• Regulatory NewsRegulatory News

    Best Practices for IND Sponsor Communications: FDA Finalizes Guidance

    The US Food and Drug Administration (FDA) last week finalized guidance from 2015 on the best practices for communications between investigational new drug application (IND) sponsors and FDA. The guidance describes what to expect in milestone meetings (i.e. pre-IND, end-of-Phase 1 and Phase 2 and pre-NDA/BLA [new drug application/biologics license application] meetings) and how sponsors and FDA work collaboratively during the drug development process. In addition, ...
  • Regulatory NewsRegulatory News

    New Draft Guidance on Best Practices for IND Communications Between Sponsors, FDA

    Investigational new drug application (IND) sponsors communicating with the US Food and Drug Administration (FDA) during the various drug development phases now will have a new set of best practices to consult with prior to their meetings thanks to draft guidance released by FDA on Friday. The communications between FDA and industry are often opportunities to share cirtical information on clinical trials and for the agency to provide advice on trial design, dose selection...
  • Regulatory NewsRegulatory News

    FDA Revises Policies on Obtaining Informed Consent in Clinical Trials

    A new draft guidance document issued by the US Food and Drug Administration (FDA) is meant to eventually replace a 16-year-old guide outlining the regulator's views on informed consent. Informed Consent: The Basics As FDA explains in the draft guidance, Informed Consent Information Sheet , when most people think about the process of obtaining consent, they think of it as obtaining written consent from the subject to participate in a medical study. But FDA says this...
  • FDA Blasts Clinical Investigation in Warning Letter, Saying Deviations Impacted Study Validity, Integrity

    Failure to follow the agreed-upon protocol for a clinical trial for an investigational pain pill product has earned a clinical investigator a Warning Letter from the US Food and Drug Administration (FDA), the agency has announced. Deviating from Protocols The letter to Henry Frazer of Montgomery, AL-based Drug Research and Analysis Corporation said FDA investigators had observed "objectionable conditions" during a Bioresearch Monitoring (BIMO) program checkup on Fraze...
  • EMA Releases Updated Final Guideline on Active Substance Master Files

    A new final guideline published on 13 July 2012 by the European medicines Agency (EMA) updated the Active Substance Master File (ASMF) Procedure -its first upgrade since its formation in 2006. The ASMF procedure, formerly known as the European Drug Master File (EDMF) procedure, is used to protect confidential intellectual property information while allowing regulatory agencies to access a more complete picture regarding how an active substance is manufactured. Both EMA a...
  • Federal Agencies Team Up to Issue Draft Guidance on IRB Transfers

    The US Food and Drug Administration (FDA) has released a draft guidance intending to instruct sponsors, clinical investigators (CIs) and Institutional Review Boards (IRBs) on best practices for transferring clinical trial oversight to a new IRB. The proposed guidance harmonizes regulatory interpretations between FDA and the US Department of Health and Human Services' Office for Human Research Protections (OHRP). The agencies said in a Federal Register statement they pl...
  • Minor Changes Planned For User Fee Application Forms

    • 17 May 2012
    The cover sheet used by pharmaceutical and biotechnology companies when submitting their user fees scheduled to receive an upgrade, the US Food and Drug Administration (FDA) revealed in a Federal Register posting. The sheets are currently mandatory for companies, which pay the agency fees in return for having their applications reviewed under the terms of the Prescription Drug User Fee Act (PDUFA) . "Because the submission of user fees concurrently with applications a...