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The FDA’s processes are threatened by a new legal approach that would deny access to approved drugs based on non-medical issues, the petition claimed. Read More
UK officials will hand over their work in the EU’s Pharmacovigilance Risk Assessment Committee, the Committee for Medicinal Products for Human Use and the Committee for Advanced Therapies. Read More
The EU reassigned oversight of more than 370 centrally authorized drugs from UK agencies to other EU member states in anticipation of Brexit. Read More
A group of hemophilia patients and activists petitioned the FDA to hold a public hearing on court-ordered drug restrictions after an intellectual property suit filed by Shire requested restricted access for the hemophilia medication Hemlibra (emicizumab-kxwh). Read More
Rep. Keith Ellison (D-Minn.) questioned the appointment of CVS Caremark vice president and former Pfizer executive Daniel Best to oversee HHS drug pricing reforms in a letter to Secretary Alex Azar. Read More
Sens. Elizabeth Warren (D-Mass.) and Patty Murray (D-Wash.) prodded the White House to say what it’s doing to implement the 56 recommendations issued in November by the President’s Commission on Combating Drug Addiction and the Opioid Crisis. Read More
The FDA adopted an addendum updating the ICH’s E11 guideline on pediatric clinical trials, outlining ethical considerations, age classifications, pediatric drug formulations, practicalities in clinical trials and approaches to optimizing drug development. Read More