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Praise for Biosim User Fee Agreement

[ Price : $8.95]

Three industry stakeholders praise the agreement reached for reauthorization of the Biosimilars User Fee Act.

FDA Moves to Improve Hearing Aid Accessibility

[ Price : $8.95]

FDA says it will no longer require medical evaluations and signed waivers before consumers purchase a hearing aid, and it is consi...

CFSAN Posting Adverse Event Data Files

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Federal Register Notice: FDA makes available data extracted from adverse event reports from 2004 to the present for food (includin...

Trump Team Looking at Non-Medical Person to Lead FDA

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President-elect Donald Trumps reportedly considers a Silicon Valley venture capital manager to take the helm at FDA.

FDA Determines Regulatory Review Period for Mercks Gardasil 9

[ Price : $8.95]

Federal Register Notice: FDA determines the regulatory review period for Mercks Gardasil 9 (human papillomavirus 9-valent vaccine,...

FDA Issues Lengthy 483 to Sun Pharmaceutical

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Bloomberg News reports that a recent FDA inspection at Suns plant in Halol, India, resulted in a 14-page FDA-483.

Medtronic, Fitbit Partner on Diabetes Tracker

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Medtronic and Fitbit partner on a mobile app to help Type 2 diabetes patients track glucose levels and physical activity.

Voluntis Diabetes Management Tool Cleared

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FDA grants Voluntis 510(k) clearance for Insulia, a digital solution intended to support the effective management of Type 2 adult ...

Kitov Pharma Planning NDA for Combo of 2 Pfizer Drugs

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Kitov Pharmaceuticals Holdings completes FDA-required stability testing on nine pivotal batches of KIT-302, which the company says...

Senate Passes Cures Act and Sends to Obamas Desk

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One week after the House passed the 21st Century Cures Act, the Senate votes 94 to 5 to pass the bill, and now sends it to Preside...