Information package briefing document clear story and rationale for positions final questions supporting information 3. Regardd regulatory guidance for academic research of. The first such vaccine submitted to the fda was an inactivated hiv1. Fda briefing book 2009 otc combination medicines with acetaminophen. Briefing books can be used to disseminate your organizations performance data to more people. Finally, the paper provides examples of frequently asked questions faq and responses by the fda along with. Or you can post the report on your intranet for internal download. The decision maker then refers to the extended briefing book for the. Is an fda preind meeting worth it how to decide how to. The definitive guide to responding to fda 483 observations. 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.
Briefing book or briefing materials voisin consulting life sciences. How are briefing books used in management reporting. 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. Standard headings in the template should be used whenever possible. Government publication apa citation style, 7th edition. Though the briefing document content will vary depending on the product, indication, phase of product development, and issues to be. October 12, 2017 fda advisory committee meeting page 1 of 149 fda advisory committee briefing document spark therapeutics, inc. It is the sponsors responsibility to prepare an fda briefing book.
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 on. Use the provided template to submit a briefing book bb to nice scientific advice sa in microsoft word format. The first such vaccine submitted to the fda was an inactivated hiv1 produced in the tcell line hut78, which was derived from a human lymphoma. Published annually, the great decisions briefing book highlights eight of the most thoughtpro voking foreign policy challenges facing americans. Fdas guidance also contains information regarding the information that should be contained in each meeting request, as well as procedures for how fda intends to decide if a request should be granted. Example solutions that we provide to help achieve regulatory success include. Information on the stability program should be provided here or reference the drug manufacturers drug master. The fda promotes these goals through the implementation of standards regarding food, medications, medical devices, cosmetics, dietary supplements and tobacco. It can be defined as a short paper that quickly and effectively informs a decision maker about an issue. A good briefing note should be short, concise, clear, reliable.
Preparing for an fda advisory committee meeting mddi online. Apa citation style does not have a separate category for government publications. Members and invited guests of the peripheral and central nervous system drug advisory committee pcns ac. Media relations material could be placed at any level in the briefing book, depending on how broadly or narrowly it applies to activities. According to apa, government documents can be considered books, technicalresearch reports or. For example, to produce hiv1 in sufficient quantities for inactivated hiv1 vaccines, cell lines derived from human cd4positive t cells are preferred over primary t cells. Tips for writing a briefing document yourdictionary. Briefing book guidance for company general points for preparing a briefing book. The data do not suggest any need for dosing adjustment in patients with compromised renal function.
The investigators brochure a multidisciplinary document. A media event is an event that attracts lots of media coverage or an event to which the media has been invited e. Looking for some tips for writing a briefing document. Dont conduct training only in response to an impending inspection. 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. Take, for example, media relations, which is discussed above. Meetings to discuss clinical holds in which development is stalled and a new path forward should be discussed. The five steps to a successful meeting with fda note. The importance of fda approval packages and briefing. Generating the right content and questions for your meeting package can result in issues being identified before experiencing a clinical hold. 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. 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.
Treatment of the common cold is the most frequent use of otc combination products containing acetaminophen. Sponsor fda meetings pdufa 2 defined 3 types of meetings. How fda advisory committee members prepare and what influences them. Meeting decisions will be made within 14 days for type a meetings and 21 days for types b. Fda issues new draft guidance on submitting formal meeting. Writing a briefing book for a cder advisory committee. Information on citing and several of the examples were drawn from the publication manual of the american psychological association 7th ed.
The hub provides information, templates and resources to guide you through the ind process 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. Formal meetings between the fda and sponsors or applicants. The investigators brochure ib is a multidisciplinary document that summarises the main elements of an entire development programme to date. 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 all relevant information about the topic crossreferences to the. Guidance for industry food and drug administration. The briefing book covers 10 topics, including cybersecurity, chinas expanding power, u. Guidance on the briefing book for cadth scientific advice. It breaks down complex information into a short wellstructured document. This critical document is the companys opportunity to provide the agency with all essential facts about the product.
The book should be approximately 20 to 30 pages long, and should be organized in a way that complements the sponsors oral presentations. As background, this briefing package includes a brief description of the history of cell substrates used for viral vaccine manufacture in the u. Formal meetings with fda submit formalarchival submissions to the central document room submit desk paper copies of meeting packages to the regulatory project manager. Partnering with an fda consulting firm when preparing for and conducting a prenda meeting with the fda offers a number of benefits. Today, great decisions provides background information, current data and policy options for each of the eight issues and serves as the focal text for discussion groups. Health authority briefing documents also known as briefing packs, briefing packages, and briefing books are documents prepared by a pharmaceutical company. Despite this, you should avoid being repetitious in your response, and instead should simply reference the reader to the prior response where the relevant actions.
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 support academic investigators regulatory needs. This is a description of what the investigational product will be i. It is very important that the briefing document identify the issue in the most concise manner possible and propose a solution. Dispute resolution meetings as described in the code of federal regulations cfr, and in the guidance for industry formal dispute resolution. According to the fda cmc information constitutes the most frequent cause of clinical holds.
Briefing books are often accompanied by oral briefings that present the most important findings or recommendations. There is a multitude of unpublished data that only the fda knows thus providing even a brief summary of your. Plan and carry it out well in advance of any potential inspections. The study team will then need to send a briefing package 30 days prior to the meeting with finalized questions and information.
Review the fda preind feedback and provide strategic advice for advancing your product. Briefing books are often accompanied by short memos and oral briefings that glean important findings or recommendations. For example, if you dont have a dashboard, simply generate a briefing book and post it on your website for people to download. Joint meeting of the drug safety and risk management dsarm advisory committee and the anesthetic and analgesic drug products advisory committee aadpac may 34, 2016. The book is given to your organizations representative prior to the event so that he or she is. 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. Documentation submitted to facilitate an agency meeting, for example to request scientific advice in relation to a proposed drug development pathway. Global clinical development and best regulatory meeting. We have the necessary experience and knowledge to ensure that your prenda meeting goes as smoothly as possible, leaving you in a position to succeed. Or bibliographyptyp or biographyptyp or pubmed booksfilter or. If a manufacturer, seller or distributor fails to comply with fda regulations they will be liable for an assortment of felony charges. A guide to preparing subject matter experts to face the fda 5 training subject matter experts next is the process of training the smes you have chosen to represent the company. Coa regulatory submissions and support adelphi values.
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. Code of federal regulations, title 21, food and drugs, pt. Request meeting letter to division statement of meeting goals draft questions 2. The ind development process clinical research resource hub. For a beneficial prenda meeting, preparation is key.
A briefing note is a tool used to make decision makers informed about issues they are responsible for. Guidance on the briefing book for cadth scientific advice 3 november 22, 2016 2. 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. White papers and briefing books harvard university. Even though fda policy is that observations should not be repeated, it is very common for the same event or set of facts to be listed as examples in multiple fda 483 observations.
In addition, there should be a short description of how the drug substance is prepared including any excipients that are added for longterm stability. Briefing book ceftaroline fosamil for injection page 1 of 195 september 7, 2010 1. Fda analysis of a sample of cases from their adverse event reporting system or aers, 2005. 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. Immediately necessary for an otherwise stalled drug development program to proceed. Russia relations, north koreas nuclear weapons ambitions and tensions with iran. Harborside financial center, plaza v jersey city, nj 07311 ceftaroline fosamil for injection in complicated skin and skin structure infections. 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.
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