Beyond “Intent‐to‐treat” and “Per protocol”: improving assessment of treatment effects in clinical trials through the specification of an estimand

27 December 2019 - There is a key problem in randomised clinical trials as outcomes can be distorted due to ...

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FDA issues draft guidance to foster oncology product development for paediatric populations

12 December 2019 - Today, the U.S. FDA issued a draft guidance document, “FDARA Implementation Guidance for Pediatric Studies of ...

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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 ...

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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 ...

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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 ...

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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 ...

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FDA issues draft guidance on patient-focused drug development: methods to identify what is important to patients

30 September 2019 - Today the U.S. FDA issued a draft guidance on Patient-Focused Drug Development: Methods to Identify What Is ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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