FDA Communications/Meetings

Question 0

21 CRF

Answer 0

Formal Evidentiary Public Hearing

Question 1

21 CFR 10

Answer 1

Administrative Practices and Procedures

Question 2

21 CFR 13

Answer 2

Public Hearing before a Public Advisory Committee

Question 3

21 CFR 15

Answer 3

Public Hearing before the Commissioner

Question 4

21 CFR 16

Answer 4

Regulatory Hearing Before the Food and Drug Administration

Question 5

21 CR 312

Answer 5

Investigational New Drug Applicatioin

Question 6

21 CFR 812

Answer 6

Investigational Device Exemptions

Question 7

4 type of regulatory communications with FDA

Answer 7

1. Regulatory Communications
2. Product Application Meetings
3. Administrative Meetings or Communications
4. Public Administrative Proceedings

Question 8

Citizen Petitions

Answer 8

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

Question 9

Suitability Petitions

Answer 9

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.

Question 10

Advisory opinion

Answer 10

FDAs formal position on a matter.

Question 11

Pharmaceutical or Biologic Product Application Meetings

Answer 11

Type A, Type B and Type C

Question 12

Type A Meetings

Answer 12

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

Question 13

Type B Meetings Background

Answer 13

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

Question 14

Types of Type B Meetings

Answer 14

• 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

Question 15

Type C Meetings

Answer 15

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

Question 16

Medical Device Application Meetings

Answer 16

• Agreement
• Determination
• Pre-Investigational Device Exemption (Pre-IDE)
• Pre-PMA
• PMA day 100

Question 17

Agreement Meeting

Answer 17

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.

Question 18

Determination Meetings

Answer 18

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.

Question 19

Pre-IDE Meetings

Answer 19

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.

Question 20

Pre-PMA Meetings

Answer 20

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.

Question 21

PMA 100 day Meeting

Answer 21

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.

Question 22

Administrative Meetings/Communications

Answer 22

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.

Question 23

Public Administrative Proceedings

Answer 23

• Formal Evidentiary hearings
• Public Board of Inquiry
• Hearing before the Commissioner
• Advisory Committee Meetings

Question 24

Evidentiary Hearing

Answer 24

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)

Question 25

Board of Inquiry

Answer 25

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.

Question 26

Public Hearing

Answer 26

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.

Question 27

Advisor Committee Meetings

Answer 27

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.