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22 March 2019 - The U.S. FDA today issued the draft guidance, Rare Diseases: Natural History Studies for Drug Development.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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Statement from FDA Commissioner on new programs to promote the adoption of innovations in drug manufacturing that can improve quality and lower drug costs

13 February 2019 - Ensuring the safety of our nation’s drug supply is a cornerstone of our consumer protection mission.  ...

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FDA updates guidance on development of rare disease therapies

17 January 2019 - The FDA has revised its draft guidance for developing rare disease treatments to include the use ...

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Statement from FDA Commissioner and Director of the Center for Biologics Evaluation and Research on new policies to advance development of safe and effective cell and gene therapies

15 January 2019 - The FDA is witnessing a surge of cell and gene therapy products entering early development, evidenced ...

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Revised guideline aims to strengthen global approach to development of new antibacterial medicines

14 January 2019 - EMA has published a PDF revision of its guideline on the evaluation of human medicines ...

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FDA advances new scientific framework to promote greater predictability, efficiency in oncology drug development

19 December 2018 - Today, the U.S. FDA issued guidance, Clinical Trial Endpoints for the Approval of Cancer Drugs and ...

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Statement from FDA Commissioner and Director of the Center for Devices and Radiological Health on new steps to promote innovations in medical devices that help advance patient safety

18 December 2018 - Spurring innovation of medical products so that patients can have access to safe, effective treatments that ...

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Statement from FDA Commissioner and Director of FDA’s Center for Drug Evaluation and Research on efforts to modernise generic drug labels while maintaining the efficiency of generic development

13 December 2018 - Protecting patient safety is at the core of the FDA’s mission. All FDA-approved drugs have benefits and ...

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Statement from FDA Commissioner on new actions advancing the agency’s biosimilars policy framework

11 December 2018 - Our public health obligations touch on many aspects of how medical products are developed and used ...

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Statement from FDA Commissioner on FDA’s new strategic framework to advance use of real-world evidence to support development of drugs and biologics

6 December 2018 - The health care system is integrating more effective ways to leverage electronic tools to gather and use ...

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Statement from FDA Commissioner on the FDA’s new effort for developing and class labelling of in vitro companion diagnostics for classes of oncology therapeutic products

6 December 2018 - One challenge we face right now, when it comes to developing diagnostics that can help target ...

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