gov/). How are regulatory requirements determined? Sometimes it is obvious where a product will be reviewed. A small molecule that will be used to treat depression or schizophrenia will be reviewed in the Division of Neurological Drug Products. If the designation is not clear, in order to determine which center and which group within

that center will have primary product review, it may be I-BET151 nmr appropriate to ask the FDA for clarification. Another alternative is to submit a Request for Designation.5 In the Request for Designation, the sponsoring company may suggest what the primary reviewing center should be. Since an original investigational new drug (IND) is submitted to the Document Control Room at FDA, Inhibitors,research,lifescience,medical the FDA will designate the primary reviewing center and division if the sponsor does nothing. The latter strategy is rarely adopted: it. is almost, always a. good idea to meet with FDA prior to an IND Inhibitors,research,lifescience,medical submission. Contacting the FDA What should be the initial exposure to FDA rules and regulations? It is a good idea to be very familiar with the regulations. The formal source of regulations

is Title 21 of the CFR. FDA guidance documents for specific issues are also available. Consultants, including regulatory attorneys, are available for consultations. Companies such as contract research organizations (CROs) may also have regulatory specialists as part of their services. How are specific toxicological, chemical, Inhibitors,research,lifescience,medical and clinical requirements determined? There are publications available in the Federal Register as Inhibitors,research,lifescience,medical well as online at the FDA web site. It is a good idea to review these publications, and then have access to experts who are knowledgeable with specific requirements. It is important to distinguish those vendors who provide services such as toxicology and manufacturing from those

who plan toxicology and manufacturing programs. Just because a site can perform services, does not mean that they know how to design a development program. What shoidd be the initial contact Inhibitors,research,lifescience,medical with the FDA and how shoidd it be carried out? After completing the above background tasks, make an initial call to the division of interest and briefly introduce yourself. Discuss the project and its status and discuss the option of an initial meeting. If a meeting is decided upon, establish action items, plan Dipeptidyl peptidase meeting dates, send in the briefing document with an agenda, and prepare for the meeting. Find out how many copies the FDA needs. Put in proposed meeting dates and blackout dates, let the FDA know when the briefing document has been sent, and confirm receipt over the phone. Preparation for the initial FDA meeting In general, it is usually a good idea to assign one person to organize and champion the meeting. It is critical to prepare a well-thought-out document, containing the meeting agenda; attendees; rationale for the product; chemical characteristics of the drug and how it.