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Allergenic Products Advisory Panel Meeting Canceled

[ Price : $8.95]

Federal Register notice: FDA cancels an 11/7 Allergenic Products Advisory Committee meeting that was scheduled to discuss the use ...

Modified Publication for Device Consensus Standards

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Federal Register notice: FDA makes available a publication containing modifications to the list of standards it recognizes for use...

Approval Withdrawn for 20 NDAs

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Federal Register notice: FDA withdraws the approval of 20 NDAs from multiple applicants after they notified the agency that the dr...

Regulatory Review Period Determined for Imfinzi

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Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for MedImmunes Imfinzi ...

Former FDA Associate Chief Counsel Joins Ropes & Gray

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Former FDA Associate Chief Counsel for Enforcement Beth Weinman joins Ropes & Gray at its Washington, D.C. office as counsel in th...

510(k) Pilot for Optical Coherence Tomography Devices

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FDA announces a voluntary Optical Coherence Tomography Premarket Notification (510(k)) Pilot Program, which is intended to develop...

New Use Cleared for Levita Magnetic Surgical Device

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FDA clears a Levita Magnetics 510(k) for an expanded indication to market the companys Levita Magnetic Surgical System for use in ...

Regenerons Dupixent Approved for Asthma

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FDA approves Regenerons Dupixent dupilumab) as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 ye...

Latest Federal Register Notices

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FDA Review posts the Federal Register notices for the week ending 10/19/2018.

Quantitative Efficacy/Risk Info in DTC Ads

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Federal Register notice: FDA makes available a draft guidance entitled Presenting Quantitative Efficacy and Risk Information in Di...