• Regulatory NewsRegulatory News

    Time for FDA to Release Complete Responses Letters? Debate Reignites

    The idea of the US Food and Drug Administration (FDA) releasing complete response letters (CRLs) resurfaced this week as Sarepta Therapeutics received a CRL but refused to make public any portion of it. Following a question on transparency at an event Thursday , Sarepta CEO Doug Ingram said that not releasing the text of the CRL was “a service to the community” and that FDA might not want a confidential letter to be released. “The basis for the CRL is exactly as I've s...
  • Regulatory NewsRegulatory News

    Meeting With FDA After a CRL: Draft Guidance on What to Expect

    The US Food and Drug Administration (FDA) on Friday released new draft guidance for industry on the 30-minute post-complete response letter (CRL) meetings between FDA and abbreviated new drug application (ANDA) applicants to help clarify deficiencies. The guidance, released as part of the agency's second Generic Drug User Fee Amendments (GDUFA II) commitments, offers details for companies on what a meeting request should include, how the requests will be assessed, ...
  • Regulatory NewsRegulatory News

    FDA Transparency: Gottlieb Outlines What’s Coming

    FDA Commissioner Scott Gottlieb has been at the forefront of the Washington, D.C. conference circuit this week discussing new work that the agency he leads will undertake, with discussions Thursday at a Politico event, a speech Wednesday at the Friends of Cancer Research, a speech Monday at RAPS' Convergence and a speech last week at the National Health Research Forum. On Thursday, Gottlieb highlighted a few upcoming moves that the agency plans to make in terms of t...
  • Regulatory NewsRegulatory News

    FDA Researchers Make Case for More Transparency When Drugs are Rejected

    When the US Food and Drug Administration (FDA) finds reason not to approve a drug, it issues what is known as a Complete Response Letter (CRL) indicating its reasons for withholding approval and explaining which additional data might support an approval decision. Publicly-traded companies almost always communicate the issuance of these letters to the public, and generally summarize the points made by FDA in the letter. But how often do those companies tell the whole trut...
  • Timing of Complete Response Letter Disclosure Leads to Investigation into Novo Nordisk

    • 10 December 2013
    Danish pharmaceutical manufacturing giant Novo Nordisk is the target of a new investigation into whether the company provided adequate disclosure to its investors regarding the status of two drug products it had sought approval for from the US Food and Drug Administration (FDA). Background The investigation, first revealed by Novo in a 10 December 2013 press statement, regards the complete response letters (CRLs) sent by FDA to Novo on 8 February 2013 for two products, ...
  • FDA Moves to Reduce Backlog of ANDAs

    The US Food and Drug Administration (FDA) is moving to clear a massive backlog of abbreviated new drug applications (ANDAs), used by companies looking to market generic versions of FDA-approved products, in advance of new resources expected under a duo of user fee bills expected to be passed by the Congress within the next few months. In a 13 June Federal Register posting, the agency said it wants to disregard any ANDA which it deems to have been abandoned by virtue of...
  • 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 ...