arch 2014 Conference Lake Buena Vista, Florida, US The Generic Drug User Fee Amendments (GDUFDA) 2012 is landmark drug legislation designed to speed the delivery of safe, high-quality and affordable generic drugs to the public and reduce ... Manufacturing Chemist, 3 days ago
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The US Food and Drug Administration Office of Generic Drugs acting director Kathleen Uhl, highlighted the industry and FDA's shared commitment to Generic Drug User Fee Act (GDUFA) milestones and approaching metrics in her keynote address at the GPhA ...Pharma Letter, 1 week ago Generic Industry Launches GDUFANow.org, New Digital Library Highlights GPhA Member Support for GDUFA Promise and Progress Pharmacy Choice, 1 week ago Statement by Ralph G. Neas, President and CEO, Generic Pharmaceutical Association, Applauding FDA for Making GDUFA a Public Health Priority,... Pharmacy Choice, 1 month ago GPhA Announces 2014 Board of Directors Equities.com, 2 weeks ago
You currently are not registered for any FirstWord Pharma services. Register to FirstWord Pharma for free access to 10 articles every 30 days: You can also: Wait 30 days for your content allowance to be renewed. Sign up for a free trial to ...FirstWord Pharma, 2 weeks ago
A five year plan describes how the Food and Drug Administration (FDA) proposes to meet the information technology (IT) goals of the Generic Drug User Fee Act (GDUFA) Authorization Performance Goals and Procedures Fiscal Years 2013 through FY 2017.Laboratory Equipment, 1 month ago Featured Report: FDA Aims to Meet IT Goals Laboratory Equipment, 1 month ago
The FDA has made an uneasy transition to the digital era. Congress' watchdog has cataloged its failings, taking potshots at incomplete databases, slow-moving modernization efforts and the lack of a clear IT strategy in recent years. Now, the FDA has ...Fierce BioMarkers, 1 month ago
-Reports Q4 Revenue of $85.0 million and Q4 Adjusted EPS of $0.14- LAKE FOREST, Ill.--(BUSINESS WIRE)--Mar. 3, 2014-- Akorn, Inc. (NASDAQ: AKRX), a niche generic pharmaceutical company, today reported financial results for the fourth quarter and ...BusinessWeek, 4 days ago Akorn, Inc. : Akorn Reports 2013 Fourth Quarter and Year-End Financial Results 4 Traders, 4 days ago
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Operator Good morning and thank you for joining Akorn's Incorporated 2013 Fourth Quarter and Year End Conference Call. If you not have yet had a chance to read the earnings release you may access it through the Investor Relations section at ...Seeking Alpha, 3 days ago Sagent Pharmaceuticals' CEO Discusses Q4 2013 Results - Earnings Call Transcript Seeking Alpha, 3 weeks ago
Actions don't speak louder than words in dealing with FDA's backlog of generic drug applications, says newly-elected GPhA Board Chairman Craig Wheeler. When the Generic Drug User Fee Act (GDUFA) was signed into law on July 7, 2012, its primary ...Pharmaceutical Executive, 1 week ago IDMA urges US FDA to reduce Generic Drug User Fee on Indian pharma exporters PharmaBiz, 1 week ago US FDA to reduce backlog of generic drug applications, increase inspections PharmaBiz, 2 weeks ago
Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives; Public Hearing; Request for Comments
Notification of public hearing; request for comments. CFR Part: "21 CFR Part 15" Citation: "79 FR 10740" Document Number: "Docket No. FDA-2013-N-0402" Page Number: "10740" "Proposed Rules" SUMMARY: The Food and Drug Administration ...Pharmacy Choice, 1 week ago
In a conference call Friday, FDA Commissioner Margaret Hamburg explained the importance of her recent trip to India, calling for more harmonization between the regulators. The importance of the trip rests with the fact that India provides about ...In-Pharmatechnologist, 1 week ago US FDA recruiting more inspectors in India as Hamburg pushes need for quality In-Pharmatechnologist, 2 weeks ago FDA concludes Indian visit with pledge to focus on quality Pharma Letter, 2 weeks ago Hamburg's India trip was about Taj, quality and pharma Business Today India, 2 weeks ago
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