Monthly FDA Guidance and Regulatory News Review - March 2025

Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA)  that are pertinent to the governance of clinical trials and drug, biologic, or medical device development and approval. 

FDA Final Guidance:

Data Standards Catalog (published 24-Mar-2025)
Download FDA Guidance

Study Data Technical Conformance Guide - Technical Specifications Document (published 27-Mar-2025)
Download FDA Guidance

Monthly FDA Approvals

Approval Date: 03/07/2025
Drug Name: OMLYCLOBLA #761399
Active Ingredients: OMALIZUMAB-IGEC
Submission Classification*:
Review Priority**:
Company: CELLTRION INC

Approval Date: 03/13/2025
Drug Name: EPINEPHRINENDA #215425
Active Ingredients: EPINEPHRINE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: FRESENIUS KABI USA

Approval Date: 03/13/2025
Drug Name: ARBLINDA #218772
Active Ingredients: LOSARTAN POTASSIUM
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: SCIENTURE

Approval Date: 03/14/2025
Drug Name: TYENNEBLA #761449
Active Ingredients: TOCILIZUMAB-AAZG
Submission Classification*:
Review Priority**:
Company: FRESENIUS KABI USA

Approval Date: 03/17/2025
Drug Name: HEMICLORNDA #218647
Active Ingredients: CHLORTHALIDONE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: PRM PHARMA

Approval Date: 03/20/2025
Drug Name: GOZELLIXNDA #219592
Active Ingredients: KIT FOR THE PREPARATION OF GALLIUM GA 68 GOZETOTIDE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: TELIX INNOVATIONS SA

Approval Date: 03/25/2025
Drug Name: BLUJEPANDA #218230
Active Ingredients: GEPOTIDACIN MESYLATE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: GLAXOSMITHKLINE LLC

Approval Date: 03/25/2025
Drug Name: BOMYNTRABLA #761398
Active Ingredients: DENOSUMAB-BNHT
Submission Classification*:
Review Priority**:
Company: FRESENIUS KABI USA LLC

Approval Date: 03/25/2025
Drug Name: CONEXXENCEBLA #761398
Active Ingredients: DENOSUMAB-BNHT
Submission Classification*:
Review Priority**:
Company: FRESENIUS KABI USA LLC

Approval Date: 03/25/2025
Drug Name: DENOSUMAB-BNHTBLA #761398
Active Ingredients: DENOSUMAB-BNHT
Submission Classification*:
Review Priority**:
Company: FRESENIUS KABI USA LLC

Approval Date: 03/26/2025
Drug Name: VYKAT XRNDA #216665
Active Ingredients: DIAZOXIDE CHOLINE
Submission Classification*: Type 2 - New Active Ingredient
Review Priority**: Priority
Company: SOLENO THERAPEUTICS INC

Approval Date: 03/28/2025
Drug Name: QFITLIANDA #219019
Active Ingredients: FITUSIRAN INJECTION
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: GENZYME CORP

Upcoming Advisory Board Meetings

05/05/2025 Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Meeting- 08:00 AM EDT to 05:00 PM EDT

Stakeholders seek clarity, use of international standards in FDA protocol deviations guidance (published 03-Mar-2025)
Read Article on RAPS.org

Experts: Cuts at FDA could jeopardize US standing in clinical research, product innovation (published 03-Mar-2025)
Read Article on RAPS.org

FDA warns Indian firm over cleanliness and poor record keeping, US drugmaker over investigation failures (published 04-Mar-2025)
Read Article on RAPS.org

DOGE claims $30M savings from canceling 30 FDA leases (published 04-Mar-2025)
Read Article on RAPS.org

USP publishes list of vulnerable medicines susceptible to shortages (published 05-Mar-2025)
Read Article on RAPS.org

FDA’s St. Louis drug testing lab to remain open despite DOGE claim (published 05-Mar-2025)
Read Article on RAPS.org

Experts propose restricting trademarks on accelerated approval drugs to speed confirmatory trials (published 07-Mar-2025)
Read Article on RAPS.org

FDA reviewers, inspectors, and investigators excluded from $25K buyout offer (published 10-Mar-2025)
Read Article on RAPS.org

EMA spells out data access policy for shortage monitoring platform (published 10-Mar-2025)
Read Article on RAPS.org

FDA admonishes Chinese device testing lab for falsified studies, copied data (published 11-Mar-2025)
Read Article on RAPS.org

Stakeholders want FDA to address alternatives, sample retention in biopsy guidance (published 11-Mar-2025)
Read Article on RAPS.org

Stakeholders: FDA should align pulse oximeter guidance with updated ISO standard (published 12-Mar-2025)
Read Article on RAPS.org

FDA makes flu vaccine recommendations after canceled VRBPAC, closed-door meeting (published 13-Mar-2025)
Read Article on RAPS.org

Experts: Strong design controls are key to FDA device approval (published 13-Mar-2025)
Read Article on RAPS.org

Experts recommend being tactful, concise, and evidentiary when submitting guidance comments (published 14-Mar-2025)
Read Article on RAPS.org

Study: FDA offers flexibility, expedited review to first-in-class drugs more often than EMA (published 17-Mar-2025)
Read Article on RAPS.org

FDA’s return-to-office chaos, probationary workers reinstated, and demotion fears (published 17-Mar-2025)
Read Article on RAPS.org

Study: Nearly one-third of device adverse event reports were late or missing data (published 18-Mar-2025)
Read Article on RAPS.org

Experts: Trump’s FDA moves create uncertainty, opportunities for other regulators (published 18-Mar-2025)
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Some FDA staff considering quitting due to Trump’s RTO policy (published 19-Mar-2025)
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DIA Europe: ICH updates on pregnant, breastfeeding individuals in clinical trials, patient engagement (published 19-Mar-2025)
Read Article on RAPS.org

DIA Europe: Expert says risk pyramid can determine whether a device requires AI Act conformity assessment (published 20-Mar-2025)
Read Article on RAPS.org

Experts warn against decoupling safety and effectiveness from FDA approval (published 21-Mar-2025)
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Stakeholders ask FDA to consolidate accelerated approval guidances, clarify trial assessments (published 24-Mar-2025)
Read Article on RAPS.org

DIA Europe: Variations regulation expected to ease postapproval changes for pharmaceuticals (published 24-Mar-2025)
Read Article on RAPS.org

Dexcom cited for cGMP violations (published 25-Mar-2025)
Read Article on RAPS.org

Experts: Commonality exists in international AI regulation, but collaboration requires new approaches (published 25-Mar-2025)
Read Article on RAPS.org

Senate confirms Makary and Bhattacharya to lead FDA, NIH (published 26-Mar-2025)
Read Article on RAPS.org

Industry officials: Varied global postapproval change requirement pose challenges for drugmakers (published 27-Mar-2025)
Read Article on RAPS.org

FDA finds data integrity problems in recent warning letters (published 28-Mar-2025)
Read Article on RAPS.org

Marks resigns, blames Kennedy for spreading ‘misinformation and lies’ (published 31-Mar-2025)
Read Article on RAPS.org

• Review the recording from our webinar: Align New Oncology Drug Development with FDA's Project FrontRunner
• Learn how Veristat experts can help you better plan your decentralized clinical trials: Adopting Decentralized Clinical Trials
• Read our infographic to learn more about the different types of meetings under BsUFA FDA Meeting Types for Biosimilar Products
• Download the Infographic explaining the Types of FDA Meetings with CDER and CBER