较常用的有Clinical Investigator Inspection List (CLIIL) Search, Dissolution Methods Database Search, Drugs@FDA Search, Orange Book, Product-Specific Guidances for Generic Drug Development Database, Purple Book, 具体介绍如下:(1)Clinical Investigator Inspection List (CLIIL) Search:可查询临床研究的数 ...
User fees, biosimilars on FDA priority list for 2016Erica Cribbs
the FDA outlines its recommendations for biosimilar and interchangeable biosimilar product labeling. The FDA has now approved 42 biosimilar products, including four interchangeable biosimilars, and has gained valuable
"Biosimilar and interchangeable biosimilar products have the potential to reduce health care costs, similar to how generic drugs have reduced costs. Biosimilars marketed in the US typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products,...
In 2016, biosimilars were projected to become “the singlefastest-growingbiologics sector.” American vaccine scientists are salivating over the prospect of proving biosimilarity for futuremRNA vaccines. Though the legal terrain has yet to be consolidated, biosimilarity would guaranteelightning-fa...
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The New England Journal of Medicine reveals list of biosimilar guidelines. In January, Merck BioVentures, a division of Merck that delivers biosimilars, entered into an alliance with Parexel to provide clinical development services. In news reports, it was noted that Merck hopes to have five biosim...
CenterForDrugEvaluationandResearchListofGuidanceDocuments GuidancedocumentsrepresenttheAgency'scurrentthinkingonaparticularsubject.TheydonotcreateorconferanyrightsfororonanypersonanddonotoperatetobindFDAorthepublic.Analternativeapproachmaybeusedifsuchapproachsatisfiestherequirementsoftheapplicablestatutes,regulations,orboth....
An interchangeable biosimilar may be substituted at the pharmacy for the reference product without the intervention of the prescribing healthcare provider, depending on state pharmacy laws. Not all biosimilars are interchangeable. An interchangeable designation is granted by the FDA to only tho...