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💊Janssen Pharmaceuticals Applies for Controlled Substances Importer Registration

Janssen Pharmaceuticals Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

💊Proposed Production Activity Notification for Lilly del Caribe, Inc.

Lilly del Caribe, Inc. submitted a notification to the Foreign-Trade Zones Board regarding a proposed production activity for pharmaceutical products in Carolina, Puerto Rico. The notice outlines the specific foreign-status materials involved and invites public comment on the proposal, detailing potential benefits associated with conducting production under FTZ procedures.

💊DEA Notice

Medi-Physics Inc. DBA GE Healthcare has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.

📋DEA Notice

Vici Health Sciences, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

💊VHG Labs Applies for Controlled Substance Import Registration

VHG Labs DBA LGC Standards has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

💊Noramco's Application for Controlled Substances Registration Notice

Noramco has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.

💊DEA Notice

Veranova, L.P., has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

🏭Authorization of Production Activity for Merck in Foreign-Trade Zone

📄FDA Extends Comment Period for Accelerated Approval Guidance

The Food and Drug Administration (FDA or the Agency) is extending the comment period for the draft guidance for industry entitled "Expedited Program for Serious Conditions--Accelerated Approval of Drugs and Biologics" that appeared in the Federal Register of December 6, 2024. In the notice of availability for the draft guidance, FDA requested comments on the draft guidance. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

💊FDA Proposes Refusal of TRADIPITANT Drug Application

The Director of the Center for Drug Evaluation and Research (Center Director) at the Food and Drug Administration (FDA or Agency) is proposing to refuse to approve a new drug application (NDA) submitted by Vanda Pharmaceuticals, Inc. (Vanda), for TRADIPITANT capsules, 85 milligrams (mg), in its present form. This notice summarizes the grounds for the Center Director's proposal and offers Vanda an opportunity to request a hearing on the matter.