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Ciprofloxacin Hydrochloride DMF-Drug Master File
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Month: November 2016
Example DMF Drug Master File
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FDA’s Policy On Communicating Drug Approval Information
FDA’s has made effective manual procedure and policy for communicating drug approval information. Considering interest of industry and FDA including press an other international...
Purple Book For Licensed Biological Products
FDA has published purple book containing list of licensed biological products with reference product, and biosimilarity. The lists includes the date on which biological product...
EDQM Updated CEP Revision And Renewal Guideline.
EDQM update their guideline for Revision and Renewal of CEP. The EDQM has revised the “Guideline on requirements for revision/renewal of certificates of suitability to the...
Is Ebola Making FDA Concerned ??
In July ‘14 FDA in their compliance guidance for manufacture of drugs paid added attention to the NTDs. The Neglected Tropical Diseases. Most of these diseases are confined to...