• Regulatory NewsRegulatory News

    FDA, Absent From Hearing, Makes the Case That it's Increasingly Innovative

    Yesterday, US legislators in the House Energy and Commerce Committee held a hearing to discuss how the federal environment—including the US Food and Drug Administration's (FDA) regulations—might be improved to bolster drug innovation. But while the pharmaceutical industry, device industry and patient groups found themselves well represented at the meeting, one prominent stakeholder found itself conspicuously excluded from the meeting: The US Food and Drug Administration. ...
  • Fitch Report Says NME Approvals Plummet at FDA in Q1, but FDA Data Paint Alternate Picture

    When trying to gauge the success of both the US pharmaceutical sector and the US Food and Drug Administration (FDA), one metric usually reigns supreme: approvals. But despite progress by the latter in shoring up its flagging approval numbers in recent years, a new report indicates the first quarter of 2014 was the worst quarter for approvals in almost 15 years. Background FDA approvals over the last decade have experienced their ups and downs. Consider the following ch...
  • FDA Blows Away Rivals in Approving Cancer Therapies

    The public persona of the US Food and Drug Administration (FDA) can ordinarily be described in a word: reserved. Its press releases frequently reveal an agency which hedges its statements, avoids hyperbole, and mostly steers clear of speculation. But every now and again, it feels like bragging a bit. Regulatory Braggadocio Specifically, it feels like bragging about how it compares to its foreign regulatory counterparts like the European Medicines Agency (EMA). While th...
  • Report Finds Huge Variations in CDER Performance, but Few Explanations as to Why

    New research published by the Manhattan Institute for Policy Research (MIPR), a right-leaning think tank which focuses in part on pharmaceutical regulation policy, indicates that there are wide gaps in performance among the US Food and Drug Administration's (FDA) review divisions, resulting in a "productivity gap" that has left some patients without ready access to new therapies. Background MIPR's research report, An FDA Report Card: Wide Performance Found Among Agenc...
  • EMA, TGA Launch New 'Collaboration' to Accelerate Access for Orphan Medicines

    EU and Australian regulators have announced that they will begin sharing information about orphan medicines in an attempt to accelerate approval for new drugs intended for rare diseases. Background Orphan medicines are those intended for diseases or conditions which affect a small number of individuals-so-called "rare diseases"-and are thus less likely to have a ready market to incentivize investment in new therapies. The definition of "rare disease" differs throughout...
  • FDA, ONC Issue Long-Awaited Health IT Framework

    The US Food and Drug Administration (FDA) has released for consultation a new proposed framework on how to regulate health information technology (IT), including mobile medical device applications ("apps") according to risk. Background Mobile medical applications can best be understood as programs run on a mobile device such as a smartphone or tablet that allow a user to access a medical technology wherever and whenever they wish. For example, a smartphone application t...
  • In Major Victory for Industry, FDA says Existing 510(k) Guidance to Remain 'Mostly Unchanged'

    The US Food and Drug Administration (FDA) has released the text of a congressionally mandated report outlining its plans for the future of its medical device premarket notification process-also known as the 510(k) clearance process-saying that it intends to largely leave its existing 1997 guidance document as-is. Background In 2011, FDA released a new guidance document,  510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Devic...
  • GAO Says FDA Doing (Almost) All It Can to Alleviate Drug Shortages

    The US Government Accountability Office (GAO) has released a follow-up report on the national problem of drug shortages, lauding the US Food and Drug Administration (FDA) for making efforts to alleviate drug shortages. Background "The number of drug shortages remains high," begins the report, released on 10 February 2014. While GAO noted significant progress in confronting new drug shortages in 2013 compared to 2012, its data portrayed the stubbornness with which some o...
  • FDA to Generic Drug Industry: User Fee Program Leading to Significant Improvements

    Perhaps no industry regulated by the US Food and Drug Administration (FDA) is undergoing as big a change in the way it is regulated right now as the generic drug industry. Background Under the terms of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, the generic drug industry must now contribute to FDA's operational budget through user fees. Those fees are paid every time a company submits an abbreviated new drug application, a drug master...
  • Technology Blueprints for PDUFA, GDUFA Programs Released for Comment

    US regulators last week released the texts of two reports, mandated under the terms of the most recent user fee agreements, detailing two five-year plans to improve the information technology services of the agency's novel and generic drug departments. Background Both reports, required under the Food and Drug Administration Safety and Innovation Act (FDASIA) , are essentially blueprints for how FDA can improve its technological capacities in order to make its regulator...
  • Independent Report Says FDA's Medical Device Review Process in Need of Improvement

    The US Food and Drug Administration (FDA) has released the text of an outside assessment of how it reviews medical device submissions, saying it plans to quickly act on several "high priority" recommendations to improve its regulatory processes. Background The medical device industry has often lambasted FDA's review process as being increasingly onerous, slow and unpredictable -a view also shared by government investigators. Though officials within the Center for Dev...
  • European Commission Committee Clears PIP Breast Implants of Major Health Concerns

    The European Commission has released the text of a long-awaited follow-up opinion regarding the safety of breast implants manufactured by the now-defunct Poly Implant Prothese (PIP), a French manufacturer whose products ignited a firestorm of controversy over the safety of medical devices in the EU after they were found to have been manufactured to deficient standards. Background The PIP scandal erupted in late 2011, when regulators determined that the company had bee...