Pharma & Life Sciences

FDA Survey Comment Form

The Food and Drug Administration (FDA) has opened a public comment period on a survey (Docket FDA-2026-N-2740-0001) via regulations.gov. The comment period remains open until June 2, 2026. This is a standard consultation seeking public input on an unspecified FDA survey topic.

Newsletter on Transplantation and Donation Practices

EDQM published a newsletter addressing transplantation and donation practices. The newsletter appears to be an informational communication for healthcare professionals and stakeholders involved in organ donation and transplantation across Europe. Specific content details were inaccessible at the time of this review.

Technetium Tc 99m Albumin Aggregated Injection Revision

USP's Small Molecules 4 Expert Committee has issued a Notice of Intent to Revise the Technetium Tc 99m Albumin Aggregated Injection monograph due to a compliance concern with the Appearance acceptance criterion. Comments with supporting data prompted this action. The proposed revision is targeted for an August 1, 2026 official date and is expected to be published as a Revision Bulletin on July 31, 2026.

UK and US deepen regulatory cooperation on medical devices

MHRA and FDA announced strengthened cooperation on medical device regulation to support faster access to safe, innovative technologies for patients in both countries. The regulators will explore mutual recognition mechanisms, reduce duplication for manufacturers, and streamline approval processes while maintaining independent safety standards. The UK MedTech sector employs over 195,000 people.

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.

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.

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.

VYLOY Patent Extension Regulatory Review Period Determination

The Food and Drug Administration has determined the regulatory review period for VYLOY, a human biological product, for purposes of patent extension under federal law. The notice invites public comments on the accuracy of published dates by June 2, 2026, and allows interested persons to petition FDA regarding due diligence by September 30, 2026. This determination affects patent extension calculations for the branded drug manufacturer.

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.