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As part of its ongoing efforts to encourage biosimilars, the FDA issued draft guidance yesterday on the agency’s abbreviated review pathway for sponsors of biosimilars with more limited conditions of use than the reference product.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
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended fifteen drugs for approval at its first meeting of the year, including four generics and one biosimilar. Read More
Priority review vouchers (PRVs) may have little to no effect on drug development, the Government Accountability Office (GAO) concluded in a report released on Friday — although some drugmakers surveyed said otherwise. Read More