USA – FDA issues draft guidance on developing migraine prevention drugs
The US Food and Drug Administration (FDA) on Thursday released a draft guidance to help sponsors develop drugs to prevent migraines that offers recommendations...
USA – QMSR: Start now to be ready for final rule, slated for December
The US Food and Drug Administration (FDA) asserts that it is on track to release a final rule this December that harmonizes the agency’s decades-old Quality...
International – ICH Q14: Pharma groups want clarity on benefits of enhanced approach
Pharmaceutical industry groups questioned whether following the enhanced approach in International Council for Harmonization (ICH) Q14 guidance will confer regulatory relief for manufacturers that...
USA – Industry pushes FDA for tailored complex generics post-approval changes guidance
The US Food and Drug Administration (FDA) needs to develop guidance on post-approval changes for complex generics, and to update its guidance on post-approval...
USA – FDA addresses alternative inspection tools, expectations for nitrosamine assessments in updated CPGs
The US Food and Drug Administration’s (FDA) has updated two compliance program guides (CPGs) covering pre-approval inspections (PAIs) and routine good manufacturing practice (GMP)...
USA – Califf: FDA committed to boosting complex generic drug development
Robert Califf, commissioner of the US Food and Drug Administration (FDA), said the agency is looking at new ways to assess bioequivalence and increase...
Europe – EMA accepts application for leukaemia drug from Otsuka and Astex
The application is supported by positive results from the phase 3 ASCERTAIN clinical trial which demonstrated an exposure equivalence of an oral fixed-dose of...
USA – FDA’s top 10 tips to transition your COVID-19 products
During the COVID-19 pandemic, the US Food and Drug Administration (FDA) allowed more than 4,000 medical devices and diagnostics on the market under emergency...
USA – FDA outlines criteria for conducting long-term neurodevelopmental safety studies in neonates
The US Food and Drug Administration (FDA) on Friday issued a draft guidance to assist sponsors in determining the need to conduct long-term neurodevelopmental...
USA – FDA warns pharmacy benefit company for distributing unapproved foreign drugs
The US Food and Drug Administration (FDA) recently warned pharmacy benefit firm ElectRx for substituting prescription drugs ordered by its customers with drugs sourced...
