• RAPS' LatestRAPS' Latest

    RAPS Announces New Board Slate

    The RAPS Nominating Committee has announced its slate of one new officer and three directors nominated to serve on the RAPS board of directors for terms beginning January 2016. Current board member Susumu Nozawa, RAC, FRAPS, director, technical and regulatory policy/corporate regulatory affairs for BD, has been nominated to serve as the body’s next president-elect. The president-elect serves in that role for one year before succeeding to become president, then chai...
  • Feature ArticlesFeature Articles

    Agency Meetings with the US Food and Drug Administration

    Informational guidance meetings with representatives from the US Food and Drug Administration (FDA) have been part of the original Prescription Drug User Fee Act ( PDUFA ) and were included in the PDUFA reauthorization in 2012. 1 A second revision of the FDA guidance document for these meetings was released as a draft for comments in March 2015. This new draft guidance updates the meeting instructions and incorporates changes resulting from the Food and Drug Adminis...
  • Feature ArticlesFeature Articles

    Scientific Advice Meetings With Health Canada

    Types of Meetings With Health Canada Meetings with Health Canada are similar to US Food and Drug Administration (FDA) meetings or Scientific Advice meetings with either the European Medicines Agency (EMA) or individual EU Member States. A meeting request is submitted with questions to provide some background to introduce the agency to the company’s development program and establish why the meeting is needed. Once a meeting date has been set, the company sends a meeting p...
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    RAPS Seeks Board Nominations

    RAPS is seeking regulatory leaders to serve on its board of directors for the 2016–2018 term. Nominations and all supporting materials, including resume or curriculum vitae (CV) and two letters of support, are due to RAPS by 1 May 2015. Nominees must be full members in good standing. RAPS is looking to fill the positions of president elect and three directors. The board is the organization’s strategic governing and policy body. To submit a nomination, first revie...
  • Regulatory NewsRegulatory News

    Meeting With FDA? Here's What Regulators do (and Don't) Want from Drug Companies

    A new guidance document issued by the US Food and Drug Administration (FDA) is meant to outline the agency's expectations for meetings that take place between FDA and a sponsor before and after the submission of a new chemical or biological drug product. Background Since the passage of the original Prescription Drug User Fee Act (PDUFA) in 1992, the pharmaceutical and biopharmaceutical industries have helped to fund the operations of FDA through payments of so-called ...
  • Regulatory NewsRegulatory News

    India Proposes to Waive Phase III Trials for Drugs Approved in a 'Well-Regulated Country'

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. India’s Drugs Technical Advisory Board (DTAB) has recommended granting Phase III clinical trial waiver to some drugs approved in "well-regulated" countries like the US or EU. The waiver would also require drug sponsors to agree to implement a four-year post-marketing s...
  • Regulatory NewsRegulatory News

    Potential Medical Device Regulatory Changes Coming to India in 2015

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. India’s health ministry, the Department of Health and Family Welfare, will submit proposed changes to the country’s medical device and pharmaceutical laws to Parliament in 2015. The proposed  Drugs and Cosmetics (Amendment) Bill , 2015  would adopt definitions of medical devices as well as in vitro diagnostic (IVD) products more in...
  • Regulatory NewsRegulatory News

    EMA Scrambles to Consider Options After Leader Ousted

    Members of the European Medicines Agency (EMA) met last week to consider an unprecedented question: How should they select a new, permanent leader after they were forced to fire the last one? Background On 13 November 2014, the EU Civil Service Tribunal found that Guido Rasi, then EMA's executive director of three years, had been appointed through an improper selection process and that his appointment would be annulled. At the time, a seemingly stunned EMA said ...
  • Regulatory NewsRegulatory News

    FDA Announces a Secretive Meeting to Discuss an Unknown Drug for Unknown Reasons

    The US Food and Drug Administration (FDA) regularly convenes panels of its various Advisory Committees to offer the agency advice on a wide range of regulatory topics—everything from general policy recommendations to specific advice on a particular drug or drug class. In general, those panels—and the advice they dispense—is open to the public. For example, per 21 CFR 314.430(d) , most drug products being assessed by FDA's advisory committees are open to the public and a...
  • Regulatory NewsRegulatory News

    Are New Policies Needed to Help Regulate Generic Drugs? FDA Wants to Know

    US drug regulators are getting ready to take a close look at the regulation of generic drugs, including new policies recently proposed by the US Food and Drug Administration (FDA) and areas that could stand to benefit from additional regulation. Background In a new Federal Register notice posted on 18 August 2014, FDA said it will soon hold a meeting to focus on the implementation of the Generic Drug User Fee Act (GDUFA), a program passed as part of the 2012 Food and...
  • Regulatory NewsRegulatory News

    Following Criticism, FDA to Focus on Female Sexual Disorders at Upcoming Patient Meeting

    The US Food and Drug Administration (FDA) this week quietly announced that it soon plans to hold a meeting on female sexual dysfunction (FSD) as part of a larger effort to bring patients into the drug development process to fine-tune its benefit-risk assessment process. Background The meeting will be the 11th under FDA's Patient-Focused Drug Development process—an initiative created under the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) to he...
  • Regulatory NewsRegulatory News

    Health Canada, SwissMedic Join ICH as Steering Committee Members

    The International Conference on Harmonization (ICH), the influential international pharmaceutical regulatory harmonization body, has elected to add two new regulators to its Steering Committee, the group has announced. In an announcement on 8 July 2014, ICH said Health Canada (HC) and Swiss regulator SwissMedic would both be joining its Steering Committee "in recognition of their historical involvement and commitment to ICH." The Steering Committee, which previously onl...