20 September 2019 - This document provides guidance to sponsors and applicants on interacting with the FDA on complex innovative trial ...
16 September 2019 - Today, FDA published 53 product-specific guidances (PSGs) – 34 new guidances and 19 revised guidances, including ...
4 September 2019 - Health Canada recently updated its fact sheet on biosimilars, including new or clarified information about key ...
29 August 2019 - Although regulators rarely offer public comments on another regulator’s guidance, the European Medicines Agency (EMA) late ...
28 August 2019 - Men with breast cancer make up less than one percent of all breast cancer cases, but ...
28 August 2019 - This guidance provides recommendations to industry about the use of placebos and blinding in randomised controlled clinical ...
26 August 2019 - The draft guidance, Male Breast Cancer: Developing Drugs for Treatment, includes draft recommendations for inclusion of males ...
22 August 2019 - The Procedure and Submission Guidelines for the CADTH Common Drug Review has been updated with the ...
8 August 2019 - The fast-tracked guidance follows the re-classification of these products last year to allow specialist doctors to ...
31 July 2019 - Today, the U.S. Food and Drug Administration issued the draft guidance, General Clinical Pharmacology Considerations for Neonatal ...
29 July 2019 - The U.S. FDA today issued a revised draft guidance, Rare Paediatric Disease Priority Review Vouchers – ...
22 July 2019 - Today, the U.S. FDA released a final guidance, “Post-marketing Safety Reporting for Combination Products,” for applicants ...
27 June 2019 - Today the U.S. FDA issued a proposed rule to amend its regulations on the use of master ...
27 June 2019 - The draft guidance, Treatment for Heart Failure: Endpoints for Drug Development, when finalised, will describe the agency’s ...
25 June 2019 - NICE is looking to extend the use of real world data that will help inform its ...