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
Draft Guidance for Industry on Abbreviated New Drug Application Submissions--Prior Approval Supplements Under the Generic Drug User Fee Amendments of... - Pharmaceutical & Medical Packaging News, 1 week ago
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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 Times, 6 days ago FDAnews Announces -- Expedite Your FDA Generic Drug Approval: Deliver Flawless ANDAs the First Time Webinar, July 15, 2014 Reliance Trust, 4 weeks ago FDAnews Announces Expedite Your FDA Generic Drug Approval: Deliver Flawless ANDAs the First Time Webinar, July 15, 2014 Digital Media Net, 4 weeks ago FDAnews Announces — Expedite Your FDA Generic Drug Approval: Deliver Flawless ANDAs the First Time Webinar, July 15, 2014 PRWeb, 4 weeks ago
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 News, 1 week ago
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 Guidance ...PharmTech.com, 1 week ago FDA Releases Draft Guidance on ANDA Submissions PharmTech.com, 1 month ago
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 Administration, 2 weeks ago
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.com, 3 weeks ago
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, ...BioSpace, 4 weeks ago
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 Nod, 1 month ago
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 ...FiercePharmaManufacturing, 1 month ago US Bulk Pharmaceuticals Task Force alarmed at reduction in compliance inspections Manufacturing Chemist, 1 month ago BPTF Warns FDA on Reduced API Manufacturer Inspections PharmTech.com, 1 month ago
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 Technology, 1 month ago
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