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    FDA Advisory Committee Calendar

    Regulatory Focus is pleased to team with Tarius , a regulatory information services provider, to routinely offer information about upcoming FDA Scientific Advisory Committee (SAC) meetings for CDER, CBER, and the Office of the Commissioner. Upcoming Meetings   13 September – Allergenic Products Advisory Committee   The committee will discuss and make recommendations on the safety and efficacy of Peanut [Arachis hypogaea] Allergen Powder manufactured by Ai...
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    13 Keys to a Successful FDA Advisory Committee Meeting

    When the US Food and Drug Administration (FDA) has significant questions or concerns about clinical data submitted in support of a product under review, it often seeks input from independent academicians and clinicians outside the agency. For this reason, FDA has established Advisory Committees comprised of such experts in various therapeutic areas. Currently, there are 49 such standing committees. If your company is a sponsor of a product subject to Advisory Committee rev...
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    Formal Meetings Between FDA and Biopharma Companies: New Draft Guidance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 New draft guidance released last week will help biopharma companies understand how to conduct such meetings and what to expect.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...
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    Formal Meetings Between FDA and ANDA Applicants: Stakeholders Weigh Draft Guidance

    Drugmakers Sanofi and Teva, alongside industry groups AAM and the Bulk Pharmaceuticals Task Force, offered their comments earlier this month on new draft guidance related to formal meetings between FDA and abbreviated new drug application (ANDA) sponsors. The Society of Chemical Manufacturers and Affiliates’ (SOCMA) Bulk Pharmaceuticals Task Force expressed disappointment that, although it participated in the Generic Drug User Fee Amendments (GDUFA II) negotiation...
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    FDA Launches New Online Portal for Requesting Pre-ANDA Meetings

    Thanks to the new Generic Drug User Fee Act (GDUFA II), the US Food and Drug Administration (FDA) this week launched a new online platform to allow industry to request pre-ANDA (abbreviated new drug application) meetings for complex generic drugs.  The CDER Direct NextGen Collaboration Portal allows potential ANDA applicants to initiate requests by uploading a meeting request package and to submit supporting documents, such as meeting presentation materials, re...
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    EMA Explains Early Industry Engagements Following EU Ombudsman's Questions on Bias

    Following an inquiry into the perception of bias in early interactions between the biopharma industry and the European Medicines Agency (EMA), EMA executive director Guido Rasi tried to assure the EU ombudsman that the risk of bias is manageable. "While we acknowledge the need to avoid and manage any risk of bias, experience over the years shows that such risk can be managed by having in place the necessary safeguards and I can assure you that the Agency guarantees...
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    Procedures for Device Advisory Committee Meetings: FDA Finalizes Guidance

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday finalized guidance from 2015 on advisory committee meetings. Background Other than the Medical Devices Dispute Resolution Panel (which this guidance does not address), there are 17 device panels: (1) Anesthesiology and Respiratory Therapy Devices; (2) Circulatory System Devices; (3) Clinical Chemistry and Clinical Toxicology Devices; (4) Dental Products; (5) E...
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    FDA to Discuss Autism and Available Treatments in May

    An upcoming public meeting is intended to allow the US Food and Drug Administration (FDA) to obtain patient perspectives on the impact of autism on daily life, as well as views on treatment approaches. Background As part of commitments tied to the fifth reauthorization of the Prescription Drug User Fee Act (PDUFA V), under Title I of the Food and Drug Administration Safety and Innovation Act , FDA has selected autism as the focus of a public meeting on 4 May 2017, fr...
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    FDA Revises Guidance on Special Protocol Assessments

    The draft guidance on the special protocol assessment (SPA) process is an update on guidance from 2002 and delves into the meetings between pharmaceutical or biotech sponsors and the US Food and Drug Administration (FDA) to discuss plans for clinical trials. Under the hopes that the SPA process will improve the quality of clinical trials, FDA has made significant changes from 2002 guidance, including: Clarification on which protocols are eligible for SPA; The addit...
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    Strategic Regulatory Considerations for Early Medical Device Consultations with Global Regulatory Authorities

    This article discusses the early consultation process for medical devices in the EU and US and key considerations when planning such a meeting. Developing a Global Strategy for Early Consultations Are you developing an innovative medical device? Does it employ a novel technology? Does it provide novel diagnostic information or therapeutic benefit? Is it a combination or borderline product or a companion diagnostic? Do your plans to demonstrate safety, performance and/...
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    Post-Marketing Plans: An Often Overlooked Component of FDA Advisory Committee Meeting Discussions

    The article analyzes the proportion of FDA Advisory Committees specifically asked to discuss or vote on issues related to post-approval safety activities. Introduction Preparing effectively for a US Food and Drug Administration (FDA) Advisory Committee meeting requires the sponsor team's anticipation of discussion and voting topics FDA will pose to the advisory panel. Discussion topics and voting questions will influence information the team provides to the panel as w...
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    New Draft Guidance on Best Practices for IND Communications Between Sponsors, FDA

    Investigational new drug application (IND) sponsors communicating with the US Food and Drug Administration (FDA) during the various drug development phases now will have a new set of best practices to consult with prior to their meetings thanks to draft guidance released by FDA on Friday. The communications between FDA and industry are often opportunities to share cirtical information on clinical trials and for the agency to provide advice on trial design, dose selection...