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Comments Sought on Dispute Resolution Guidance Extension

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Federal Register: FDA seeks comments on an information collection extension related to a guidance on formal dispute resolution on ...

Guide on Labeling for Ultrasonic Surgical Aspirator Devices

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FDA posts a guidance entitled: Product Labeling for Certain Ultrasonic Surgical Aspirator Devices that describes the agencys curre...

Bill Would Require HHS Drug Price Negotiations

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Four congressional Democrats introduce a bill to require HHS to negotiate prices for Medicare Part D covered drugs.

FDA Clears Nitiloops Nova Cross Extreme and BTK Catheters

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FDA clears a Nitiloop 510(k) for the Nova Cross Extreme and Nova Cross BTK, dedicated microcatheters for use in conjunction with c...

Tesaro sNDA for Varubi IV Approved

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FDA approves a Tesaro supplemental NDA for Varubi (rolapitant) IV in combination with other antiemetic agents in adults for preven...

Guide on 510(k)s for Device Changes

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Federal Register notice: FDA makes available a guidance entitled Deciding When to Submit a 510(k) for a Change to an Existing Devi...

Achaogen Files NDA for New Antibiotic

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Achaogen files an NDA for plazomicin, indicated for treating complicated urinary tract infections.

Amneal Asks Forteo Generic Restrictions

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Amneal Pharmaceuticals says FDA should not approve any ANDA citing its Forteo as the reference-listed drug that does not contain r...

Pediatric GERD Drug Development Guidance

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FDA issues a draft guidance to help sponsors develop pediatric drugs to treat GERD.

Hologic Panther Fusion Paraflu Assay Cleared by FDA

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FDA clears a Hologic 510(k) for its Panther Fusion Paraflu assay, a multiplexed assay which runs on the new Panther Fusion system.