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, 1 month 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, 2 months ago Generic Industry Launches GDUFANow.org, New Digital Library Highlights GPhA Member Support for GDUFA Promise and Progress Pharmacy Choice, 2 months ago GPhA Announces 2014 Board of Directors Equities.com, 2 months 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 months ago
- PCI Synthesis, a Boston-based Contract Manufacturing Organization (CMO) that manufacturers new chemical entities (NCEs), generic active pharmaceutical ingredients (APIs), and complex specialty chemicals, is one of key sponsors of the third annual ...4 Traders, 1 day ago PCI Synthesis Co-Sponsors Third Annual Massachusetts CRO/CMO Symposium BioSpace, 1 day ago
Time for generic pharma's leadership By in Chief & Gary Ritchie, Contributing Editor Apr 15, 2014 It's no secret the generic pharmaceutical industry is in a time of change and dramatic growth. The patent cliff, a major driver of this ...Pharmaceutical Manufacturing Magazine, 1 week ago
The Indian pharmaceutical industry is in the midst of several changes that will require many companies to realign their business model. For the past several years, companies have benefited from the large number of drugs that have gone off-patent.Business Standard India, 1 month ago
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, 1 month ago Akorn Reports 2013 Fourth Quarter and Year-End Financial Results BusinessWeek, 1 month ago Akorn, Inc. : Akorn Reports 2013 Fourth Quarter and Year-End Financial Results 4 Traders, 1 month 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 month ago IDMA urges US FDA to reduce Generic Drug User Fee on Indian pharma exporters PharmaBiz, 1 month ago US FDA to reduce backlog of generic drug applications, increase inspections PharmaBiz, 2 months 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 month 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 month ago US FDA recruiting more inspectors in India as Hamburg pushes need for quality In-Pharmatechnologist, 2 months ago FDA concludes Indian visit with pledge to focus on quality Pharma Letter, 2 months ago Hamburg's India trip was about Taj, quality and pharma Business Today India, 2 months ago
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