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Info on CMC Postapproval Changes Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on a guidance on ...

Nanotherapeutics Enrolls First Patient in Cervical Cancer Drug Trial

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Nanotherapeutics enrolls its first patient in a Phase 2 clinical trial of Triapine in combination with cisplatin and radiation in ...

Info on BLA General Licensing Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection on general licensing provisions for BLAs to the Office of Management an...

FDA Submits Info on IND Safety Reporting to OMB

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Federal Register Notice: FDA submits to the Office of Management and Budget a proposed collection of information on investigationa...

Info on Device Premarket Approval Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on premarket approval of medical devices to the Office o...

FTC Sues HGC Marketer for Deceptive Advertising

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The Federal Trade Commission sues the owner of two companies marketing HCG diet products for deceptive advertising.

Label Change on Potiga Over Eye Risks

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FDA approves label changes to GlaxoSmithKlines anti-seizure drug Potiga (ezogabine) to underscore risks of abnormalities to the re...

WLF Backs Device Group on 510(k) Complaints

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Washington Legal Foundation says it supports an earlier citizen petition criticizing the way FDA is changing the 510(k) program.

Pentax Medical Recalls Gas/Water Valves

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Pentax Medical has recalled 76 Pentax Gas/Water Valves, model OF-B194, that are used with the companys GI Video Endoscopes.

Hatchtech Plans NDA Submission for Lice Treatment

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Hatchtech says it is planning a Phase 3 trial involving head lice treatment DeOvo (Ha44) to support an NDA submission planned for ...