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FDA Cautions 2 HIV Test Distributors

[ Price : $8.95]

FDA cautions registrants of two Web sites promoting iCare HIV tests that the tests are not approved for sale in the U.S.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include Apotex Research Private Ltd., Paramesh Banerji Life Sciences, Signat...

Draft Guide on Drug Study Expansion Cohorts

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Federal Register notice: FDA makes available a draft guidance entitled Expansion Cohorts: Use in First-In-Human Clinical Trials to...

Workshop on Patient Perspectives Used for Clinical Trials

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Federal Register notice: FDA announces a 10/15-16 public workshop to convene a discussion on methodological approaches that may be...

Mobile App Cleared as Contraceptive Method

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FDA grants de novo marketing for Natural Cycles Nordics Natural Cycles mobile medical application that can be used as a method of ...

Hologics Cynosure Unit Suspends Marketing of Vaginal Device

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Hologics Cynosure division suspends marketing and distribution of its TempSure Vitalia handpiece and probe, which is used for heat...

Court Denies J&J Motion Against Pfizers Biosimilar

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A federal court in Pennsylvania denies a Johnson & Johnson motion to dismiss an antitrust civil action brought by Pfizer over infl...

7D Surgical Cranial Surgery Module Cleared

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FDA clears a 7D Surgical 510(k) for the Cranial Module for use on its Machine-vision Image Guided Surgery system for cranial surge...

FDA to Study Overwarning in DTC Ads

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FDA proposes a new Experimental Study of Risk Information Amount and Location in Direct-to-Consumer (DTC) Print Ads that is intend...

FDA Accepts UCB NDA for Seizure Nasal Spray

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FDA accepts for review a UCB NDA for midazolam nasal spray, an investigational product for the acute treatment of seizures in pati...