Pharma & Life Sciences

Background Material Supporting Proposed Regulatory Action

The FDA published background material supporting docket FDA-2026-P-3665. This document provides supplementary information related to a proposed regulatory action in the pharmaceutical or medical product space. The docket is open for public review and potential comment submission.

ZIIHERA Patent Extension Comment Form

FDA has opened a public comment period on Regulations.gov for a patent extension related to ZIIHERA. The comment form is accessible for submission of feedback by interested parties including pharmaceutical companies, manufacturers, and individuals. The docket number is FDA-2025-E-0372-0005.

ENCELTO Regulatory Review Period Determination for Patent Extension

The FDA has determined the regulatory review period for ENCELTO, a human biological product, and published this notice as required by law for patent extension purposes. Any person may submit comments on the accuracy of the published dates by June 2, 2026, or petition FDA regarding due diligence by September 30, 2026.

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.

Patent Extension Comment Period

FDA has opened a 60-day public comment period for a patent extension matter under docket FDA-2025-E-3074-0006. The agency is seeking stakeholder input on the EMRELIS patent extension proposal. Interested parties may submit comments through Regulations.gov.

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.

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.

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.