• Regulatory NewsRegulatory News

    Medical Device Data Systems to be Exempt from Regulation, FDA Says

    In a stark reversal, US Food and Drug Administration (FDA) regulators today said they would exempt medical device data systems (MDDS)—systems used to collect and store data from other medical devices like weight scales and glucose meters—from regulation, abandoning an earlier plan to regulate them as Class I ("low-risk") medical devices. The announcement comes more than three years after FDA down-classified MDDS devices from Class III ("high-risk") to Class I. Whil...
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    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    The US Food and Drug Administration (FDA) has published a new draft guidance recommending various approaches when conducting bioequivalence (BE) and bioavailability (BA) studies in support of new and investigational drug applications.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...
  • 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...
  • 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...
  • Do They 'Like' Us? FDA Wants Tool to Better Assess its Impact on Social Media

    The US Food and Drug Administration (FDA) doesn't always seem like it's listening to its stakeholders. But if a recent sources-sought notice posted to the Federal Business Opportunities (FBO) website is any indication, it's listening a lot more closely than most people would realize. A hallmark of many businesses in the last few years has been the use of analytics tools to gauge the impact of various "campaigns," including on social media. For example, by using special p...
  • FDA Preparing to Devote more Resources to Social, Mobile Outreach

    The US Food and Drug Administration (FDA) is, first and foremost, a public health agency responsible for regulating the safety and efficacy of healthcare products. But central to that mission is how it communicates with the public about those products, something made even more complicated with the advent of new technologies. Background These difficulties are put on display in a new report just published by FDA, which notes that the last two decades have seen the develop...
  • Safety Main Challenge to Preparing INDs for Cellular and Gene Therapy Products, Says FDA

    The US Food and Drug Administration (FDA) has released a new draft guidance document intended to outline the considerations industry should take into account when designing early-phase clinical trials for cellular therapy (CT) and gene therapy (GT) products. Background The draft guidance, released on 2 July 2013 by FDA's Center for Biologics Evaluation and Research (CBER), is specifically targeted at investigational new drug applications (INDs), which are used by compan...