Blog
RSS FeedPosted by Michael Wonder on 12 Dec 2019
FDA issues draft guidance to foster oncology product development for paediatric populations
12 December 2019 - Today, the U.S. FDA issued a draft guidance document, “FDARA Implementation Guidance for Pediatric Studies of ...
Posted by Michael Wonder on 01 Dec 2019
Adaptive design clinical trials for drugs and biologics guidance for industry
29 November 2019 - This document provides guidance to sponsors and applicants submitting investigational new drug applications, new drug applications, biologics ...
Posted by Michael Wonder on 13 Nov 2019
ICER finalises method adaptations for assessing potential cures and other high-impact single or short-term therapies
12 November 2019 - Collaborative project with NICE and CADTH leads to important adaptations for ICER’s methods including creation of optimistic ...
Posted by Michael Wonder on 22 Oct 2019
Roche app allows access to latest cancer guidelines
21 October 2019 - Roche has launched an app allowing access to the latest guidelines covering the most common forms ...
Posted by Michael Wonder on 10 Oct 2019
FDA cuts red tape in diagnosis applications for cancer trials
10 October 2019 - Drug companies developing cancer treatments can fold the risk assessment of unapproved screening tests into their ...
Posted by Michael Wonder on 30 Sep 2019
FDA issues draft guidance on patient-focused drug development: methods to identify what is important to patients
30 September 2019 - Today the U.S. FDA issued a draft guidance on Patient-Focused Drug Development: Methods to Identify What Is ...
Posted by Michael Wonder on 22 Sep 2019
Interacting with the FDA on complex innovative trial designs for drugs and biological products
20 September 2019 - This document provides guidance to sponsors and applicants on interacting with the FDA on complex innovative trial ...
Posted by Michael Wonder on 16 Sep 2019
FDA seeks input on product-specific guidances to facilitate generic drug development
16 September 2019 - Today, FDA published 53 product-specific guidances (PSGs) – 34 new guidances and 19 revised guidances, including ...
Posted by Michael Wonder on 04 Sep 2019
Health Canada updates its biosimilar fact sheet
4 September 2019 - Health Canada recently updated its fact sheet on biosimilars, including new or clarified information about key ...
Posted by Michael Wonder on 29 Aug 2019
EMA offers edits on FDA draft guidance on biosimilars
29 August 2019 - Although regulators rarely offer public comments on another regulator’s guidance, the European Medicines Agency (EMA) late ...
Posted by Michael Wonder on 28 Aug 2019
FDA urges inclusion of men in breast cancer clinical trials
28 August 2019 - Men with breast cancer make up less than one percent of all breast cancer cases, but ...
Posted by Michael Wonder on 28 Aug 2019
Placebos and blinding in randomised controlled cancer clinical trials for drug and biological products: guidance for industry
28 August 2019 - This guidance provides recommendations to industry about the use of placebos and blinding in randomised controlled clinical ...
Posted by Michael Wonder on 26 Aug 2019
FDA encourages inclusion of male patients in breast cancer clinical trials
26 August 2019 - The draft guidance, Male Breast Cancer: Developing Drugs for Treatment, includes draft recommendations for inclusion of males ...
Posted by Michael Wonder on 22 Aug 2019
Updated procedure and submission guidelines for the CADTH Common Drug Review
22 August 2019 - The Procedure and Submission Guidelines for the CADTH Common Drug Review has been updated with the ...
Posted by Michael Wonder on 08 Aug 2019
NICE draft guidance and NHS England review highlight need for more research on cannabis-based medicinal products
8 August 2019 - The fast-tracked guidance follows the re-classification of these products last year to allow specialist doctors to ...