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As part of the Generic Drug User Fee Amendments Reauthorization (GDUFA II) recently agreed with industry , the US Food and Drug Administration (FDA or Agency) has released guidance outlining how sponsors can qualify for shorter review times for priority generics.
Original Article: FDA to speed up review of priority genericsNEXT ARTICLE
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...