• Regulatory NewsRegulatory News

    As Frozen Poop Pills Shown to be Effective in Study, FDA Policy in the Spotlight

    The US Food and Drug Administration (FDA) has a frozen poop problem, and it's getting messier with time. Background As Focus has explained in the past, FDA has been grappling with how to regulate an emerging medical procedure known as fecal microbiota transplantation (FMT) for several years. The procedure involves the transplantation of select fecal matter from one patient into another. While it may sound unusual, if not unsettling, emerging data show the procedure ...
  • 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...
  • Regulatory NewsRegulatory News

    FDA Launches New 'Trusted Trader' Import Program With Long List of Incentives

    The US Customs and Border Protection (CBP) and US Food and Drug Administration (FDA) have announced the launch of a new "Trusted Trader" program meant to expedite the import of products made by companies that meet a rigorous selection process. Background FDA and CBP have long sought to make improvements to the process used to import of products, and particularly pharmaceuticals. As explained in numerous Federal Register announcements over the years, the problem ...
  • FDA Looks to Surge Approach to Complete DESI Reviews

    In the US, as many as several thousand drugs are currently marketed without ever having received approval from the US Food and Drug Administration (FDA) as being effective for their intended purpose. While many of these drugs are simply illegal, there are others that remain on the market legally despite never having received approval. The History of Pharmaceutical Law in the US To understand why is to understand the evolving history of federal pharmaceutical law in t...
  • FDA Looks to Close Loophole That Could Delay Approval of Biosimilars

    US regulators on Monday indicated that they are moving to close a regulatory loophole identified by legislators in 2012 that could prevent a biosimilar product from obtaining timely approval. Background: FDAAA In 2007, legislators passed into law the Food and Drug Administration Amendments Act (FDAAA) , which contained a provision-Title IX, Section 914-that allows the US Food and Drug Administration (FDA) to disregard certain Citizen Petitions if their sole intent is...
  • Regulators, Industry Prepare to Dig into Liver Toxicity Concerns in Bid to Improve Safety

    A meeting proposed by US regulators would again seek to bring together the US Food and Drug Administration (FDA), pharmaceutical trade industry group PhRMA, the regulatory science-focused Critical Path Institute and public stakeholders to discuss best practices for detecting and assessing the likelihood that pharmaceutical products cause liver damage in patients. Background Liver toxicity, sometimes referred to as hepatotoxicity, is a serious but relatively c...
  • FDA Issues Revised Draft Guidance on Hepatitis C Drug Development

    The US federal government may have been shut down, but that didn't stop the US Food and Drug Administration (FDA) from releasing a new guidance document on 16 October 2013 detailing its preferred methods of developing applications in support of drugs to treat chronic infections caused by the hepatitis C virus. Background FDA has been rather active in the hepatitis C drug development space in recent years. In 2009, it issued a final guidance document, Guidance on Anti...
  • Legislators Say Acquisition of US Pork Supplier Would Imperil Safety, Availability of Heparin

    House legislators are bringing new and critical attention to a proposed purchase of Virginia-based Smithfield foods, the world's largest pork processor, by Chinese company Shuanghui International, citing a past healthcare product regulation scandal that left dozens dead and few questions answered. Background In 2007 and 2008, regulators were left scrambling as dozens US citizens died after consuming products contaminated with adulterated heparin, a substance derived fro...
  • C-Path Obtains EMA, FDA Approval for Tool to Expedite Development of Alzheimer's Treatments

    The Critical Path Institute (C-Path), a public-private hybrid organization supported directly by the US Food and Drug Administration (FDA), has announced a "big step forward for Alzheimer's disease therapy development," saying that it has obtained the support of FDA and the European Medicines Agency (EMA) to launch a new disease simulation tool intended to improve clinical trial design for investigating Alzheimer's treatments. C-Path, which was founded in 2005 under FDA'...
  • Feature ArticlesFeature Articles

    Fecal Transplant—a Very Unusual Treatment Method

    Could anyone imagine a medical condition that would warrant administering a stool specimen from a donor? Such treatment would seemingly belie the "Above all, do no harm" axiom thought to be part of the Hippocratic oath. 1 It just so happens that such treatment first occurred more than 50 years ago, and continues today. In 1958, doctors in Denver, Colorado, administered donor feces by enema to patients with fulminant, life-threatening pseudomembranous enterocolitis, an ac...
  • False Statements on Facebook Regarding FDA-Regulated Product Lead to Jail Time for Iowa Man

    Rarely does one person influence how the US Food and Drug Administration (FDA) looks at a company, but every so often one person comes along and-for better or worse-changes the agency's perspective. This article is about the latter of those two possibilities. Background An example of the former may well be Dinesh Thakur, who blew the whistle on deficient practices at Ranbaxy, practices for which the company has now paid hundreds of millions of dollars. But if that's ...
  • US Legislators Target Number of Regulatory Programs in 2013 Workflow

    The US House of Representatives' Energy and Commerce Committee, the legislative body charged with overseeing the US Food and Drug Administration (FDA), has released its planned workflow for the year, including a number of programs likely to affect regulatory professionals. Core Regulatory Programs The committee is broadly involved with healthcare, and was instrumental in passing the 2012 FDA Safety and Innovation Act (FDASIA) , which reauthorized and created a number...