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.
The most recent Congressional budget deal holds drug corporations responsible for 70 percent of prescription drug costs in the donut hole beginning next year, a 20 percent increase. Read More
In a second successful legal challenge of the FDA’s approach to orphan drug designations, a federal court ordered the agency to grant Eagle Pharmaceuticals orphan drug exclusivity for its cancer drug Bendeka. Read More
Clinical trials for HIV prevention drugs should generally involve two well-controlled trials, but a single Phase III trial can suffice if the results are supported by additional evidence, the FDA said in a new draft guidance. Read More
The FDA released a list of alternative suggestions for complying with CGMP requirements for drug combination products that covers stability testing, release for distribution, reserve samples and special testing requirements. Read More
Mandated under the 21st Century Cures Act, the guidance is meant to facilitate the advancement and use of systematic approaches to collect meaningful patient and caregiver data that can better inform medical product development. Read More
The complaint accuses the defendants of distributing and sponsoring unbranded promotional materials that misrepresented the risks of addiction, overdose and death associated with their products. Read More
Massachusetts opened a new front in litigation against opioid manufacturers as Attorney General Maura Healey filed a lawsuit Tuesday accusing Purdue and 16 current and former executives and directors of contributing to the opioid crisis and to the deaths of nearly 700 Massachusetts residents since 2009. Read More
Sites and sponsors should have a lot of leeway in determining how to measure patient experiences during drug development but researchers should take care that they’re focusing on the right target population and whatever sampling methods they use are a fair representation of that target population, the FDA said in a new draft guidance. Read More
Two final FDA guidances published Tuesday clarify which information drugmakers can provide to payors and what non-label information they can communicate. Read More
HHS Secretary Alex Azar elaborated on the Trump administration’s blueprint to lower drug prices at a Senate HELP Committee hearing Tuesday and said it is considering — among other actions — targeting rebates, pharmacy benefit managers and Medicare negotiations. Read More
The Office of New Drugs and the Office of Generic Drugs will continue to manage will appeals that reside at their respective office or super-office levels. Read More