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EMA offers edits on FDA draft guidance on biosimilars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26 August 2019 - The draft guidance, Male Breast Cancer: Developing Drugs for Treatment, includes draft recommendations for inclusion of males ...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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NICE draft guidance and NHS England review highlight need for more research on cannabis-based medicinal products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 ...

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FDA issues draft guidance regarding clinical trial design for newborns

31 July 2019 - Today, the U.S. Food and Drug Administration issued the draft guidance, General Clinical Pharmacology Considerations for Neonatal ...

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FDA updates draft guidance on rare paediatric disease priority review voucher program

29 July 2019 - The U.S. FDA today issued a revised draft guidance, Rare Paediatric Disease Priority Review Vouchers – ...

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FDA reinforces need for applicants to submit thorough and timely safety information for combination medical products

22 July 2019 - Today, the U.S. FDA released a final guidance, “Post-marketing Safety Reporting for Combination Products,” for applicants ...

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Updated financial estimates workbook

5 July - An updated version of the Utilisation and cost model workbook is now available to support PBAC Submission. ...

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FDA takes new step to help advance the transition of certain biological products

27 June 2019 - Today the U.S. FDA issued a proposed rule to amend its regulations on the use of master ...

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FDA takes steps to spark development of heart failure drugs

27 June 2019 - The draft guidance, Treatment for Heart Failure: Endpoints for Drug Development, when finalised, will describe the agency’s ...

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NICE explores extending its use of real world data to inform its guidance

25 June 2019 - NICE is looking to extend the use of real world data that will help inform its ...

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