• Regulatory NewsRegulatory News

    FDA Again Exercises Rarely-Used Emergency Approval Authority

    Citing continued risks to human health, the US Food and Drug Administration (FDA) has once again granted market access for an in vitro diagnostic device meant to detect the H7N9 influenza virus, using its emergency authority under a little-known law. Background In March 2013, FDA was given a host of new authorities and responsibilities under the  Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) , a piece of legislation meant to bolster the govern...
  • Regulatory NewsRegulatory News

    PhRMA: Recommended Language in FDA Accelerated Drug Labeling Guidance Misleading

    Pharmaceutical industry trade group PhRMA has come out forcefully against language contained within a draft guidance document issued in March 2014 by the US Food and Drug Administration (FDA), calling the agency's take on labeling drugs granted accelerated approval potentially confusing to patients and undercutting faith in the regulatory system. Background FDA's  accelerated approval pathway  is one of several tools used to expedite the approval of medicines inte...
  • Regulatory NewsRegulatory News

    FDA Finalizes Expedited Product Guidance With Hundreds of Major, Minor Changes

    The US Food and Drug Administration (FDA) has finalized its long sought-after guidance document on the use of its four expedited drug approval programs, including the recently instituted breakthrough product designation. Background FDA released the draft expedited programs guidance, Expedited Programs for Serious Conditions—Drugs and Biologics , in June 2013. In the draft, FDA outlined how it says it planned to use four tools at its disposal designed to expedite ...
  • 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...
  • FDA Launches Long-Awaited Expedited Approval Program Aimed at High-Need Devices

    The US Food and Drug Administration (FDA) has released a long-awaited draft guidance document outlining an expedited approval pathway that can be used by sponsors of medical devices intended to treat life-threatening or "irreversibly debilitating" diseases or conditions. Background: EAP Basics The guidance, which for months has been rumored to be near completion , introduces the "Expedited Access Premarket Approval" program, or EAP for short. Regulatory officials said ...
  • Legislators Call for Government Investigation Into Industry Influence on FDA Approval of Painkiller

    As pressure continues to mount on the US Food and Drug Administration (FDA) over its October 2013 decision to approve a controversial pure hydrocodone painkiller known as Zohydro ER (hydrocodone bitartrate), several legislators are trying to convince the government itself to launch an investigation into the matter. Background: What is Zohydro? FDA approved Zohydro in October 2013. The approval decision was seen by many as surprising, as it followed an FDA advisory commi...
  • FDA Releases New Accelerated Approval Labeling Guidance

    A new guidance document published by the US Food and Drug Administration (FDA) is intended to clarify how drugs approved through the accelerated approval pathway should be labeled. Background FDA's accelerated approval pathway is one of several tools used to expedite the approval of medicines intended to treat serious or unmet needs. Under Section 506(c) of the Federal Food, Drug and Cosmetic Act (FD&C Act), accelerated approval is reserved for products intende...
  • Endo's Aveed Approved by FDA, Drawing Anger from Consumer Group

    US regulatory officials today approved Endo Pharmaceuticals' testosterone replacement therapy drug Aveed (testosterone undecanoate), ignoring a petition submitted last week by a consumer group that claimed the agency should first conclude a safety review of alternative products. Background FDA recently initiated a safety review of testosterone replacement therapy drugs-more commonly known as "Low-T" drugs-after several studies raised concerns about their cardiovascular ...
  • CFDA Announces Expedited Review Process for Innovative Devices

    The China Food and Drug Administration (CFDA) announced on 7 February 2014 the implementation of a new expedited priority review and approval process for innovative medical devices, to take effect as of 1 March 2014. The CFDA stressed that the expedited procedure would not lower existing review and approval standards, but instead would expedite the marketing of new innovative medical device technologies. The new process is also expected to promote the research and dev...
  • CDRH Lays Out Plan for Accelerated Approval Pathway for Devices, Other Improvements

    The US Food and Drug Administration's (FDA) device regulatory division, the Center for Devices and Radiological Health (CDRH), has released a document outlining its strategic priorities over the next year, highlighting a focus on several topics long sought after by members of industry, including an accelerated approval pathway for some devices. The Basics The document, CDRH 2014 Strategic Priorities , sets three priorities for CDRH at its outset: strengthen the cli...
  • FDA Provides Update on Breakthrough Product Designation Program, Showing Industry Interest

    More than one year has passed since the US Food and Drug Administration (FDA) was first given the authority to give products "breakthrough" designation under the Food and Drug Administration Safety and Innovation Act (FDASIA) , granting companies a range of tools to accelerate the review of a product. But despite not having much in the way of information about the designation until June 2013, sponsors have been nothing but eager to obtain it, according to data released ...
  • In Landmark Move, First Breakthrough Product Obtains FDA Approval

    The US Food and Drug Administration (FDA) has announced its first-ever approval under the breakthrough product designation, a new approval pathway of sorts intended to expedite the process by which highly promising products reach the market. Background Under the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, FDA was given the authority to use a new expedited approval program known as breakthrough product designation. As defined by FDA, breakt...