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  • Regulatory NewsRegulatory News

    FDA warns COVID trial sponsor for failing to submit IND

    The US Food and Drug Administration (FDA) last month warned a clinical trial sponsor for failing to submit an investigational new drug (IND) application for a study of a product to treat COVID-19.   In its warning letter to KDunn and Associates, P.A. dba HealthQuilt, FDA said it observed “objectionable conditions” during an August inspection related to a trial the company sponsored titled “An Open-Label Pilot Study to Assess the Efficacy and Safety of [redacted] in Sub...
  • Regulatory NewsRegulatory News

    Drugmakers Can Now Submit Pre-Assigned Number Requests via CDER’s Portal

    • 19 August 2019
    • By  
    Beginning Monday, prospective applicants can submit pre-assigned number requests for four additional application types: new drug application (NDA), investigational new drug (IND) application, biologic license application (BLA) and drug master file (DMF), via the Center for Drug Evaluation and Research (CDER)’s NextGen Portal.   The pre-assigned number requests were previously made via email. But now the firms submitting such applications can use the portal, which is a ...
  • Regulatory NewsRegulatory News

    Rare Disease Pre-IND Meetings: FDA Offers Draft Guidance

    The US Food and Drug Administration (FDA) on Monday released new draft guidance to assist sponsors of  treatments for rare diseases in planning and conducting more efficient and productive pre-investigational new drug application (pre-IND) meetings. Specifically, the guidance discusses issues commonly encountered in the early phases of rare disease drug development. “Our experience shows that early and substantive engagement with FDA review teams can help increase th...
  • 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

    FDA Explains Emergency Expanded Access Application Process

    The US Food and Drug Administration (FDA) has laid out the process by which doctors can access an investigational drug for treatment in an individual patient in an emergency situation, both during and after normal business hours in a new Manual of Policies and Procedures. The release of the MAPP coincides with a bill passed in the Senate and making its way through the House that aims to ease the process by which terminal patients can access such investigational dr...
  • Feature ArticlesFeature Articles

    IND Application Fast Facts

    This article provides information companies need when filing an Investigational New Drug (IND) a pplication  with the US Food and Drug Administration (FDA) to help make the application process more efficient. It addresses common questions and concerns that develop across multiple companies and multidisciplinary groups. When is there a 30-day FDA review? After filing an IND application with FDA, there is a mandatory 30-day review period. 1 The purpose of this review i...
  • Regulatory NewsRegulatory News

    Companies Producing Drugs Only for INDs Exempt From FDA Registration

    The US Food and Drug Administration (FDA) on Monday published a correction to a recent final rule on registering foreign and domestic manufacturing establishments, clarifying that a company producing solely products for investigational new drug (IND) applications is exempt from registration. The more than 200-page final rule released in late August requires the electronic submission of the registration and listing information for all drug, active pharmaceutical ingredi...
  • Regulatory NewsRegulatory News

    Microbial Vectors Used for Gene Therapy: FDA Offers Final Guidance

    The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research this week issued final guidance for investigation new drug (IND) submissions for microbial vectors used for gene therapies (MVGTs) in early-phase clinical trials. The 27-page final guidance follows a draft issued in October 2015 and is meant to supplement: “Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human...
  • Regulatory NewsRegulatory News

    Drug Safety Reports Still Uninformative, FDA Officials Say

    Most expedited safety reports for investigational new drugs (INDs) are uninformative, despite recent efforts to improve the quality of such reports, FDA officials wrote in a recent research article. Sponsors are required to compile all adverse events for drugs they are studying in annual safety reports. If an adverse event is serious, unexpected or suspected to be caused by the drug being studied, sponsors are required to submit an expedited report to FDA within 15 days ...
  • Regulatory NewsRegulatory News

    FDA Proposes New Databases to Monitor CAR T-Cell Safety Across INDs

    The US Food and Drug Administration (FDA) wants to create two new databases that will allow it to look at safety and manufacturing information across multiple applications for products within a promising class of cancer immunotherapies called anti-CD19 CAR modified T-cells. FDA officials presented their proposal to pilot the databases last week during a meeting of the Recombinant DNA Advisory Committee (RAC), which is organized by the National Institutes of Health's (NIH...
  • Regulatory NewsRegulatory News

    Industry Seeks More Leniency in FDA Draft Guidance on Safety Assessments for INDs

    A number of drugmakers are calling on the US Food and Drug Administration (FDA) to be more flexible with sponsors in developing guidance on safety assessments for investigational new drug (IND) applications, according to comments published Wednesday on the draft document. The draft guidance from December calls on sponsors to create a safety assessment committee (SAC) to review safety information in a clinical development program and make recommendations to the sponsor ...
  • Regulatory NewsRegulatory News

    FDA Offers Draft Guidance on IND Safety Reporting

    For investigational new drug application (IND) sponsors running clinical trials and debating when a serious adverse event can be linked to an investigational drug and is serious enough to unblind data, FDA offered new draft recommendations on Wednesday. The new guidance on IND safety reporting follows previous guidance on Safety Reporting Requirements for INDs and BA/BE Studies from 2012 and contains specific details on: The composition and role of a safety assessment ...