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BrainStorm Gets FDA Buy-In on Special Protocol

[ Price : $8.95]

FDA issues a written agreement with BrainStorm Cell Therapeutics under a Special Protocol Assessment on the design of the companys...

Antaria API Deviations Cited

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FDA warns Australias Antaria Pty. Ltd. about CGMP deviations in its production of active pharmaceutical ingredients.

Vanda Case Could Produce Legislation: Report

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A Congressional Research Service paper points to possible legislation Congress may want to consider to clarify how FDA is to use c...

10 FDA Advisors Had Financial Ties with Abbott: KFF

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A KFF Health News report carried online by NBC says 10 members of an FDA advisory committee evaluating an Abbott cardiac device ha...

Methodological Rigor Info May Help Promotions: OPDP

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CDER Office of Prescription Drug Promotion researchers say disclosing methodological rigor in communications to healthcare provide...

Alkem Labs Hit With 10-item Form-483

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An FDA inspection last month at Alkem Laboratories India manufacturing facility leads to a 10-observation Form FDA-483.

Philips Respironics Consent Decree Approved

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A federal court approves an FDA-brokered consent decree against Philips Respironics over its defective breathing devices.

ViiV Wins Adolescent HIV Use for Dovato

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FDA approves ViiV Healthcares Dovato (dolutegravir/lamivudine) for treating HIV-1 infection in adolescents with no antiretroviral ...

Stealth Bio NDA for Barth Syndrome Accepted

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FDA accepts for review a Stealth BioTherapeutics NDA for elamipretide for treating Barth syndrome.

Spirair Nasal Septal Deviation Device Cleared

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FDA clears a Spirair 510(k) for its SeptAlign system for treating nasal septal deviation.