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…
The House will take up nearly five dozen bills on the opioids crisis and the Senate will hear from HHS Secretary Alex Azar on drug prices in what will be…
HHS released its latest regulatory agenda for in-development rulemakings including 20 specific to the FDA. Source: Drug Industry Daily
The FDA’s draft guidance on inclusion of pregnant women in clinical trials needs some fine tuning, according to stakeholders, including more clarity on non-adherence to therapies. Source: Drug Industry Daily
The Federal Trade Commission filed an amicus brief in the case of Takeda v. Zydus, urging the U.S. District Court of New Jersey to reject the notion that patent infringement…
The FDA warned API and finished drug manufacturer IDT Australia for failure to investigate quality issues and for incomplete records. Source: Drug Industry Daily