• Regulatory NewsRegulatory News

    India to Formalize Pre-Submission Meetings

    In a move that promises to bring greater clarity to India’s regulatory process for pharmaceutical products, India’s regulator has announced plans to formalize a process for pre-submission meetings (PSMs). In a notice dated 28 January 2015, the Central Drugs Standard Control Organization (CDSCO) laid out proposed steps for the process. Purpose and Precedent PSMs are designed to help companies ensure their drug application submissions conform to legal, regulatory and sc...
  • Regulatory NewsRegulatory News

    Breaking Bottlenecks: FDA Clarifies Tool for Expediting Drug Development (Corrected)

    The US Food and Drug Administration (FDA) is trying to clarify how industry can request a meeting of the agency's Critical Path Initiative (CPI), a decade-old effort to accelerate drug development through the use of common standards. Correction: A previous iteration of this article suggested that FDA's effort under the Critical Path Initiative, as well as its Critical Path Innovation Meetings (CPIM), were connected with the Critical Path Institute (C-Path)—a public-priv...
  • FDA Finalizes Massive Rewrite of Device Pre-Submission Guidance

    US Food and Drug Administration (FDA) officials on Tuesday released an extensive guidance document aimed at clarifying elements of the medical device pre-submission program, now used to provide manufacturers and application sponsors with feedback and advice. Those meetings are crucial to identifying, clarifying and mitigating any issues with a clinical trial or full medical device application, which can be delayed or derailed entirely by regulatory issues. The meetings, ...
  • In Unusual Move, FDA Withdraws OMB Submission to Focus on Changes to Device Program

    If you're waiting for the US Food and Drug Administration's (FDA) guidance on planned changes to its medical device pre-submission meeting program, you may have to wait a bit longer. In a highly unusual Federal Register notice on 4 January 2013, FDA explained that it was withdrawing an earlier 11 December 2012 Federal Register notice in which it announced that it had submitted for review the guidance document The Pre-Submission Program and Meetings with FDA Staff ...
  • Survey: FDA 510(k) Submissions Garner Most Concern Among Device Professionals

    A new survey of medical device professionals conducted by the publication Medical Device and Diagnostic Industry found that 510(k) submissions garner the most concern among all regulatory issues, followed closely by the pre-submission process to the US Food and Drug Administration (FDA). The survey of 283 medical device professionals asked what two regulations and regulatory processes were of the most concern. Thirty-six percent of respondents indicated 510(k) submi...