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3 paź 2022 · 510 (k) Submission Process. Send Medical Device eSTAR and eCopy Premarket Submissions Online. October 3, 2022 - The FDA is announcing that you may now send electronic copy (eCopy) or electronic...
27 cze 2024 · FDA recently released a new eSTAR template for device pre-submissions and 513(g) Requests for Information, referred to as PreSTAR. A pre-submission provides the submitter an opportunity to obtain FDA feedback prior to a planned medical device premarket submission.
A strategic approach typically follows these best practices: Don’t panic. IRs are a common occurrence in the NDA and BLA review process. Respond promptly. Unlike a Form 483 which you must respond to within 15 days, an IR doesn’t have a specific response due date.
This Standard Operating Policy and Procedure (SOPP) serves as a guide for Center for Biologics Evaluation and Research (CBER) staff for issuing Information Request (IR) communications for...
HCDMs want to receive information about new products and new indications prior to FDA approval. 1,2 Such information helps HCDMs to more accurately plan for future drug approvals and reimbursement decisions, and forecast their future budgets. 1
This guidance explains how FDA will issue and use an information request (IR) and/or a 15 discipline review letter (DRL) during the review of an original abbreviated new drug application 16 (ANDA) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
Our free guide, “How to Successfully Respond to an FDA Information Request (IR),” will equip you with the knowledge and strategies you need to: Understand the reasons behind IRs and how to respond effectively. Craft clear and concise responses that address the FDA’s specific questions and concerns.
