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💊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The Food and Drug Administration (FDA or the Agency) is extending the comment period for the draft guidance for industry entitled "Expedited Program for Serious Conditions--Accelerated Approval of Drugs and Biologics" that appeared in the Federal Register of December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 In the notice of availability for the draft guidance, FDA requested comments on the draft guidance.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.

🚫FDA Revokes FD&C Red No. 3 for Food and Ingested Drugs

The Food and Drug Administration (FDA or we) is granting a color additive petition submitted by Center for Science in the Public Interest, et al., by repealing the color additive regulations that permit the use of FD&C Red No. 3 in foods (including dietary supplements) and in ingested drugs. The petitioners provided data demonstrating that this additive induces cancer in male rats. Therefore, FDA is revoking the authorized uses in food and ingested drugs of FD&C Red No. 3 in the color additive regulations.

⚖️HRSA 340B Drug Pricing Program

In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.