in 2013, with heated debates over the future of EU device regulations, new controls in Japan and a proposed regulatory framework in India. And that’s just the tip of things. During the year, Malaysia got busy implementing its new device law and Brazil eased the process for device registration. Members of the International Medical Device Regulators Forum cemented plans for a January launch of a single-audit pilot program, and the U.S. Food and Drug Administration finalized rules for unique device identification. Use this review to reflect on developments in 2013 and prepare a winning business strategy in 2014.Read More
The Clinical Data Interchange Standard Consortium (CDISC) is asking for input on a new data submission standard that could give clinical trial sponsors and reviewers greater flexibility if adopted by the FDA for drug review applications. Read More
The FDA has lifted a partial clinical hold on Cell Therapeutics’ blood cancer drug tosedostat, giving the green light for continuing mid-stage clinical trials. Read More
An overhaul of clinical trial regulations in the EU took a big step forward Dec. 20 as officials paved the way for revised rules to replace the current clinical trial directive in early 2014. Read More
An overhaul of clinical trial regulations in the EU took a big step forward Friday as officials paved the way for revised rules to replace the current clinical trial directive in early 2014. Read More
PhRMA is pushing back against the centerpiece of the FDA’s draft guidance on antibacterial drug development, saying superiority trials for antibacterials that treat drug-resistant infections are “neither routinely possible nor consistently ethical.” Read More
Gilead Sciences’ drug Sovaldi appears primed to dominate the hepatitis C market with the release of new Phase III trial data showing subjects with genotype 1 of the virus benefit from the drug, without coupling it with interferon. Read More