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Reviewers Question Alkermes Depression Combo Drug

[ Price : $8.95]

FDA medical reviewers raise questions about several aspects of an Alkermes NDA for a combination drug to treat major depressive di...

Latest FDA Innovation Plan Announced

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FDA commissioner Scott Gottlieb introduces a new Plant and Animal Biotechnology Innovation Action Plan to help ensure the safety o...

FDA Allows Extended Expiry Dates for Epinephrine Injection

[ Price : $8.95]

Due to supply shortage concerns, FDA allows two-month expiry date extensions on some epinephrine auto-injectors, 0.15 mg and 0.30 ...

Comments Sought on Surrogate Endpoint Table

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Federal Register notice: FDA opens a public docket to receive suggestions and comments on the agencys publication of its surrogate...

FDA Denies Hearing on CDER Denial of Oxycodone NDA

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Federal Register notice: FDAs chief scientist denies a request for a hearing on a CDER proposal to refuse approval of a Pharmaceut...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include Boule Medical, Cardiomed Supplies, Gaeltec Devices and Leventon.

Bone Conduction Hearing System into Class 2

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Federal Register notice: FDA classifies the active implantable bone conduction hearing system into Class 2 (special controls).

Class 2 for Humidified Oxygen Delivery Devices

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Federal Register notice: FDA classifies high-flow humidified oxygen delivery devices into Class 2 (special controls).

Rebinyn Regulatory Review Period Determined

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Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Novo Nordisks Rebin...

Align Technology Gains Clearance for Revised Invisalign

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FDA clears an Align Technology 510(k) for the Invisalign treatment with mandibular advancement, a clear aligner solution for Class...