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Meet Veristat at BIO-Europe Spring: March 23-25, 2026 - Lisbon, Portugal
🔬 Connecting with the Global Biopharma Community
Veristat is pleased to attend BIO-Europe Spring, where biotech...
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March 2026 regulatory updates underscore newly published final and draft guidances focused on real-world data, safety reporting, biosimilars, CGMP inspections, and innovative drug development methods. It also highlights industry news and regulatory trends, such as increased scrutiny on advertising, evolving biosimilar requirements, growing interest in AI and alternative methodologies, and ongoing user fee program negotiations. Additionally, it lists recent FDA drug approvals and notes an upcoming oncology advisory committee meeting, providing a snapshot of current regulatory developments and approvals.
FDA Final Guidance:
M14 General Principles on Planning, Designing, Analyzing, and Reporting of Non-interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines (published 04-Mar-2026)
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E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports (published 04-Mar-2026)
Download FDA Guidance
Questions and Answers on Biosimilar Development and the BPCI Act (published 08-Mar-2026)
Download FDA Guidance
FDA Draft Guidance:
Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection (published 09-Mar-2026)
Draft FDA Guidance
New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4) (published 09-Mar-2026)
Draft FDA Guidance
General Considerations for the Use of New Approach Methodologies in Drug Development (published 19-Mar-2026)
Draft FDA Guidance
Monthly FDA Approvals
Approval Date: 03/06/2026
Drug Name: PYLARIFY TRUVUNDA #220089
Active Ingredients: PIFLUFOLASTAT F-18
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: APHELION
Approval Date: 03/17/2026
Drug Name: ICOTYDENDA #220149
Active Ingredients: ICOTROKINRA HYDROCHLORIDE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: JANSSEN BIOTECH
Approval Date: 03/17/2026
Drug Name: LYNAVOYNDA #220295
Active Ingredients: LINERIXIBAT
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: GLAXOSMITHKLINE
Approval Date: 03/19/2026
Drug Name: FLAVALTANDA #216564
Active Ingredients: EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: DEPROCO
Approval Date: 03/19/2026
Drug Name: KITPROZYNDA #220712
Active Ingredients: CARFILZOMIB
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: AMNEAL PHARMS NY
Approval Date: 03/20/2026
Drug Name: ATONCYNDA #220320
Active Ingredients: ATOMOXETINE HYDROCHLORIDE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: MAP77
Approval Date: 03/24/2026
Drug Name: AVLAYAHBLA #761485
Active Ingredients: TIVIDENOFUSP ALFA-EKNM
Submission Classification*:
Review Priority**:
Company: DENALI THERAPEUTICS INC.
Approval Date: 03/25/2026
Drug Name: LIFYORLITMNDA #220641
Active Ingredients: RELACORILANT
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: CORCEPT THERAP
Approval Date: 03/30/2026
Drug Name: EPINEPHRINENDA #220626
Active Ingredients: EPINEPHRINE
Submission Classification*: New Combination and New Formulation or New Manufacturer
Review Priority**: Standard
Company: BAXTER HLTHCARE CORP
Upcoming Advisory Board Meetings
30-Apr-2026: Oncologic Drugs Advisory Committee Meeting- 08:00 AM EDT- 05:00 PM EDT
FDA seeks feedback on overhaul of its SUPAC guidelines (published 02-Mar-2026)
Read article on RAPS.org
Study: Patients may not understand evidentiary differences for conditionally approved drugs (published 03-Mar-2026)
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FDA official: Core inspectional functions, priorities unchanged despite leadership changes (published 03-Mar-2026)
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Experts recommend targeted internal communication for sharing regulatory intelligence (published 03-Mar-2026)
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FDA drafts guidance explaining 3-year clinical investigation exclusivity for new drugs (published 04-Mar-2026)
Read article on RAPS.org
FDA cites Novo Nordisk again for misleading GLP-1 ad (published 05-Mar-2026)
Read article on RAPS.org
FDA official offers insights on agency’s criteria for RWD in regulatory submissions (published 06-Mar-2026)
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FDA drafts guidance on best practices for responding to inspection observations (published 06-Mar-2026)
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FDA official details top GMP violations cited in inspection reports (published 09-Mar-2026)
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FDA proposes major change to biosimilar PK study requirements (published 09-Mar-2026)
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Novo Nordisk gets FDA warning letter for adverse event reporting violations (published 10-Mar-2026)
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Experts offer tips for using AI for drug advertising and promotion (published 10-Mar-2026)
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FDA consolidates adverse events reporting systems (published 11-Mar-2026)
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Expert: Stryker cyberattack could lead FDA to reassess cybersecurity requirements (published 13-Mar-2026)
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EMA proposes new paper on proof-of-concept studies for pediatric oncology drugs (published 13-Mar-2026)
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Experts propose new framework for overseeing genAI health tools (published 16-Mar-2026)
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PDUFA VIII: Negotiations touch on patient experience data, reserve funding, fee waivers, and more (published 16-Mar-2026)
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MDUFA VI: FDA, industry make headway in reauthorization negotiations (published 17-Mar-2026)
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FDA finalizes guidance on assessing bioequivalence of topical drugs (published 17-Mar-2026)
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Industry asks FDA to affirm Bayesian methods guidance applies broadly to drugs (18-Mar-2026)
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FDA drafts guidance on animal testing alternatives (18-Mar-2026)
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FDA warns four firms in India and Germany for GMP, BIMO violations (19-Mar-2026)
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Study: AI-enabled pediatric medical devices rare, limited to few clinical areas (20-Mar-2026)
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GDUFA IV: Negotiations address DMFs, internal consultations, imminent actions (24-Mar-2026)
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GAO calls on FDA to finalize guidance on adcomm COI (24-Mar-2026)
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Advocacy group calls for greater transparency at FDA (26-Mar-2026)
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Industry calls for synchronized implementation of ICH M4Q(R2) (26-Mar-2026)
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FDA issues warning letters for false advertising, CGMP violations, and more (26-Mar-2026)
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FDA finalizes guidance on patient preference information for devices (27-Mar-2026)
Read article on RAPS.org
- Article: FDA Delays Push Biotech Companies to Rethink U.S. Drug Development Strategy
- Webinar Presentation: Selecting the Right Oncology CRO Partner
- Blog: Bayesian Study Designs in Early-Phase Oncology Trials
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.