As part of its push to increase generic competition, the US Food and Drug Administration (FDA) on Friday published 74 product-specific guidance, including 22 new and 52 revised guidance.
Read more : https://www.raps.org/news-and-articles/news-articles/2019/2/generic-drugs-fda-releases-74-product-specific-gu
The U.S Food and Drug Administration (FDA) has created a new pathway for the accelerated review of generic drug applications. The plan is part of the regulatory agency's efforts to increase competition and lower drug prices in the United States.
Read more : https://www.modernhealthcare.com/article/20190225/NEWS/190229948
The EU is adopting new rules which should boost the competitiveness of EU producers of generic medicines and biosimilar products.
Read more : https://www.consilium.europa.eu/en/press/press-releases/2019/02/20/eu-measures-in-support-of-generic-pharmaceuticals-producers/
Teva Pharmaceutical (TEVA) guided for a small fall in revenue in its North American generics business from $4.1 billion in 2018. While the company reported a stabilization in revenue in its North American generics business in 2018, it’s expected to be unfavorably affected by generic erosion and falls in sales volumes partly offset by new product launches in 2019.
Read more : https://www.centerforbiosimilars.com/news/the-mostread-contributor-articles-of-2018
US FDA issues draft guidance for its competitive generic therapies pathway, providing drug makers with clarity on the designation and calling on the industry for more generic competition.
Read more : https://www.in-pharmatechnologist.com/article/2019/02/19/us-fda-issues-draft-guidance-on-generic-approvals