White papers and briefing books harvard university. Submit meeting package along with meeting request type b and c. The purpose of the law is to improve clarity and simplicity in government communication. Stuff archive contact instructions for authors feature article template word. Proposed studiestrials to support evaluation of abuse potential. Is an fda preind meeting worth it how to decide how to. The best way to write a creative brief includes templates. The table of contents can be a good place to start in working with the templates for any of the briefing books presented. Though the briefing document content will vary depending on the product, indication, phase of product development, and issues to be. Submit meeting package at least 1 month before formal meeting. Guidance for industry food and drug administration. Guidance on the briefing book for cadth scientific advice. This is a description of what the investigational product will be i. Guide to document preparation executive secretariat.
For a beneficial prenda meeting, preparation is key. Prepared for the 2018 kansas legislature ks leg research. Formal meetings between the fda and sponsors or applicants of. 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. 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. It is the sponsors responsibility to prepare an fda briefing book. This guidance provides recommendations to industry on formal meetings between the food and drug administration fda and sponsors or. Make sure to finalize agreements with fda on the sap methodology early so preparation for the integrated global database, the gidb can.
Fda project managers will use established templates to ensure that all important meeting. 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. 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. How are briefing books used in management reporting. Put yourself into the shoes of regulators while preparing the briefing book as resources at agencies are. Russia relations, north koreas nuclear weapons ambitions and tensions with iran.
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 first such vaccine submitted to the fda was an inactivated hiv1. Submitting a meeting request food and drug administration. 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. Sponsor fda meetings pdufa 2 defined 3 types of meetings. This critical document is the companys opportunity to provide the agency with all essential facts about the product. Briefing books are often accompanied by oral briefings that present the most important findings or recommendations. Briefing books are often accompanied by short memos and oral briefings that glean important findings or recommendations.
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. Writing a briefing book for a cder advisory committee. The hub provides information, templates and resources to guide you through the ind process. Or bibliographyptyp or biographyptyp or pubmed booksfilter or. The scientific advice of the fda is organized as preind investiga tional new drug.
Briefing book ceftaroline fosamil for injection page 1 of 195 september 7, 2010 1. Fda issues new draft guidance on submitting formal meeting. The length of the briefing book should be no more than 50 pages excluding annexes. 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 ind development process clinical research resource hub. It also makes it easier to iterate on the project down the road. How fda advisory committee members prepare and what influences them. Any essential selfstanding documents such as study protocols, reports, etc. In addition, members of the legislature are frequently asked by constituent groups to discuss public policy issues in a community forum in their districts. The template should be used as a guide and judgement exercised as to which sections are relevant to the product for. File the saps early with fda as a component of the sponsors end of phase 2 briefing document.
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. All written comments should be identified with this documents docket number. The investigators brochure a multidisciplinary document. 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. Briefing book or briefing materials voisin consulting life sciences. Ecommerce research project intended to attract small business owners wanting. Formal meetings between the fda and sponsors or applicants. Build a template in clearpoint onceand after that, all it takes to generate a briefing book is the click of a button.
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. The us food and drug administration fda requires a 510k for moderaterisk class ii medical view definition. Preparing for an fda advisory committee meeting mddi online. 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. Following is a template to help guide you as you put together your own briefing book. Clinical submission integrated statistical analysis plan. You should inform your regulatory project manager if the list of attendees changes. On october, 2010, president obama signed into law the plain writing act of 2010. 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. In addition, there should be a short description of how the drug substance is prepared including any excipients that are added for longterm stability. Your goal is to grab the readers interest and show them the potential in your business or project. 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. Preparation and public availability of information given.
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. It needs to show them that you know what you are doing. 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 book should be approximately 20 to 30 pages long, and should be organized in a way that complements the sponsors oral presentations. Requested fda attendees guidance for industry, formal meetings with sponsors and applicants. The templates will save you a great deal of time and will enable you to develop excellent briefing books provided you use them wisely. 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. Information on the stability program should be provided here or reference the drug manufacturers drug master. Evaluate the phase 3 plan and protocols for adequacy and to assess pediatric safety and effectiveness. Eop2 meeting should be held before phase 3 trials begin, and topics include. The investigators brochure ib is a multidisciplinary document that summarises the main elements of an entire development programme to date.
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. 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. The briefing book covers 10 topics, including cybersecurity, chinas expanding power, u. The first thing you will need to do is be clear about what your executive summary is for. The decision maker then refers to the extended briefing book for the. Kansas legislators are called upon to make decisions on many issues that come before the.
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