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About 49 results for "gdufa"

GDUFA and You Conference

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

2 images for "gdufa"

Pharma Letter, 1 month ago
Pharma Letter, 1 month ago
Pharma Letter

US GPhA member support for GDUFA promise and progress

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 Letter2 months ago Generic Industry Launches GDUFANow.org, New Digital Library Highlights GPhA Member Support for GDUFA Promise and Progress  Pharmacy Choice2 months ago GPhA Announces 2014 Board of Directors  Equities.com2 months ago

FDA, GPhA Reaffirm Shared Commitment to GDUFA

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 Pharma2 months ago

PCI SYNTHESIS : Co-Sponsors Third Annual Massachusetts CRO/CMO Symposium

- 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 Traders1 day ago PCI Synthesis Co-Sponsors Third Annual Massachusetts CRO/CMO Symposium  BioSpace1 day ago
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What Time Is It?

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 Magazine1 week ago
Business Standard India

Efficiency is key, not product portfolio

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 India1 month ago

Akorn's CEO Discusses Q4 2013 Results - Earnings Call Transcript

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 Alpha1 month ago Akorn Reports 2013 Fourth Quarter and Year-End Financial Results  BusinessWeek1 month ago Akorn, Inc. : Akorn Reports 2013 Fourth Quarter and Year-End Financial Results  4 Traders1 month ago
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New Fees Made FDA Less Effective on Generic Drug Approvals, Says GPhA Chairman

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 Executive1 month ago IDMA urges US FDA to reduce Generic Drug User Fee on Indian pharma exporters  PharmaBiz1 month ago US FDA to reduce backlog of generic drug applications, increase inspections  PharmaBiz2 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 Choice1 month ago
In-Pharmatechnologist

US FDA's Hamburg offers few details on trip to India

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-Pharmatechnologist1 month ago US FDA recruiting more inspectors in India as Hamburg pushes need for quality  In-Pharmatechnologist2 months ago FDA concludes Indian visit with pledge to focus on quality  Pharma Letter2 months ago Hamburg's India trip was about Taj, quality and pharma  Business Today India2 months ago
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