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  • Regulatory NewsRegulatory News

    FDA Warns California Ophthalmologist Again Over Clinical Trial Violations

    For the second time since 2000, the US Food and Drug Administration (FDA) has sent a warning letter to a Newport Beach, California-based ophthalmologist over objections to a clinical trial run by him. The latest letter, released Tuesday, claims that Dr. Thomas Tooma of the NVISION Laser Eye Centers ran a clinical trial at seven sites with an unapproved drug without first submitting an investigational new drug (IND) application to FDA as required by law. “Your investig...
  • Regulatory NewsRegulatory News

    FDA to Require Electronic Submission of New Drug, Biologic Files in Next Two Years

    Within two years, the US Food and Drug Administration (FDA) will require all new drug and biological product submissions to be sent electronically, the regulator announced this week. Background FDA has received electronic submissions from drug companies since at least 2003, when it adopted the International Conference on Harmonisation's (ICH) electronic common technical document (eCTD). The submission standard is used by many of the world's top regulatory bodies, incl...
  • Regulatory NewsRegulatory News

    23 Million Hours Spent Each Year Complying With Clinical Trial Requirements, FDA Estimates

    Conducting clinical research is difficult. Patients need to be protected, protocols adhered to, results meticulously recorded and hundreds of regulations followed. And when all is said and done, the US Food and Drug Administration (FDA) estimates that complying with its clinical trial regulations takes almost 23 million hours each year. Background FDA regulates clinical trials under Chapter 21 of the Code of Federal Regulation , Section 312 (21 CFR 312). The section ...
  • Regulatory NewsRegulatory News

    FDA Sees 92% Increase in Requests for Compassionate Access to Medicines in 2014

    Last year, the US Food and Drug Administration (FDA) received—and approved—substantially more requests for "compassionate" access to potentially life-saving treatments than any time since at least 2010, according to new data provided by the regulator. Background The data relate to FDA's "expanded access" program—sometimes called its "compassionate use" program—which was created to allow a pathway for terminally or critically ill patients to obtain access to drugs they...
  • Regulatory NewsRegulatory News

    FDA Wants Input on How to Improve Clinical Trials Process for Industry

    The US Food and Drug Administration (FDA) wants the public's feedback on ways it can make it easier to communicate with the agency during the clinical trials process. In an announcement in the Federal Register on 28 October 2014, FDA said it had established a docket at regulations.gov to allow it to receive comments from industry, the public and other organizations interested in formulating "best practices for communication between FDA and investigational new drug appl...
  • Regulatory NewsRegulatory News

    Senators Want Detailed Data on FDA's Compassionate Use Program, Including Potential Improvements

    Three Republican legislators are pressing the US Food and Drug Administration (FDA) to provide them with information about its application of its expanded access regulations, saying they are in the midst of performing "oversight" over the program. Background FDA's expanded access regulations, sometimes referred to as its "compassionate use" program, allow patients to access clinical trials they otherwise might not be eligible for. The program is meant to offer ho...
  • Regulatory Explainer: FDA Clarifies Bioequivalence, Bioavailability Approaches for Innovative Drugs

    The US Food and Drug Administration (FDA) has published a new draft guidance recommending various approaches when conducting bioequivalence (BE) and bioavailability (BA) studies in support of new and investigational drug applications. What Does FDA Mean by BA/BE? BA refers to the extent to which a drug is absorbed into the body and is thus available to act upon the drug's intended target, also known as the "site of action" (21 CFR 320.1[a]). For example, if a drug is in...
  • CBER Finalizes Two Guidance Documents on Use of Hematopoietic Progenitor Cells

    Two new guidance documents just released by the US Food and Drug Administration (FDA) finalize recommendations for Biologics License Applications (BLAs) and Investigational New Drug Applications (INDs) submitted in support of minimally manipulated placental or umbilical cord blood intended to help treat patients with hematopoietic system disorders. Hematopoeietic system disorders include ones affecting red blood cells (e.g. anemia), granulocytes (e.g. granulocytopenia), ...
  • As Supplement Industry Highlights Problems, FDA Reopens IND Guidance for Comment

    The US Food and Drug Administration (FDA) has reopened a comment period for a guidance document that aims to clarify the circumstances in which a research study involving human subjects may be conducted without first filing an investigational new drug application (IND) with the agency. Background: IND Basics The draft version of the guidance was released in September 2013, and is intended to make clear the cases when an IND is not required. In general, any investigat...
  • ExplainersExplainers
    Regulatory NewsRegulatory News

    Regulatory Explainer: FDA's Expanded Access (Compassionate Use) Program

    Regulatory Focus'  ongoing series of  Regulatory Explainers  wants to take complicated regulatory topics and make them simple for anyone to understand. In our latest Regulatory Explainer, we break down FDA's expanded access-sometimes referred to as compassionate use-regulations to understand how they work. Updated 4 February 2015. What's a Compassionate Use Program? Let's back up for a quick moment: Under current US Food and Drug Administration (FDA) regulations, ...
  • FDA Guidance Establishes When an IND May Not be Required to Conduct Human Studies

    The US Food and Drug Administration (FDA) has released a new final guidance document intended to assist sponsors in determining whether a research study involving human subjects may be conducted without first filing an investigational new drug (IND) application with US regulators. Background: The FMT Precedent In recent months, FDA has proven to be somewhat amicable to the idea of extending enforcement discretion-that is, expressing that it won't punish an entity-when h...
  • Final FDA Guidance on IRBs Illustrates Common Problems Faced in Trial Setup Phase

    The US Food and Drug Administration (FDA) has announced the publication of a new guidance document intended to guide institutional review boards (IRBs), clinical investigators and sponsors of clinical trials on whether clinical sites are compliant with regulations and whether an investigational application must be submitted to FDA. Background Clinical research is at the heart of FDA's regulatory oversight capacity. Good review decisions rely on good clinical data-r...