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Agreement Meeting Fda

The purpose of this guide is to discuss ways to obtain FDA feedback on scientific and regulatory issues for sponsors of combination products and to describe best practices for FDA and sponsors when interacting on these issues. These interactions can be done through application-based mechanisms (usually the most effective and effective approach), such as for example. B the pre-submission process used in cdRH and CBER and the formal meetings used in CDER and CBER, or through product combination meetings (CPAMs). The value of the FDA`s written registration resulting from the pre-sub cannot be underestimated. Indeed, the FDA advises that, to formally document unm written feedback, “applicants are responsible for developing a draft protocol for a pre-submission meeting or conference call and forward the draft minutes to the FDA by email within 15 calendar days of the meeting.” If the FDA detects discrepancies, it will provide the applicant with changes to the draft protocol. The report drawn up becomes the last report 15 calendar days after receipt of the treatments from the FDA. [10] The pre-sub program is useful for many regulatory strategies, but when it comes to medical devices, it is particularly useful for those who do not have a clear regulatory pathway, 2) use a new technology or 3) have indications for the use they call “the first device of a type”. [5] Although not required, the net result of a pre-sub is given in a targeted manner, written comments from the FDA. Ad compliance with such feedback is of great value in terms of quality and compliance and is highly desirable for devices that may need more information to secure a submission accepted by the FDA for filing. In short, early fda feedback tends to improve the quality of data for inclusion in the actual FDA filing. However, pre-subs must be done before compiling documents or device studies and it is important to take into account pre-sub-deadlines (75-90 days for meetings or conference calls, 21 days for urgent public health issues). [6] We are publishing these guidelines in accordance with the Agency`s ongoing commitment to improve clarity and transparency with respect to regulatory considerations for combination products and in accordance with the mandate under Section 503(g)(8)(C)(vi) of the FD&C Act (21 USC 353(g),8). C)(vi)), added by section 3038 of the Cures Act.

Section 503(g)(8)(C)(vi) requires the FDA to provide a definitive guide regarding: (1) the structured process for managing interactions prior to submission with sponsors who develop combination products; (2) best practices to ensure that FDA feedback on such pre-submission interactions is the Best Advice to the Agency based on the information provided during such interactions prior to submission; and (3) how CPAMs relate to other types of FDA meetings, the information to be submitted to a CPAM, and the form and content of agreements entered into through a CPAM. To put it simply, pre-sub is a formal mechanism for requesting feedback from the FDA before filing a medical device application….

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