Latest Federal Register Notices

Comments Extended on Device Modeling/Simulation Guide
2/4/2022 Federal Register notice: FDA is extending the comment period for a 12/23 notice on a draft guidance entitled “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions.” Comments should now be submitted by 3/4. To view the notice, click here.

Info Collection on FDA Communications Testing
2/3/2022 Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Generic Clearance for Quantitative Testing for the Development of FDA Communications” (OMB Control Number 0910-0865). The collection covers FDA’s use of quantitative social/behavioral science data collection techniques (i.e., surveys and experimental studies) to test consumers’ reactions to FDA communications or educational messaging about FDA-regulated food and cosmetic products, dietary supplements, and animal food and feed. To view the notice, click here.

Device Export Foreign Approval Letters Info Collection
2/3/2022 Federal Register notice: FDA is seeking comments on an information collection extension entitled “Export of Medical Devices; Foreign Letters of Approval” (OMB Control Number 0910-0264). Section 801(e)(2) of the Federal Food, Drug, and Cosmetic Act provides for the exportation of an unapproved device under certain circumstances. The agency requires written authorization from the appropriate office within the foreign government approving the device importation. An alternative to obtaining written authorization from the foreign government is to accept a notarized certification from the responsible company that the product is not in conflict with the foreign country’s laws. To view the notice, click here.

Final Guidance on Good ANDA Submission
2/2/2022 Federal Register notice: FDA has made available a final guidance entitled “Good ANDA Submission Practices.” The document highlights common, recurring deficiencies that may lead to an ANDA approval delay. It also makes recommendations to applicants on how to avoid the deficiencies and minimize the number of review cycles. To view the notice, click here.

Guide on Revising ANDA Labeling
2/2/2022 Federal Register notice: FDA is making available a draft guidance entitled “Revising ANDA Labeling Following Revision of the RLD Labeling.” This guidance provides recommendations for updating ANDA labeling following revisions to the reference-listed drug (RLD) labeling, including information on how to identify RLD labeling updates and how to submit labeling updates. To view the notice, click here.

Guide on ANDA Info Requests/Review Letters
2/1/2022 Federal Register notice: FDA is making available a final guidance entitled “Information Requests and Discipline Review Letters Under GDUFA.” The document explains how FDA will issue and use an information request and discipline review letter during the assessment of an original ANDA. To view the notice, click here.