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…
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…
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.…
The FDA warned finished drugmaker Taiwan Biotech for significant CGMP violations at its facility in Taoyuan City, Taiwan, including inadequate environmental monitoring. Source: Drug Industry Daily
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…
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…
Two final FDA guidances published Tuesday clarify which information drugmakers can provide to payors and what non-label information they can communicate. Source: Drug Industry Daily
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…
An increased number of generic appeals has led CDER to transfer the management of its Formal Dispute Resolution program for sponsors of user fee products from the Office of New…
ANDA applications remain sluggish while generic drug approvals creep upward after a drop at the start of the year, the FDA said, reporting 67 generic approvals and 57 ANDA applications…