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FDA Acknowledgement of Submission from Hyman Phelps McNamara

FDA CDER issued an acknowledgement letter to Hyman, Phelps & McNamara, P.C. regarding a submission under docket FDA-2026-P-3664-0002. The acknowledgement confirms receipt of the submission but no substantive regulatory action is detailed in the available metadata.

ENFLONSIA Patent Extension Consultation

The FDA is seeking public comments on an ENFLONSIA patent extension application (Docket FDA-2025-E-3626-0006). Comments must be submitted by June 2, 2025 via Regulations.gov. This consultation follows standard FDA procedures for pharmaceutical patent-related matters.

FDA complaint, CTP author, posted 3rd Apr

FDA complaint, CTP author, posted 3rd Apr

Determination of Regulatory Review Period for EMRELIS Patent Extension

FDA has determined the regulatory review period for EMRELIS, a human biological product, and published this determination as required by law. The notice allows interested parties to comment on the accuracy of dates and to petition FDA regarding due diligence during the review period.

Medical Device Variance Renewal - Redhouse Productions

FDA CDRH approved a variance renewal for Redhouse Productions (FDA-2023-V-2753-0004). The variance allows deviation from standard medical device manufacturing requirements under specific conditions. The renewal maintains previously granted flexibilities for the regulated entity.

ENFLONSIA Regulatory Review Period Determination

FDA has determined the regulatory review period for ENFLONSIA, a human biological product, as required by 35 U.S.C. 156 for patent extension purposes. The notice invites public comment on whether the published dates are incorrect and allows interested parties to petition FDA regarding the applicant's due diligence during the review period.

Variance Application from BF Light Shows, Michigan

FDA CDRH received a variance application from BF Light Shows, a Michigan-based entity, seeking regulatory relief or alternative compliance pathway under FDA electronic product radiation control requirements. The application was filed under docket FDA-2026-V-2878.

VYLOY Patent Extension Regulatory Review Period Determination

The FDA has determined the regulatory review period for VYLOY, a human biological product, and published this notice as required under 35 U.S.C. 156. The notice invites comments on whether any published dates are incorrect by June 2, 2026, and allows interested persons to petition FDA regarding due diligence by September 30, 2026.

Customer Service Satisfaction Surveys - PRA Comment Request

The FDA is seeking public comments on proposed customer service satisfaction surveys under the Paperwork Reduction Act of 1995. The 60-day comment period closes June 2, 2026. This is a routine information collection request; no new burdens are proposed as it involves existing customer service survey collections.

Complaint Regarding Potential Regulatory Violation

FDA posted a complaint under docket FDA-2026-H-3081-0001 on April 3, 2026. The complaint, authored by CTP (Center for Tobacco Products), relates to a potential regulatory violation. No documents are currently available for review on regulations.gov.