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8 June 2018Generics

BIO 2018: Gottlieb defends naming drug makers, outlines office efforts

Sometimes the pharmaceutical industry is putting in place barriers to generic makers’ ability to get access to and samples of drugs, according to Scott Gottlieb, commissioner of the US Food and Drug Administration (FDA).

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More on this story

Americas
Drug makers’ REMS misuse costs $13.4bn per year: report
6 September 2018   The misuse of federal drug programmes by branded pharmaceutical companies is costing the US healthcare system $13.4 billion per year in lost savings, a report commissioned by a generics trade group has claimed.
Americas
FDA’s Gottlieb launches biosimilars action plan
19 July 2018   The US Food and Drug Administration is not going to play regulatory ‘whack-a-mole’ with companies trying to delay or derail the entry of biosimilar competitors, according to Scott Gottlieb, commissioner of the FDA.
Americas
USFDA to modernise generic review with $37.6m funding
19 June 2018   The US Food and Drug Administration is planning to use new budget funding to modernise generic drug review and promote more widespread use of generics.

More on this story

Americas
Drug makers’ REMS misuse costs $13.4bn per year: report
6 September 2018   The misuse of federal drug programmes by branded pharmaceutical companies is costing the US healthcare system $13.4 billion per year in lost savings, a report commissioned by a generics trade group has claimed.
Americas
FDA’s Gottlieb launches biosimilars action plan
19 July 2018   The US Food and Drug Administration is not going to play regulatory ‘whack-a-mole’ with companies trying to delay or derail the entry of biosimilar competitors, according to Scott Gottlieb, commissioner of the FDA.
Americas
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