FDA – 3Sixty Pharma Solutions LLC https://3sixtypharma.com Nimble support with experienced helping hands. Sat, 13 Jan 2018 20:01:15 +0000 en-US hourly 1 https://i0.wp.com/3sixtypharma.com/wp-content/uploads/2018/05/cropped-cropped-3sixty_logo_web-1.png?fit=32%2C32&ssl=1 FDA – 3Sixty Pharma Solutions LLC https://3sixtypharma.com 32 32 111242915 Biosimilar nomenclature: Deadline August 2 for comments on FDA’s OMB information request https://3sixtypharma.com/2016/06/02/deadline-july-2-fdas-omb/ Thu, 02 Jun 2016 17:32:22 +0000 https://3sixtypharma.com/?p=583 [...]]]> Meaningful suffix may be in for U.S. biologics, biosimilars

 

 

FDA Pushes Back Comment Period for Biosimilar Labeling

Just released: new deadline August?2 for information collection request it submitted to the White House Office of Management and Budget (OMB)

 

 

Additional Reading

FDA approves Inflectra, a biosimilar to Remicade

A Rocky Start for Biosimilar Inflectra?

FDA Approves INFLECTRA? (Biosimilar Infliximab), The First U.S. Biosimilar Monoclonal Antibody, For All Eligible Indications

Sandoz launches ZarxioTM (filgrastim-sndz), the first biosimilar in the United States

FDA Information on Biosimilars

Biosimilar switching not suitable for all patients

 

 

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