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  • New Biologic Sterility Regulation Issued by FDA

    The US Food and Drug Administration (FDA) is announcing its amendment of existing sterility test requirements for biological products, which it said will provide greater flexibility for manufacturers and encourage the use of cutting-edge technologies to assure the safety of biological products. In its 2 May Federal Register posting entitled Amendments to Sterility Test Requirements for Biological Products , FDA said its rule is "intended to promote improvement and i...
  • BIO Analysis: Resubmissions After Third Round of FDA Review Not Worth the Effort

    An analysis by the Biotechnology Industry Organization (BIO) of 748 new drug applications (NDAs) and biologics license applications (BLAs) shows a nearly 20% increase in the rate of approvals for second-round submissions in response to a first-round complete response letter (CRL). The analysis, which tracked NDA and BLA submissions made between 2005 and 2010, shows a 55% approval rate for first-round submissions. The total approval rate jumped nearly 20% to 74.6% after ...