Cost of clinical trials for new drug FDA approval are fraction of total tab

24 September 2018 - Clinical trials that support FDA approvals of new drugs have a median cost of $19 million, ...

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Harvard Professor's attack on pharma's clinical trials is absurd

18 September 2018 - Dr. Marcia Angell, a senior lecturer at Harvard Medical School and the first woman to serve as ...

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Antimicrobial resistance: FDA discusses reimbursement reforms

17 September 2018 - Reimbursement reforms for antimicrobial treatments could include “a mix of milestone payments and subscription fees for ...

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Can a cancer drug originated in China be a success in the U.S.?

13 September 2018 - While China has prospered in a variety of technologies over the last decade, one area where growth ...

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BIO, Allergan and Roche call for FDA flexibility with patient experience data

13 September 2018 - Industry group BIO and biopharma companies Allergan and Roche are calling for the FDA to be ...

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Hospitals are fed up with drug companies, so they’re starting their own

6 September 2018 - A group of major American hospitals, battered by price spikes on old drugs and long-lasting shortages ...

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Statement from FDA Commissioner on the agency’s global efforts to help assure product quality and transparency at foreign drug manufacturing facilities

5 September 2018 - Over the past 25 years, globalisation of drug manufacturing has prompted the FDA to change its ...

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FDA pushes for development of non-opioid pain medications

29 August 2018 - The FDA is planning new steps to encourage the development of nonaddictive alternatives to opioid pain ...

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Pfizer calls for FDA guidance to address false and misleading biosimilar advertisements

28 August 2018 - Taking issue with Amgen, Genentech and other reference product sponsors’ dissemination of misleading information on biosimilars, ...

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FDA adds four tropical diseases to priority review voucher program to encourage drug development in areas of unmet need

23 August 2018 - Today, the U.S. FDA announced the addition of Lassa fever, chikungunya virus disease, rabies and cryptococcal meningitis ...

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FDA supports critical research to spur innovation for continuous manufacturing technology to support and advance drug and biologics development

1 August 2018 - We know that novel manufacturing technologies for both small-molecule drugs and biological products have great potential to ...

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Drug companies can’t game paediatric drug laws anymore

26 July 2018 - Drug companies can’t avoid including kids in certain clinical studies now that the FDA has finally ...

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FDA budget matters: investing in advanced domestic manufacturing

13 July 2018 - There’s new technology that can improve drug quality, address shortages of medicines, lower drug costs, and bring ...

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Deloitte survey finds biopharma companies are accelerating adoption of real-world evidence

28 June 2018 - A recent survey shows that 90% of biopharma companies are making significant investments in real-world evidence ...

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The biopharmaceutical industry provides 75% of the FDA's drug review budget. Is this a problem?

28 June 2018 - Caroline Chen of ProPublica has written a provocative article challenging the objectivity of the FDA in its ...

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