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27 June 2019 - The draft guidance, Treatment for Heart Failure: Endpoints for Drug Development, when finalised, will describe the agency’s ...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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NHS publishes update on the use of biosimilars

5 June 2019 - The United Kingdom’s National Health Service (NHS) has published a new document for clinical and nonclinical ...

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Consultation on draft guideline on quality requirements for medical devices in combination products

3 June 2019 - EMA has released a draft guideline on the quality requirements for medical devices in human medicines ...

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FDA replaces withdrawn biosimilar guidance with new one on quality-related considerations

21 May 2019 - A week after finalizing guidance on developing interchangeable biosimilars, the US FDA has drafted guidance for ...

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Framework for the regulation of regenerative medicine products

21 May 2019 - The U.S. FDA has published four final guidance documents that are part of a comprehensive policy framework ...

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Considerations in demonstrating interchangeability with a reference product guidance for industry

9 May 2019 - This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable ...

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FDA issues draft guidance to industry on submitting real-world evidence in new drug and biologic applications

8 May 2019 - Today, the U.S. FDA published the draft guidance, Submitting Documents Using Real-World Data and Real-World Evidence ...

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FDA advances the science of patient input by seeking specific feedback on patient preferences that may impact regulatory decisions on medical devices

2 May 2019 - The U.S. FDA today opened a docket to receive input from stakeholders on a new priority ...

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FDA's efforts to advance the development of gene therapy

1 May 2019 - Gene therapy has been on the horizon for several decades and has now become a reality in ...

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NICE launches online resource to help development and adoption of new health technologies

29 April 2019 - HealthTech Connect, a new online resource provided by NICE to help identify and support new health technologies ...

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FDA's efforts to advance the development of biologics

17 April 2019 - The FDA’s Center for Biologics Evaluation and Research is working at the forefront of 21st century ...

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Minimal residual disease as a surrogate outcome for product development for multiple myeloma: comparing FDA and EMA guidances

8 April 2019 - This article discusses the need to update regulatory science to include the use of minimal residual disease ...

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