FDA Communications/Meetings Flashcards
21 CRF
Formal Evidentiary Public Hearing
21 CFR 10
Administrative Practices and Procedures
21 CFR 13
Public Hearing before a Public Advisory Committee
21 CFR 15
Public Hearing before the Commissioner
21 CFR 16
Regulatory Hearing Before the Food and Drug Administration
21 CR 312
Investigational New Drug Applicatioin
21 CFR 812
Investigational Device Exemptions
4 type of regulatory communications with FDA
- Regulatory Communications
- Product Application Meetings
- Administrative Meetings or Communications
- Public Administrative Proceedings
Citizen Petitions
a formal written request to FDA asking the agency to take or refrain from taking an administrative action. FDA must respond within 180 days of receipt. Should contain: action requested, statement of grounds, environmental impact, economic impact, certification by the submitter
Suitability Petitions
Type of Citizen Petition. Used to file an abbreviated application for a new human or animal drug whose active ingredients, route of administration, dosage form or strength differ from that of the approved drug. FDA will approve or deny within 90 days of submission date.
Advisory opinion
FDAs formal position on a matter.
Pharmaceutical or Biologic Product Application Meetings
Type A, Type B and Type C
Type A Meetings
Reserved for dispute resolution, discussion of clinical holds or Special Protocol Assessments. Should be held within 30 days of FDAs receipt of a written request. Requests should include: complete list of questions needed to be resolved, explain the rationale for the request the issues to be discussed. Request should be sent to the correct review division
Type B Meetings Background
Pivotal development meetings that occur prior to progression to the next development stage. FDA should schedule meeting 60 days of request receipt. Requests should include: complete list of questions needed to be resolved, explain the rationale for the request the issues to be discussed. Request should be sent to the correct review division
Types of Type B Meetings
- Pre-Investigational New Drug (IND)
- End-of-Phase 1 Meetings
- End of Phase 2 meetings/Pre-Phase 3 meetings
- Pre-NDS/BLA (Biologic License Application) meetings
Type C Meetings
Any other type of meeting not listed for A or B. FDA must schedule within 75 days of receipt of request. Requests should include: complete list of questions needed to be resolved, explain the rationale for the request the issues to be discussed. Request should be sent to the correct review division
Medical Device Application Meetings
- Agreement
- Determination
- Pre-Investigational Device Exemption (Pre-IDE)
- Pre-PMA
- PMA day 100
Agreement Meeting
Reach concurrence on the key parameters of the investigational plan for clinical study before applying for an Investigational Device Exemption (IDE). Agreement is binding on FDA and can’t be changed unless sponsor agrees in writing or there is substantial scientific issue in determining safety and efficacy. Requests must be submitted in writting.
Determination Meetings
Limited to PMAs or product development protocol (PDP) applications. Purpose is to determine the type of valid scientific evidence required to demonstrate safety and efficacy for it’s intended use.
Pre-IDE Meetings
Expedite the regulatory review process and minimize product development delays. Sponsor has an opportunity to present development plan to FDA and obtain official acceptance. Does not need to occurs before an IDE is filed.
Pre-PMA Meetings
Guide development of PMA submissions. Topics include: preclinical testing results not included in the IDE submission, reliability testing, CMC issue and clinical results. Notify appropriate review division of intent to request this type of meeting before making the official request.
PMA 100 day Meeting
Scheduled to occur 100 days after PMA is accepted for filing. provides an opportunity to discuss applications review status and obtain any additional information required to complete the PMA review. FDA informs the applicant of any deficiencies and any additional information required to correct them or they complete the review.
Administrative Meetings/Communications
Ad hoc, private, 2way communications between FDA and outside parties on matters within FDAs jurisdiction. FDA or sponsor can request the meeting to address scientific issues that warrant discussion with FDA. Following the meeting FDA generally with issue non-binding advice.
Public Administrative Proceedings
- Formal Evidentiary hearings
- Public Board of Inquiry
- Hearing before the Commissioner
- Advisory Committee Meetings
Evidentiary Hearing
Equivalent to a civil court hearing. Occur when specifically provided by law, mandated by congress or when ordered by FDA commissioner in order to discuss public health concerns for a product or review proposed guidances such as Risk Evaluation and Mitigation Strategies (REMS)
Board of Inquiry
Called when specifically authorized by regulation, at the discretion of the FDA commissioner or as an alternative to the evidentiary public hearing. Reviews medical, scientific and technical issues.
Public Hearing
Occur when the commissioner determines that it is in the public interest t permit persons to preset information and view at a public hearing on matters pending before the agency. Solicit general views and information on a particular topic.
Advisor Committee Meetings
Held by FDA to obtain recommendations and advice from subject matter experts on the safety and efficacy of foods, drugs, biologics and medical devices. Is a public forum and minutes are published. Votes by the committee are recommendations and are non-binding.
