What is a Q-sub FDA?
Page 13. Q-Sub Type: Pre-Submissions. • A formal written request for feedback from FDA to help. guide product development and/or application preparation.
What is Q submission?
The Q submission program, initiated in 2019, is a broader version of the previous pre-IDE program. Q-Sub refers to the system used to track the collection of interactions with FDA, including Pre-Submissions (Pre-Subs), Submission Issue Requests (SIRs), Study Risk Determinations, and other additional requests.
What is the pre-Sub meeting FDA?
A Pre-Sub includes a formal written request from a submitter for feedback from FDA that is provided in the form of a formal written response or, if the submitter chooses, formal written feedback followed by a meeting in which any additional feedback or clarifications are documented in meeting minutes.
What is a pre-submission meeting?
Pre-submission meetings provide an opportunity for advice and guidance before submission of a medicines dossier, as well as an opportunity for the applicant to meet WHO medicines assessors who will be involved in assessing their product.
When should the FDA pre submission program be used?
However, Pre-Subs should be conducted prior to compiling any device documents or studies and it is important to keep in mind the Pre-Sub lead times (75-90 days timeframe for meeting or teleconference, 21 days for urgent public health issues.)
How long does an FDA pre submission take?
approximately 60-70 days
It takes approximately 60-70 days to receive a written FDA response to a pre-submission.
When should the FDA pre-submission program be used?
How long does an FDA pre-submission take?
What is Type C meeting?
A Type C meeting is any meeting other than a Type A or Type B meeting between CBER or CDER and a sponsor or applicant regarding the development and review of a product. Type C meetings should be scheduled to occur within 75 days of FDA receipt of the written. meeting request.
Where can you submit comments and changes needed or ask questions to FDA?
Call 1-888-INFO-FDA (1-888-463-6332). Call the FDA Consumer Complaint Coordinator for your state or region.
Is there a fee for an FDA pre-submission?
How long does it take, and is there a fee? It takes approximately 60-70 days to receive a written FDA response to a pre-submission. There are no fees to submit.
What is Type B meeting?
Type B meetings, which are routine meetings occurring at pre-defined endpoints between FDA and a sponsor. Meetings typically occur right after or right before the submission of clinical data or a new drug filing.
What is q sub FDA?
US FDA Pre-Sub (Q-Sub) Consulting for Medical Devices. The US Food and Drug Administration’s Pre-Submission Program (Pre-Sub, formerly known as the Pre-IDE Program) allows medical device and in vitro diagnostic (IVD) manufacturers to discuss specific aspects of the regulatory process and requirements with FDA experts.
What is FDA draft guidance?
This draft guidance is intended to assist IRBs, clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in carrying out their responsibilities related to informed consent.
What are the FDA regulations?
Voluntary Qualified Importer Program (VQIP) Under the FDA Food Safety Modernization Act (FSMA),the VQIP was established to enable the expedited importation of any FDA-regulated human and animal foods into
What is a FDA guidance document?
(1) Guidance documents are documents prepared for FDA staff, applicants/sponsors, and the public that describe the agency’s interpretation of or policy on a regulatory issue.