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  • Regulatory NewsRegulatory News

    Formal Meetings Between FDA and Biopharma Companies: New Draft Guidance

    Know the difference between a Type A, Type B and Type C meeting with the US Food and Drug Administration (FDA)? New draft guidance released last week will help biopharma companies understand how to conduct such meetings and what to expect. The 20-page draft explains how sponsors can submit a formal request for a meeting, which can be face-to-face, teleconference/videoconference meetings or written responses only, what sponsors should include in that request, how F...
  • Regulatory NewsRegulatory News

    Biomarker Qualification: FDA Explains Process and Opportunities for Engagement

    In a set of newly released presentations, officials from the US Food and Drug Administration (FDA) explain changes to the agency's biomarker qualification program and detail early opportunities for biomarker developers to engage with FDA. "A qualified biomarker can be used in multiple drug development programs without the need for [the Center for Drug Evaluation and Research] CDER to reconfirm the suitability of the biomarker's qualified context of use," said Marianne No...
  • Regulatory NewsRegulatory News

    Trump Administration Officials Huddle at White House to Discuss Drug Pricing

    A White House spokesman confirmed to Focus that a meeting took place at the White House on Friday "as part of the ongoing discussions to reduce the burden of the high cost of drug prescriptions and unleash a wave of innovation to develop cures and treatments for patients." The confirmation follows reports from several media outlets citing sources who say the meeting, with US Food and Drug Administration Commissioner Scott Gottlieb among other officials in atten...
  • Regulatory NewsRegulatory News

    EMA Explains How it Supports Article 58 Applications

    The European Medicines Agency (EMA) on Tuesday released a document discussing the regulatory support available to drugmakers looking to submit applications via the Article 58 procedure in an attempt to increase access to medicines in low- and middle-income countries (LMICs). Background First introduced in Regulation (EC) No. 726/2004 in 2004, the Article 58 procedure allows EMA's Committee for Medicinal Products for Human Use (CHMP) to give opinions, in collaboration ...
  • Trump to Pharma CEOs: 75% to 80% of FDA Regulations Will be Eliminated

    In a sign of what’s to come for the US Food and Drug Administration (FDA), President Donald Trump told pharmaceutical company CEOs Tuesday that his administration will be “cutting regulations at a level no one has ever seen before.” The comments, which came before the meeting with CEOs from industry group PhRMA, Merck, Novartis, Johnson & Johnson, Celgene and others, Trump said in terms of the drug approval process: “We’re also going to be streamlining the process, so t...
  • Regulatory NewsRegulatory News

    BsUFA II: What’s Coming for Biosimilar Sponsors from FY 2018 Through FY 2022

    A host of biosimilar experts, industry representatives and US Food and Drug Administration (FDA) officials convened on Thursday to discuss the second iteration of the Biosimilar User Fee Act (BsUFA II) and iron out the specifics of how the program needs to adapt over the next five years as the number of biosimilar applications continues to increase. FDA Commissioner Robert Califf opened the public hearing with comments on how the agency is still trying to find the righ...
  • 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...
  • 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

    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...