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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Subscription model for antibiotic development

6 September 2019 - An unlikely answer to the global crisis in antibiotic resistance. ...

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Who’s missing from breast cancer trials? Men, says the FDA

9 September 2019 - Men do get breast cancer, but they account for fewer than 1 percent of patients and often ...

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Promoting paediatric drug research and labelling — outcomes of legislation

28 August 2019 - Congress has modified regulations of the FDA to promote research assessing the efficacy and safety of drugs ...

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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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Congress should be promoting, not discouraging, the development of biosimilars

27 August 2019 - Drug prices continue to dominate the headlines, yet many of the policy ideas being considered in ...

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Developing real-world data and evidence to support regulatory decision-making

26 August 2019 - On 3 October, the FDA and the Duke-Margolis Center for Health Policy will hold a conference, ...

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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26 August 2019 - The draft guidance, Male Breast Cancer: Developing Drugs for Treatment, includes draft recommendations for inclusion of males ...

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Syapse announces research collaboration with the FDA focused on the regulatory use of real-world evidence

14 August 2019 - Collaboration will advance the derivation of real-world oncology endpoints and provide insights into the use of real-world ...

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FDA issues draft guidance regarding clinical trial design for newborns

31 July 2019 - Today, the U.S. Food and Drug Administration issued the draft guidance, General Clinical Pharmacology Considerations for Neonatal ...

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Vas Narasimhan of Novartis: ‘we are not at all prepared for a pandemic’

1 August 2019 - The son of Indian immigrants read Greek philosophy and worked at McKinsey before joining a giant drug ...

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Supporting medicine developers in generating quality data packages in early access approaches (PRIME and breakthrough therapies)

31 July 2019 - EMA and the US FDA have published today a report on their joint workshop with stakeholders ...

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Harms from uninformative clinical trials

25 July 2019 - Individuals who enroll in clinical trials do so with the belief that their participation will help ...

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Trump to order drive for improved flu vaccine

16 July 2019 - President Donald Trump is readying an executive order that would direct HHS to overhaul the development ...

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New drugs: where did we go wrong and what can we do better?

10 July 2019 - More than half of new drugs entering the German health care system have not been shown to ...

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