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Human Drugs

Humira Patent Thicket Case Dismissal Affirmed

The 7th Circuit Court of Appeals affirms a lower court decision dismissing a suit charging that AbbVies filing of 132 additional Humira patents violat...

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Federal Register

FDA Seeks Comments on Scheduling Changes for 10 Drugs

Federal Register notice: FDA seeks comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling change...

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FDA General

Woodcock Outlines IT Transformation at FDA

Speaking at an Alliance for a Stronger FDA Webcast, FDA principal deputy commissioner Janet Woodcock says FDA is working toward new efficiencies throu...

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Federal Register

FDA Releases More ANDA Draft Bioequivalence Guides

Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that address bioequivalence study design re...

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Medical Devices

Charles River Wants Endotoxin Assay Regulation

Charles River Laboratories petitions FDA to exercise regulatory oversight over both natural and synthetic endotoxin contamination assays.

Medical Devices

Data Don't Support Breakthrough for 510(k)s: Attorney

Attorney and data scientist Bradley Thompson says FDA data support the value of a breakthrough device designation for de novo submissions but not for ...

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Medical Devices

FDA Working to Cut Ethylene Oxide Emissions

CDRH director Jeffrey Shuren describes Center efforts to help sterilization facilities to reduce ethylene oxide emissions into the environment.

Medical Devices

Juvderm Volux XC Approved for Jawline Shaping

FDA approves Allergan Aesthetics Juvderm Volux XC for improving jawline definition in adults over the age of 21 with moderate to severe loss of jawlin...

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Federal Register

E-submission Guide for Expedited Safety Reports

Federal Register notice: FDA makes available a draft guidance entitled Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies...

Human Drugs

FDA Approves Cimerli as Generic Lucentis

FDA approves Coherus Cimerli as an interchangeable generic version of Genentechs Lucentis for all five label indications.