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18 October 2019
Following Takeda Pharmaceuticals’ recall of its hypoparathyroidism drug Natpara (parathyroid hormone) early last month, people who need the drug to stay alive are struggling to find it and ending up in the hospital.

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18 October 2019
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced recommendations for seven new medicines for approval, including a conditional marketing authorization for Merck’s Ebola vaccine Ervebo ...
18 October 2019
The revised draft guidance from the US Food and Drug Administration (FDA) on drug master files (DMFs) deals with submissions on confidential information about facilities, manufacturing, processing, packaging and storing drugs.
18 October 2019
Two House committees on Thursday advanced on party-line votes Speaker Nancy Pelosi’s (D-CA) bill to allow for the negotiation of certain medicine prices as part of plans to bring down costs in the US.
17 October 2019
The US Department of Health and Human Services’ Office of Inspector General (OIG) will issue a report next year on the US Food and Drug Administration’s (FDA) postmarket surveillance of medical devices, which has come under fire in recent months.
17 October 2019
Drugmakers and industry groups are calling on the US Food and Drug Administration (FDA) to expand and clarify its recent draft guidance on how to use its inactive ingredient database (IID).
17 October 2019
The Belgian Competition Authority (BCA) said recently that it’s inspecting the premises of companies suspected of using restrictive practices to limit, delay or prevent the entry of biosimilar competition.