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  • Regulatory NewsRegulatory News

    Elemental Impurities Deadline Contributes to Spike in CRLs for Generic Drugmakers

    New generic drug applications are not winning a lot of approvals from the US Food and Drug Administration (FDA) so far in January 2018, and at least part of the reason for an increase in complete response letters (CRLs) is a new requirement from the US Pharmacopeia (USP). Lachman Consultants' Bob Pollock, a former official in FDA’s Office of Generic Drugs, first discussed the low number of abbreviated new drug application (ANDA) approvals in January – just four ap...
  • Regulatory NewsRegulatory News

    FDA to Begin Issuing Deficiency Review Letters to Generic Drugmakers

    The US Food and Drug Administration (FDA) on Friday published draft guidance that would establish a new type of letter the agency sends to generic drugmakers to provide applicants with preliminary thoughts on possible deficiencies of an abbreviated new drug application (ANDA). Thanks to the recently reauthorized Generic Drug User Fee Amendments (GDUFA II), FDA will issue Deficiency Review Letters (DRLs) and information requests (IRs) to obtain further information ...
  • Regulatory NewsRegulatory News

    FDA Transparency: Agency’s Hands Tied by its own Regulations

    Ask a US Food and Drug Administration (FDA) official how many biosimilar applications are actually under review, or the details of a recent Complete Response Letter (CRL), and he or she will explain how the agency cannot offer any more details than what is already publicly known, even if what has been made public is not aligned with reality. And in some areas, like with CRLs, which are letters sent by FDA when medical product applications cannot be approved, research fr...
  • Regulatory NewsRegulatory News

    FDA Rejects Highest Number of Monthly Generic Drug Applications Ever

    The common refrain that the US Food and Drug Administration (FDA) has been approving an exorbitantly high number of drug applications for generic drugs, known as abbreviated new drug applications (ANDAs), to increase market competition in recent years is slowing down in recent months. In the latest release of raw data on Tuesday of approvals and complete response letters (CRLs), also known as rejections, for ANDAs, FDA said that in the month ending 16 April 2016, it...