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FDA issues draft guidance to industry on submitting real-world evidence in new drug and biologic applications

8 May 2019 - Today, the U.S. FDA published the draft guidance, Submitting Documents Using Real-World Data and Real-World Evidence ...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

8 April 2019 - Biopharmaceutical products (also known as biologics) are among the most expensive pharmaceutical products on the market, and ...

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NICE encourages use of greener asthma inhalers

8 April 2019 - People with asthma will be helped to choose the inhaler that is best for them, and best ...

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FDA affirms its commitment to efficient adoption of Risk Evaluation and Mitigation Strategy plans and to making sure they do not impede generic drug development

4 April 2019 - Today, the U.S. FDA issued guidance for industry, REMS: FDA’s Application of Statutory Factors in Determining When ...

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FDA takes new steps to advance natural history studies for accelerating novel treatments for rare diseases

22 March 2019 - The U.S. FDA today issued the draft guidance, Rare Diseases: Natural History Studies for Drug Development.  ...

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PBAC report - Options for listing PD-(L)1 checkpoint inhibitors for multiple cancer indications on the PBS

22 March 2019 - The PBAC Report to the Minister for Health on “Options for listing PD(L)-1 checkpoint inhibitors for multiple ...

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FDA implements new policies to advance the development of drugs to treat or prevent HIV, including in paediatric patients, as part of efforts to end HIV infection

19 March 2019 - The U.S. FDA today issued two final guidances for industry to help product sponsors understand the ...

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FDA is working to bridge gaps and meet needs for rare disease product development

28 February 2019 - There are approximately 7,000 rare diseases affecting an estimated 30 million people in the United States.  ...

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FDA advances new efforts to promote development of safe and effective regenerative medicine products

15 February 2019 - Today, the FDA finalised two guidance documents regarding regenerative medicine therapies.  ...

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