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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but a single Phase III trial can suffice if the results are supported by additional evidence, the FDA said in a new draft guidance.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and whatever sampling methods they use are a fair representation of that target population, the FDA said in a new draft guidance.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
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 Drugs to the Office of Executive Programs, CDER Director Janet Woodcock said in a staff memo. Read More
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 a busy week for drug legislation and policy on Capitol Hill. Read More