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  • Regulatory NewsRegulatory News

    What's Coming in 2018: FDA's Regulatory Agenda

    The US Food and Drug Administration (FDA) published its fall 2017 agenda of proposed and final rulemakings this week, with several expected on drug compounding, allowing foreign clinical data to bring medical devices to market and new ways to market nonprescription drugs. On the compounding front, FDA plans to issue a proposed rule in August 2018 that would set minimum current good manufacturing practice requirements for human drug products compounded by an outso...
  • Regulatory NewsRegulatory News

    CDER Guidance in 2017: Lots of Procedural and Quality Documents Coming

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Wednesday released its agenda of new and revised draft guidance documents to be published this calendar year, and it includes several eagerly-awaited documents, such as ones on biosimilar interchangeability (which has been on the list since 2015) and a revision of a draft on postmarket safety reporting for drugs and biologics. The 102 draft guidance documents slated for release ...
  • Regulatory NewsRegulatory News

    FDA Plans New Regulation on Fixed-Dose Combinations, Co-Packaged Drugs

    • 22 May 2015
    The US Food and Drug Administration (FDA) plans to release two new regulations by the end of 2015, it announced this week. The announcement, contained in the latest edition of the US Unified Agenda , contains 33 proposed and final rules FDA says it hopes to publish by the end of calendar year 2015. In practice, however, some rules have remained on FDA's Unified Agenda for years. FDA's latest update of the Unified contains two additional regulations compared to its las...
  • Regulatory NewsRegulatory News

    FDA Says Nonproprietary Biologics Naming Policy Coming Later This Year

    • 29 April 2015
    The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) plans to release five additional guidance documents by the end of 2015, including one on the nonproprietary names given to biological products, it announced Tuesday. Background The 28 April 2015 announcement came in the form of an updated list of guidance documents, known as CDER's "Guidance Agenda." The list is an accounting of all guidance documents the agency plans to release—e...
  • Regulatory NewsRegulatory News

    Medical Device Group Mirrors Congress in Efforts to Improve FDA Regulation

    The US's largest medical device trade group, AdvaMed, has unveiled a new "Innovation Agenda" it hopes will complement legislative efforts meant to improve the way in which the US Food and Drug Administration (FDA) regulates medical devices. Background The agenda, released on 10 February 2015, is part of a larger push to "renew [the] medical technology innovation ecosystem," AdvaMed explained in a press statement. The ultimate goal of the initiative is to "help speed pat...
  • Regulatory NewsRegulatory News

    FDA's Veterinary Regulators Eye Dozens of Policy Changes in 2015

    The US Food and Drug Administration's (FDA) veterinary regulatory division, the Center for Veterinary Medicine (CVM), plans to release 31 new or updated policies in 2015, it has confirmed. In a notice posted on FDA's website last week , CVM announced top-level details about which guidance documents it plans to release in the coming year. Guidance documents are non-binding expressions of policy, and indicate how FDA wants members of the life science industry to comply wi...
  • Regulatory NewsRegulatory News

    FDA's CBER Announces Plans to Release Guidances on Gay Blood Ban, Ebola and More

    The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) plans to release nearly a dozen guidance documents this year, including a massively anticipated document outlining planned changes to its "donor deferral policy" that now prevents most homosexual men from donating blood. FDA's guidance documents are its interpretations of regulations and legislation, which serve to "guide" persons or companies to a state of compliance. While t...
  • Regulatory NewsRegulatory News

    FDA Plans to Release 28 Device Guidance Docs in 2015, Including on Software and Diagnostics

    The US Food and Drug Administration has just released a list of all medical device guidance documents it plans to release in 2015, including ones related to speeding up device submissions, regulating lab-developed tests (LDTs) and the regulation of decision support software. Background The list, sometimes referred to as a "Guidance Agenda," is published on an annual basis by FDA's Center for Devices and Radiological Health, its medical device regulatory division. The ...
  • Regulatory NewsRegulatory News

    CDER Plans 90 Guidance Documents in 2015, Including on Biosimilarity and Social Media

    The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has released a new list of 90 guidance documents it plans to publish in 2015, including several long anticipated and eagerly awaited by members of the pharmaceutical industry. The list, Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2015 , is published annually by FDA ( 2012 , 2013 , 2014 ), and is meant to outline FDA's regulat...
  • Regulatory NewsRegulatory News

    FDA Planning Six New Drug, Device Regulations for 2015

    The US Food and Drug Administration (FDA) has released a list of regulations it plans to release in 2015, including six new rules set to affect pharmaceutical and medical device development. Background The list, known as FDA's "Unified Agenda," is published bi-annually as required by the Regulatory Flexibility Act of 1980 and Executive Order 12866. While the list is intended to serve as an overview of the agency's planned actions for a given year, in practice just a s...
  • Regulatory NewsRegulatory News

    Six New FDA Regulations to be Introduced in 2014, Including Major Change in IND Reporting

    The US Food and Drug Administration (FDA) has released an updated list of regulations it is planning to seek in 2014, known as its "Unified Agenda," outlining six new rules it says it intends to propose in 2014. DQSA-Related Rules Several are related to FDA's new authority under the Drug Quality and Security Act (DQSA) of 2013, which contains numerous provisions intended to enhance FDA's ability to regulate compounding pharmacies. For example, FDA plans to issue pro...
  • FDA's Veterinary Division Plans to Release Dozens of Regulatory Guidances in 2014

    US veterinary product regulators from the Center for Veterinary Medicine (CVM) have released the first of the US Food and Drug Administration's (FDA) guidance agendas for the year, highlighting a range of policy initiatives they aim to undertake in the coming months. FDA, CVM's parent organization, is in the practice of releasing so-called "guidance agendas" at the beginning of each year, and sometimes updating it several times throughout the year. The intent is to allow...