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Mixed Reaction to Mexico Biological Drug Trade Deal

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Representatives of innovator and generic drug companies disagree on the value of a 10-year drug exclusivity provision in the trade...

End Unethical, Reckless NIH Sepsis Trial: Public Citizen

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Public Citizens call for an end to the NIH-funded CLOVERS trial it says has serious regulatory and ethical lapses.

Appeals Court Backs Eyedrop Suit Dismissal

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The 1st Circuit Appeals Court backs a federal district court decision that a suit seeking to use state laws to force prescription ...

Reflection Biotechnologies Orphan Drug Designation

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FDA grants Reflection Biotechnologies an orphan drug designation for RBIO-101, an adeno-associated virus gene therapy product for ...

Latest FDA Warning Letter

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FDA releases its latest batch of Warning Letters that includes one medical product company Kelley-Ross Compounding.

FDA Adds 4 Tropical Disease Designations

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Federal Register notice: FDA determines that chikungunya virus disease, Lassa fever, rabies, and cryptococcal meningitis satisfy i...

Pneumocystis Pneumonia Not a Tropical Disease: FDA

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Federal Register notice: FDA determines that Pneumocystis pneumonia does not meet statutory criteria for designation as a tropical...

FDA Proposes Banning 3 Bulk Drugs from Compounding

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FDA proposes to ban three bulk drug substances bumetanide, nicardipine hydrochloride, and vasopressin from its list of bulk drug...

Problems Seen in Draft Pressor Effect Guidance

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Stakeholders ask for clarifications to an FDA draft guidance on assessing drugs pressor effects.

Data-Driven Psychiatry Possible: Study

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Former FDA commissioner Robert Califf and Verily Life Sciences researchers suggest it is possible to use digital measurement tools...