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Submissions should information from the reference product’s labeling on the proposed conditions of use, along with “appropriate modifications.” Read More
The approval makes Audenz the first adjuvanted, cell-based influenza vaccine designed to protect against influenza A in the event of a pandemic. Read More
As part of its ongoing efforts to encourage biosimilars, the FDA issued draft guidance yesterday on the agency’s abbreviated review pathway for sponsors of biosimilars with more limited conditions of use than the reference product. Read More
The FDA cited Sunstar for serious violations at a manufacturing facility in China, issuing the firm a warning letter for failing to test incoming drug components and finished products, among other violations. Read More