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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    The draft guidance on the special protocol assessment (SPA) process is an update on guidance from 2002 and delves into the meetings between pharmaceutical or biotech sponsors and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    New Draft Guidance on Best Practices for IND Communications Between Sponsors, FDA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drug development phases now will have a new set of best practices to consult with prior to their meetings thanks to draft guidance released by FDA on Friday.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...
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    Preparing for an FDA Advisory Committee Approval Meeting

    This article discusses the nuances of FDA Advisory Committee approval meetings and provides an interpretive overview of what regulatory professionals need to know to prepare for a meeting. Introduction The US Food and Drug Administration (FDA) define an Advisory Committee simply as a group of external experts convened to offer advice to the agency. However, in realty, the practice is more complicated. In other places on its website, FDA states Advisory Committees can ...
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    FDA to Host Public Meeting on Psoriasis Patient Perspectives

    The 17 March 2016 public meeting at the US Food and Drug Administration (FDA) will allow for patients to offer their unique perspectives on the impact of psoriasis, including on daily life and treatment options. FDA says it’s interested in “patients’ perspectives for the types of psoriasis with primarily skin symptoms (such plaque psoriasis, nail psoriasis, guttate psoriasis, etc.), patient views on treatment approaches, and decision factors taken into account when selec...
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    PDUFA VI Reauthorization: Industry, FDA Discuss Broader Use of Real World Evidence

    Representatives from industry groups BIO and PhRMA met with officials from the US Food and Drug Administration (FDA) twice last month to discuss new plans for using real world evidence to support benefit-risk assessments for medical products, according to the meeting minutes of a subgroup of the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA). Background Congress created the Prescription Drug User Fee Act (PDUFA) in 1992 to help FDA collect fees from...
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    FDA Finalizes Guidance on Formal Meetings with Biosimilar Sponsors

    The US Food and Drug Administration (FDA) on Wednesday plans to release finalized guidance on formal meetings between FDA and biosimilar sponsors. The agency said that as a result of the public comments on the draft guidance from April 2013, information has been added “to provide clarity on the process for requesting meetings, including identifying the appropriate meeting type and the data expectations to support the appropriate meeting type.” The Generic Pharmaceut...
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    Do Public Hearing Participants Influence Outcomes of FDA Advisory Committee Meetings?

    This article discusses the importance of the open public hearing portion of an FDA Advisory Committee meeting. Many regulatory changes have impacted the US Food and Drug Administration (FDA) approval process for new drugs and medical devices, including the requirement from the Food and Drug Administration Amendments Act for an Advisory Committee review. Advisory Committees provide the agency with advice from outside experts on issues related to drugs, biological prod...
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    PMDA Consultation in Japan

    This article focuses on PMDA consultations for drug development. Japan's Pharmaceuticals and Medical Devices Agency (PMDA) was established by the Ministry of Health, Labour, and Welfare (MHLW) in 2004. In addition to scientific reviews and conformity audits of marketing authorization applications for drugs and medical devices, PMDA provides various types of consultations, from pharmaceutical affairs on research and development strategy to clinical trials. It is valuabl...
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    FDA Approving Most New Drugs and Biologics During Their First Review, Report Finds

    The US Food and Drug Administration's (FDA) is now approving more new drugs and biologics during their first review cycles than at any time since at least 2008, a new FDA-commissioned report shows. Background The report , conducted by the Eastern Research Group (ERG) on behalf of FDA, is focused on the fifth iteration of the Prescription Drug User Fee Act (PDUFA) , which was passed in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA) . P...
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    Breaking Down Barriers to Drug Innovation a Team Effort, FDA Says in Guidance

    A new guidance document just finalized by the US Food and Drug Administration (FDA) aims to clarify how pharmaceutical companies and the public can help accelerate drug development through the agency's Critical Path Initiative (CPI). Background FDA's Critical Path Initiative was created in March 2004 as an attempt to identify and dismantle unnecessary roadblocks to new product innovation and regulatory approval. These roadblocks, which would exist on a product's "critic...