Please take the drug i.e. Product name Guselkumab (Tremfya) and do the analysis of pre-IND meeting request and Packaging request.
Presume that the study to be conducted within the United States is a Phase 3 study with Phases 1 and 2 being conducted ex-US.
Arrange the answer in following pattern-
Pre-IND Meeting request-
1. Product name.
2. Application number (if applicable).
3. Chemical name and structure.
4. Proposed indication(s) or context of product development.
5. Type of meeting being requested (i.e., Type B, or Type C).
6. A brief statement about the purpose and objectives of the meeting. This statement should include a brief background of the issues underlying the agenda. It also can include a summary of completed or planned studies and clinical trials or data that the sponsor or applicant intends to discuss at the meeting, the general nature of the critical questions to be asked, and where the meeting fits in overall development plans. Although the statement should not provide detailed documentation of trial designs or completed studies, and clinical trials, it should provide enough information to facilitate understanding of the issues, such as a small table that summarizes major results.
7. A proposed agenda.
8. A list of proposed questions, grouped by discipline. For each question there should be a brief explanation of the context and purpose of the question.
9. A list of all individuals with their titles and affiliations who will attend the requested meeting from the sponsor’s or applicant’s organization and consultants.
10. A list of FDA staff, if known, or disciplines asked to participate in the requested meeting.
11. Suggested dates and times (e.g., morning or afternoon) for the meeting that are within or beyond the appropriate time frame of the meeting type being requested.
12. The format of the meeting (i.e., face to face, teleconference, or videoconference)
Meeting Package Request-
1. Product name and application number (if applicable).
2. Chemical name and structure.
3. Proposed Indication
4. Dosage form, route of administration, and dosing regimen (frequency and duration).
5. An updated list of sponsor or applicant attendees, affiliations, and titles.
6. A background section that includes the following:
a. A brief history of the development program and the events leading up to the meeting.
b. The status of product development (e.g., the target indication for use).
7. A brief statement summarizing the purpose of the meeting.
8. A proposed agenda.
9. A list of the final questions for discussion grouped by discipline and with a summary for each question to explain the need or context for the question.
10. Data to support discussion organized by discipline and question. For example, for an end-of-phase 2 meeting, this section should include the following, if not already provided in the background section (refer to item #6 above): description and results of controlled trials conducted to determine dose-response information; adequately detailed descriptors of planned phase 3 trials identifying major trial features such as trial population, critical exclusions, trial design (e.g., randomization, blinding, choice of control group, with explanation of the basis for any noninferiority margin if a noninferiority trial is used), choice of dose, primary and secondary trial endpoints; and major analyses (including planned interim analyses and adaptive features, and major safety concerns).
Reference link-
https://www.fda.gov/media/72253/download
https://www.accessdata.fda.gov/cder/sb-navigate/topic3/topic3/da_01_03_0280.htm
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-meetings-between-fda-and-sponsors-or-applicants-pdufa-products
Please give me answer this is my last attempt
