27. April 2018
The US Food and Drug Administration (FDA) approved over 700 generic drugs in 2015 alone, which was the highest to date, based on a report published by the FDA’s Office of Generic Drugs (OGD). The report also stated that the Agency approved 99 generic drugs in December 2015, which reflected FDA’s accomplishment report to Congress from March 2016.
27. June 2016
Abstract Pharmaceutical excipients contribute unique functionalities to formulations, thereby largely determining the drug products quality and influencing its safety and efficacy. Changes and variations of excipients in licensed products are, therefore, placed under strict regulatory control. This article presents a proposed regulatory mechanism for pharmaceutical excipients by United States of Food and Drug Administration (USFDA). In Unites States, excipients are regulated by United States of...