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Federal Register

FDA Webinar on OTC Monograph User Fees

Federal Register notice: FDA announces an 8/23 Webinar to provide stakeholders with a status update on the process of FDA and industry discussions on ...

Medical Devices

Public Meeting on 3D Printing of Anatomic Models

CDRH and the Radiological Society of North America 3D Printing Special Interest Group announce an 8/31 joint meeting on the clinical use of 3D printed...

Human Drugs

Coherus Wants Delay in Neulasta Case Discovery

Patterson Belknap attorneys say that Coherus BioSciences is asking a federal court to delay discovery in a Neulasta patent dispute with Amgen until th...

Medical Devices

Medtronic Gains Approval for Avalus Aortic Valve

FDA approves a Medtronic PMA of its new Avalus pericardial aortic surgical valve for treating aortic valve disease.

Federal Register

Animal Drug User Fee Rates for 2018

Federal Register notice: FDA announces the fee rates and payment procedures for fiscal year 2018 generic new animal drug user fees.

Federal Register

2018 User Fee Rates for Drug Compounders

Federal Register notice: FDA announces the fiscal year 2018 rates for the establishment and re-inspection fees related to entities that compound human...

Human Drugs

FDA, TG Therapeutics Agree on Special Protocol for MS Studies

FDA and TG Therapeutics reach an agreement on a special protocol assessment on the design of two Phase 3 clinical trials for TG-1101 (ublituximab), a ...

Human Drugs

Generic Drug Prices Increasing Over Time

A National Bureau of Economic Research working paper says more study into how much generic drug prices have increased over time is warranted.

Human Drugs

FDA Accepts AstraZeneca NDA for Acalabrutinib

FDA accepts for priority review an AstraZeneca NDA for acalabrutinib, a highly-selective Bruton tyrosine kinase inhibitor for treating patients with r...

Human Drugs

Imbruvica Indication Expanded to cGVHD

FDA approves Pharmacyclics Imbruvica for a new indication to treat chronic graft versus host disease after failure of one or more treatments.