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With the FDA set to tackle a host of new responsibilities, Congress should boost the agency’s fiscal 2014 funding to help it carry out its expanded mission, advocates for the FDA say. Read More
Covis Pharmaceuticals has received an FDA untitled letter for making unsubstantiated superiority claims and omitting vital risk information about its heart drug Lanoxin in a physician letter. 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PhRMA is pushing back against the centerpiece of the FDA’s draft guidance on antibacterial drug development, saying superiority trials for antibacterials that treat drug-resistant infections are “neither routinely possible nor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
The FDA and EMA will expand their joint inspection activities to include facilities involved with bioequivalence studies for generic drug applications. Read More
As more critics of the FDA’s approval of the painkiller Zohydro ER come forward, the agency says it will not limit approval of new opioid painkillers to those with abuse-deterrent properties. Read More
The FDA plans to mandate that manufacturers of antibacterial soaps and body washes submit clinical outcome study data that address safety and efficacy of their products, regulating them as they would other OTC medications. 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
The FDA has extended by 60 days the comment period for its proposed safety labeling rule for generic drugs. Stakeholders now have until March 13 to comment on the proposal, which would allow generic drugmakers to update labels in response to safety issues without agency approval. Read More