Formal meetings between the fda and sponsors or applicants of. Briefing books are often accompanied by short memos and oral briefings that glean important findings or recommendations. A new draft guidance from fda explains how sponsors can submit a formal request for a meeting, which can be facetoface, teleconference videoconference meetings or written responses only, what sponsors should include in that request, how fda can respond, how long the agency can take to respond, and how the sponsor and fda can go about conducting efficient, consistent, timely and effective. The ind development process clinical research resource hub. Nih fda protocol template resources the regardd website is a collaboration between the regulatory affairs specialists from the north carolina ctsa institutions and is comprised of helpful tools, templates, decision trees, and educational resources to. It highlights information for state fiscal year sfy 2019, which covers the period of july 2018 through june 2019, and it provides historical data on our programs. Submit meeting package along with meeting request type b and c. The book should be approximately 20 to 30 pages long, and should be organized in a way that complements the sponsors oral presentations. Submitting a meeting request food and drug administration. Although the ib also serves other purposes, it is primarily written to enable investigators conducting clinical studies to assess the risks and benefits associated with an investigational product. An academic researcher may be required to submit an ind application to the fda in order to study a marketed medical product in a new i. Health authority briefing documents also known as briefing packs, briefing packages, and briefing books are documents prepared by a pharmaceutical company to support its interactions e.
A brief statement summarizing the purpose of the meeting. Harborside financial center, plaza v jersey city, nj 07311 ceftaroline fosamil for injection in complicated skin and skin structure infections. This is a description of what the investigational product will be i. How are briefing books used in management reporting. Upon completion of required studies or literature in support of safety and efficacy, pdg will submit a prenda meeting request, prepare a prenda briefing package and facilitate another meeting with fda. Ecommerce research project intended to attract small business owners wanting. Prepared for the 2018 kansas legislature ks leg research. A commentary published in july 8, 2009 journal of the american medical association jama underscored the importance of food and drug administration fda approval documents in conducting truly independent evaluations of the therapeutic value of new drugs. The length of the briefing book should be no more than 50 pages excluding annexes. Is an fda preind meeting worth it how to decide how to. The template should be used as a guide and judgement exercised as to which sections are relevant to the product for. The us food and drug administration fda requires a 510k for moderaterisk class ii medical view definition. The briefing book covers 10 topics, including cybersecurity, chinas expanding power, u.
In addition, there should be a short description of how the drug substance is prepared including any excipients that are added for longterm stability. The best way to write a creative brief includes templates. Make sure to finalize agreements with fda on the sap methodology early so preparation for the integrated global database, the gidb can. Proposed studiestrials to support evaluation of abuse potential. How to get the most out of your meeting the request submit request in writing clearly identify your submission as a meeting request include relevant background in the request objective expected outcome draft questions with paragraph of explanation proposed industry attendees. Clinical submission integrated statistical analysis plan. A briefing book provides a decision maker with an overview of an issue or problem, guiding policy with recommendations or with deep background and analysis. The investigators brochure ib is a multidisciplinary document that summarises the main elements of an entire development programme to date. The investigators brochure a multidisciplinary document. It also makes it easier to iterate on the project down the road. Guide to document preparation executive secretariat.
However, since fda assigns a preind number, which ultimately becomes the ind number, and module 1 includes at least two places that are appropriate for including preind documents either module 1. Or bibliographyptyp or biographyptyp or pubmed booksfilter or. Data to support discussion organized by discipline and question. The economic services administrations briefing book is a reference guide to our programs, client demographics, caseloads, and expenditures. The first such vaccine submitted to the fda was an inactivated hiv1. Kansas legislators are called upon to make decisions on many issues that come before the. Fda project managers will use established templates to ensure that all important meeting. The first thing you will need to do is be clear about what your executive summary is for. The briefing package contains background information prepared by the food and drug administration fda for the panel members of the advisory committee. Put yourself into the shoes of regulators while preparing the briefing book as resources at agencies are. The purpose of the law is to improve clarity and simplicity in government communication. Submit meeting package at least 1 month before formal meeting. As a rule, an executive summary shouldnt be more than 1.
Preparing for an fda advisory committee meeting mddi online. Guidance on the briefing book for cadth scientific advice 1 november 22, 2016 the cadth briefing book template and guidance on the briefing book are based, with permission, on those developed for the scientific advice process at the national institute for health and care excellence nice. A list of the final questions for discussion grouped by discipline and with a brief summary for each question to explain the need or context for the question. The scientific advice of the fda is organized as preind investiga tional new drug. White papers and briefing books harvard university. In addition, members of the legislature are frequently asked by constituent groups to discuss public policy issues in a community forum in their districts. For a beneficial prenda meeting, preparation is key. The importance of fda approval packages and briefing.
Eop2 meeting should be held before phase 3 trials begin, and topics include. Russia relations, north koreas nuclear weapons ambitions and tensions with iran. Health authority briefing documents also known as briefing packs, briefing packages, and briefing books are documents prepared by a pharmaceutical company to. Dockets management food and drug administration 5630 fishers lane, rm 1061 rockville, md 20852. Contact fda follow fda on facebook follow fda on twitter view fda videos on youtube subscribe to fda rss feeds fda homepage contact number 1888info fda 18884636332. Keep the book simple and clearly headline each section so that its easy to find things. Guidance on the briefing book for cadth scientific advice.
In short, the briefing document should provide summary information relevant to the product and any supplementary information needed to develop responses to potential issues raised by you as the sponsor or fda. Preparation and public availability of information given. It is the sponsors responsibility to prepare an fda briefing book. Briefing book or briefing materials voisin consulting life sciences. Fda issues new draft guidance on submitting formal meeting. As background, this briefing package includes a brief description of the history of cell substrates used for viral vaccine manufacture in the u. Writing a briefing book for a cder advisory committee. Your goal is to grab the readers interest and show them the potential in your business or project. Information on the stability program should be provided here or reference the drug manufacturers drug master. The templates will save you a great deal of time and will enable you to develop excellent briefing books provided you use them wisely. Briefing book guide a briefing book provides a decision maker with an overview of an issue or problem, normally in support of policy findings or recommendations. The hub provides information, templates and resources to guide you through the ind process.
On october, 2010, president obama signed into law the plain writing act of 2010. How fda advisory committee members prepare and what influences them. File the saps early with fda as a component of the sponsors end of phase 2 briefing document. Following is a template to help guide you as you put together your own briefing book. Briefing book ceftaroline fosamil for injection page 1 of 195 september 7, 2010 1. Stuff archive contact instructions for authors feature article template word. All written comments should be identified with this documents docket number. This gives everyone who might come into the project at any point in time a highlevel understanding of what the project is.
Build a template in clearpoint onceand after that, all it takes to generate a briefing book is the click of a button. Type a needed immediately for otherwise stalled development program type b preind, endofphase ii, prenda meetings type c any other meeting not a type a or type b. This critical document is the companys opportunity to provide the agency with all essential facts about the product. Requested fda attendees guidance for industry, formal meetings with sponsors and applicants. It needs to show them that you know what you are doing. Though the briefing document content will vary depending on the product, indication, phase of product development, and issues to be. Questions and company position format different from fda package, but idea is similar questions should be detailed and precise each question is followed by a separate companys position including justification of the companys strategy. Chmp briefing document template standard headings in the template should be used whenever possible. This guidance provides recommendations to industry on formal meetings between the food and drug administration fda and sponsors or. Guidance for industry food and drug administration. Briefing books are often accompanied by oral briefings that present the most important findings or recommendations. The table of contents can be a good place to start in working with the templates for any of the briefing books presented. Any essential selfstanding documents such as study protocols, reports, etc. Sponsor fda meetings pdufa 2 defined 3 types of meetings.
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