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.
04. January 2018
The year gone by saw the highest number of generic drug approvals by the US Food and Drug Administration (FDA), along with the most ever novel drugs (46); the most ever novel devices, and the first ever gene therapies. In 2017, 46 new molecular entities (NMEs) were approved by the FDA , and that excludes the pathbreaking CAR-T and gene therapies.
03. November 2017
The estimated timeline for a drug product from discovery to market is 10 to 15 years. However, less than 12 percent of drug candidates that enter clinical trials will ultimately receive FDA approval. The Orphan Drugs Act of 1983 ensured that there were adequate incentives offered to drug developers working on therapies to treat fewer than 200,000 patients in U.S.
24. October 2016
Abstract The rapidly growing medical expense going with aging population in Japan requires the use of generic products derived from off-patent active pharmaceutical ingredients (APIs) formulations to reduce the financial burden for the national health insurance system, while at the same time avoiding undermining the quality of medical care. This article provides an overview of the regulatory approaches available to confirm the quality of generic products and gain their greater acceptance by...
28. October 2015
Generics may differ from their reference product in terms of inactive ingredients, e.g. excipients, provided this does not affect the safety and efficacy of the product. Authors from the Office of Generic Drugs at the US Food and Drug Administration (FDA) highlight general toxicology concerns caused by such formulation differences between generic and originator drugs [1]. More
25. January 2015
By Gareth MacDonald+Gareth MACDONALD, 23-Jan-2015BASF will spend €56m ($62m) to increase production capacity for the excipient PVP by expanding existing plants and introducing manufacturing capabilities at its facility in Shanghai, China. http://www.in-pharmatechnologist.com/Ingredients/BASF-to-take-on-Asian-PVP-producers-and-target-generics-firms-with-new-capacity-in-China