We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
India’s Parliamentary Standing Committee on Health and Family Welfare is taking the next step in its effort to regulate the more than 5,000 unapproved fixed dose combination (FDC) products on the market in the country, calling for recommendations from technical experts. 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PhRMA is pushing back against the centerpiece of the FDA’s draft guidance on antibacterial drug development, saying superiority trials for antibacterials that treat drug-resistant infections are “neither routinely possible nor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
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
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
While FDA’s CDER breakthrough therapy designations for new drug products have taken off dramatically, CBER has been a lot more conservative in approving applications for the new designation. Read More
The FDA does not intend to prevent compounders from making preterm birth drug Makena (hydroxyprogesterone caproate), the agency stated in a legal filing earlier this month that outlines how it intends to approach one contentious issue involving compounders. Read More
The FDA’s new breakthrough therapy designation has exploded in popularity, the agency says. As of Nov. 22, 108 requests for breakthrough designation have been submitted. Read More