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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)
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Experts: Cuts at FDA could jeopardize US standing in clinical research, product innovation (published 03-Mar-2025)
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FDA warns Indian firm over cleanliness and poor record keeping, US drugmaker over investigation failures (published 04-Mar-2025)
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DOGE claims $30M savings from canceling 30 FDA leases (published 04-Mar-2025)
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USP publishes list of vulnerable medicines susceptible to shortages (published 05-Mar-2025)
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FDA’s St. Louis drug testing lab to remain open despite DOGE claim (published 05-Mar-2025)
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Experts propose restricting trademarks on accelerated approval drugs to speed confirmatory trials (published 07-Mar-2025)
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FDA reviewers, inspectors, and investigators excluded from $25K buyout offer (published 10-Mar-2025)
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EMA spells out data access policy for shortage monitoring platform (published 10-Mar-2025)
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FDA admonishes Chinese device testing lab for falsified studies, copied data (published 11-Mar-2025)
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Stakeholders want FDA to address alternatives, sample retention in biopsy guidance (published 11-Mar-2025)
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Stakeholders: FDA should align pulse oximeter guidance with updated ISO standard (published 12-Mar-2025)
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FDA makes flu vaccine recommendations after canceled VRBPAC, closed-door meeting (published 13-Mar-2025)
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Experts: Strong design controls are key to FDA device approval (published 13-Mar-2025)
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Experts recommend being tactful, concise, and evidentiary when submitting guidance comments (published 14-Mar-2025)
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Study: FDA offers flexibility, expedited review to first-in-class drugs more often than EMA (published 17-Mar-2025)
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FDA’s return-to-office chaos, probationary workers reinstated, and demotion fears (published 17-Mar-2025)
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Study: Nearly one-third of device adverse event reports were late or missing data (published 18-Mar-2025)
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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)
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DIA Europe: Expert says risk pyramid can determine whether a device requires AI Act conformity assessment (published 20-Mar-2025)
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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)
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DIA Europe: Variations regulation expected to ease postapproval changes for pharmaceuticals (published 24-Mar-2025)
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Dexcom cited for cGMP violations (published 25-Mar-2025)
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Experts: Commonality exists in international AI regulation, but collaboration requires new approaches (published 25-Mar-2025)
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Senate confirms Makary and Bhattacharya to lead FDA, NIH (published 26-Mar-2025)
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Industry officials: Varied global postapproval change requirement pose challenges for drugmakers (published 27-Mar-2025)
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FDA finds data integrity problems in recent warning letters (published 28-Mar-2025)
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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
Taylor Mulkerin
Associate Project Manager, Regulatory Affairs
Taylor Mulkerin is an Associate Project Manager of Regulatory Affairs at Veristat. Taylor brings extensive experience supporting regulatory projects across a broad spectrum of therapeutic areas, including rare diseases, infectious diseases, neurology, cardiovascular, diabetes, oncology, atopic dermatitis, gastroenterology, and CNTF.
His expertise spans the full regulatory lifecycle—from preclinical and Phase 1–3 development through to NDA and BLA submissions, approvals, and post-approval activities. Taylor has provided project management support for key regulatory milestones such as Orphan Drug Designation (ODD), pre-IND and IND submissions, Drug Master Files (DMF), and End-of-Phase 2 (EOP2) meetings.
At Veristat, Taylor contributes to the company's impressive track record of supporting 160+ marketing applications and achieving 80+ regulatory approvals, helping sponsors navigate the complexities of drug development and regulatory submission processes.
His expertise spans the full regulatory lifecycle—from preclinical and Phase 1–3 development through to NDA and BLA submissions, approvals, and post-approval activities. Taylor has provided project management support for key regulatory milestones such as Orphan Drug Designation (ODD), pre-IND and IND submissions, Drug Master Files (DMF), and End-of-Phase 2 (EOP2) meetings.
At Veristat, Taylor contributes to the company's impressive track record of supporting 160+ marketing applications and achieving 80+ regulatory approvals, helping sponsors navigate the complexities of drug development and regulatory submission processes.