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About 93 results for "gdufa"

GDUFA fee: 86 generic drug approvals voluntarily withdrawn

Drug companies in the US are carefully evaluating their portfolios to give away approvals for those products that are not commercially viable, as these approvals are not free anymore. Money Control, 3 weeks ago
Office of Generic Drugs Reorganization FirstWord Pharma, 2 days ago

3 images for "gdufa"

Manufacturing Chemist, 2 months ago
Pharma Letter, 4 months ago
Pharma Letter, 4 months ago
FDA News

Will Lagging Generic Approval Rates Increase FDA Backlog?

Generic drug approvals for the first 6 months of fiscal year 2014 are noticeably fewer than for the same period in 2013, despite an abundance of Accelerated New Drug Applications (ANDAs). In the first 6 months of the 2014 fiscal year, the FDA has ...
 Pharmacy Times6 days ago FDAnews Announces -- Expedite Your FDA Generic Drug Approval: Deliver Flawless ANDAs the First Time Webinar, July 15, 2014  Reliance Trust4 weeks ago FDAnews Announces Expedite Your FDA Generic Drug Approval: Deliver Flawless ANDAs the First Time Webinar, July 15, 2014  Digital Media Net4 weeks ago FDAnews Announces — Expedite Your FDA Generic Drug Approval: Deliver Flawless ANDAs the First Time Webinar, July 15, 2014  PRWeb4 weeks ago
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FDA Sets New ANDA Performance Goals for Generics Makers

The FDA has laid out new goals for speeding up its handling of regulatory submissions from generics makers that eventually call for 90 percent of some prior approval supplements to be acted on within six months and ANDA amendments to be acted on ...
 FDA News1 week ago

FDA Publishes Guidance on ANDA Submissions

FDA has released two guidance documents relating to the submission of abbreviated new drug applications (ANDAs). In the guidance documents, FDA explains requirements in regards to the Generic Drug User Fee Amendments of 2012 (GDUFA). Guidance ...
 PharmTech.com1 week ago FDA Releases Draft Guidance on ANDA Submissions  PharmTech.com1 month ago

eSubmitter Enhancements and Fixes for Version 2.08.01

Provided below is a listing of recent updates to the application software in reverse chronological order by version number. For updates prior to this list, consult the Application History Archive . Version 2.08.01 - Released July 7, 2014 ...
 U.S. Food and Drug Administration2 weeks ago

US pharma companies want dialogue with India on IPRs

T Arguing that global pharma companies share the same goal of "patient first" with that of the Government of India, corporate executives attending the day-long "US-India BioPharma and Healthcare Summit" organised by the USA-India Chamber of ...
 Moneycontrol.com3 weeks ago
BioSpace

Selecting the Right Business Partner in Today's Generics Climate

Interview With Richard DiCicco, Chairman With Harvest Moon Pharmaceuticals, on Key Topics to Be Discussed at the Upcoming marcus evans 7th Product & Pipeline Enhancement for Generics Conference, on July 30-31 at the Hilton Alexandria Old Town, ...
 BioSpace4 weeks ago
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Pharma Contract Manufacturing: World Market Outlook 2013-2023

LONDON Report Details Contracted drug production - discover trends and segments with highest revenue potential Where's outsourced pharma manufacturing heading? Visiongain's updated report predicts that industry's revenues from 2013. There you ...
 Stock Nod1 month ago
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Bulk Pharmaceuticals Task Force Alarmed at Reduction in Compliance Inspections

The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA) , issued a letter to the Food and Drug Administration (FDA) asking that the agency ensure the frequency of inspections for any ...
 FiercePharmaManufacturing1 month ago US Bulk Pharmaceuticals Task Force alarmed at reduction in compliance inspections  Manufacturing Chemist1 month ago BPTF Warns FDA on Reduced API Manufacturer Inspections  PharmTech.com1 month ago
Packaging Machinery Technology

A Review of Regulations and Developments in GMP and Supply Chain Integrity of Active Pharmaceutical Ingredients

By Sia Chong Hock, Katherine Loh Kai Xin, Vimal Sachdeva and Chan Lai Wah Without APIs, finished products (FPs) are nothing more than placebos. Active Pharmaceutical Ingredients (APIs) are defined as substances intended to be used in the ...
 Packaging Machinery Technology1 month ago
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