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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Statement by FDA Commissioner on new strategies to modernise clinical trials to advance precision medicine, patient protections and more efficient product development

14 March 2019 - Modernizing clinical trials is an agency wide priority.  ...

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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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Moving upstream in anti-cancer drug development

4 March 2019 - The development of oncology drugs traditionally begins by studying them in heavily pretreated patients, and then working ...

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Drug companies and doctors battle over the future of faecal transplants

3 March 2019 - As pharmaceutical companies seek to profit from the curative wonders of human faeces, doctors worry about new ...

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Health Canada and CADTH launch new initiative to provide early parallel scientific advice

1 March 2019 - CADTH is pleased to announce a new collaboration with Health Canada and the Institut national d'excellence en ...

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Treatment effects in multi-centre randomised clinical trials

1 March 2019 - It is common for treatments to be evaluated in clinical trials that involve many sites or centres, ...

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“Repurposing” off-patent drugs offers big hopes of new treatments

28 February 2019 - Towards the end of 2014 a 66-year-old British man named Alistair had a seizure. A scan ...

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Under representation of elderly in clinical trials: an analysis of the initial approval documents in the FDA database

25 February 2019 - A cross‐sectional, structured review of publicly available initial approval documents of FDA approved drugs was performed.  ...

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Timely, consistent, transparent assessment of market access evidence: implementing tools based on the HTA Core Model in a pharmaceutical company

21 February 2019 - Evidence requirements and assessment methods access differ between health technology assessment agencies.  ...

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NICE Scientific Advice launches collaborative programme with life sciences industry body

29 January 2019 - NICE has announced a collaboration with the body which represents life sciences organisations in the UK. ...

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Toward an effective innovation agenda

23 January 2019 - Digital technologies have transformed the U.S. and global economies, offering tremendous benefits to consumers and financial success ...

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Modernising clinical trials for patients with cancer

23 January 2019 - Clinical trials involve evaluating and validating new therapies in humans and represent the fundamental means of making ...

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Random-effects meta-analysis: summarising evidence with caveats

22 January 2019 - Questions involving medical therapies are often studied more than once. For example, numerous clinical trials have been ...

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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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