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FDA Requests Comments on Medical Device Premarket Approval Information Collection Under PRA

FDA Premarket Approval, Comment Period Ends Jun 9

Variance Approval Letter for Shane Parker

FDA CDRH issued a variance approval letter to Shane Parker under docket FDA-2025-V-5013. The variance grants an exception or deviation from standard CDRH regulatory requirements for a specific medical device matter. The approval letter (redacted version available) represents a binding regulatory determination by FDA.

ANDA vs 505(b)(2) Applications

FDA issued guidance clarifying distinctions between Abbreviated New Drug Applications (ANDAs) and 505(b)(2) applications for drug approvals. The document helps pharmaceutical manufacturers determine the appropriate regulatory pathway based on their drug product characteristics and supporting data requirements.

Food Additive Petitions Comments Due Jun 9

FDA is soliciting public comments on information collection requirements for food and color additive petitions, including labeling, master file submissions, and electronic submissions using Form FDA 3503. The 60-day comment period closes June 9, 2026. Comments will be posted to Docket No. FDA-2026-N-2743 on regulations.gov.

FDA DMB Acknowledgement Letter to Emprise Pharma LLC

FDA Division of Manufacturing Standards (DMB) issued an acknowledgement letter to Emprise Pharma LLC on behalf of Shandong New Time Pharmaceutical Co., Ltd on April 10. The letter confirms receipt or filing status of a submission related to pharmaceutical manufacturing. This is standard administrative correspondence and does not constitute approval, denial, or any substantive regulatory determination.

Color Additive Certification PRA Extension, Comments Due June 9, 2026

FDA is soliciting public comments on extending an existing information collection under the Paperwork Reduction Act concerning color additive certification. Comments must be submitted by June 9, 2026. This PRA notice follows standard federal procedures for renewing agency data collection authorizations.

CDRH Acknowledgment Letter to Shane Parker - FDA-2025-V-5013

FDA CDRH issued an acknowledgment letter to Shane Parker in response to submission FDA-2025-V-5013. The acknowledgment letter confirms receipt of the submission but the actual document content is not publicly available due to personally identifiable information protections.

Environmental Impact Statement Background Material

FDA published background material supporting an Environmental Impact Statement (EIS) for a pre-market submission (FDA-2026-P-3840). The document provides supporting context for environmental review of the regulated product or facility. Interested parties may review the materials on Regulations.gov.

GSK Withdraws Wellcovorin (Leucovorin Calcium) NDA Approval

FDA withdrew approval of NDA 018342 for Wellcovorin (leucovorin calcium) tablets at GlaxoSmithKline's written request. GSK notified FDA that the drug products are no longer marketed. Existing inventory may continue to be dispensed until depleted or reaching expiration dates.

CMS PRA Comment Request: Agency Information Collection Activities

CMS published a Paperwork Reduction Act notice seeking public comments on proposed information collection activities related to agency programs. The notice invites feedback on the burden estimates, data collection methods, and necessity of the proposed information collections. Comments are due within 60 days of publication.