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BIOSpain 2025
Meet Veristat at BIOSpain, October 7 - 9, 2025
Veristat is excited to attend BIOSpain 2025, one of Europe’s largest...
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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:
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions (published 18-Aug-2025)
Download FDA Guidance
Withdrawn Guidances (Biologics) (published 27-Aug-2025)
Download FDA Guidance
FDA Draft Guidance:
Approaches to Assessment of Overall Survival in Oncology Clinical Trials (published 18-Aug-2025)
Draft FDA Guidance
Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development (published 19-Aug-2025)
Draft FDA Guidance
Monthly FDA Approvals
Approval Date: 08/01/2025
Drug Name: E-Z-DISKNDA #219840
Active Ingredients: BARIUM SULFATE
Submission Classification*: Type 7 - Drug Already Marketed without Approved NDA
Review Priority**: Standard
Company: BRACCO
Approval Date: 08/06/2025
Drug Name: MODEYSONDA #219876
Active Ingredients: DORDAVIPRONE HYDROCHLORIDE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: CHIMERIX
Approval Date: 08/08/2025
Drug Name: HERNEXEOSNDA #219042
Active Ingredients: ZONGERTINIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: BOEHRINGER INGELHEIM
Approval Date: 08/08/2025
Drug Name: KYXATANDA #219921
Active Ingredients: CARBOPLATIN
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: AVYXA HOLDINGS
Approval Date: 08/12/2025
Drug Name: BRINSUPRINDA #217673
Active Ingredients: BRENSOCATIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: INSMED INC
Approval Date: 08/15/2025
Drug Name: CYKLXNDA #218643
Active Ingredients: ARTICAINE HYDROCHLORIDE
Submission Classification*: Type 3 - New Dosage Form and Type 4 - New Combination
Review Priority**: Standard
Company: AM GENOMICS
Approval Date: 08/15/2025
Drug Name: TONMYANDA #219428
Active Ingredients: CYCLOBENZAPRINE HYDROCHLORIDE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: TONIX
Approval Date: 08/21/2025
Drug Name: DAWNZERA (AUTOINJECTOR)NDA #219407
Active Ingredients: DONIDALORSEN SODIUM
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: IONIS PHARMS INC
Approval Date: 08/25/2025
Drug Name: CAMCEVI ETMNDA #219745
Active Ingredients: LEUPROLIDE MESYLATE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: FORESEE PHARMS
Approval Date: 08/28/2025
Drug Name: LOPRESSORNDA #218698
Active Ingredients: METOPROLOL TARTRATE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: XTM CONSULTING
Approval Date: 08/29/2025
Drug Name: OTEZLANDA #210745
Active Ingredients: APREMILAST
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: AMGEN INC
Approval Date: 08/29/2025
Drug Name: OTEZLA XRNDA #210745
Active Ingredients: APREMILAST
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: AMGEN INC
Approval Date: 08/29/2025
Drug Name: ESCITALOPRAMNDA #219130
Active Ingredients: ESCITALOPRAM OXALATE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: ALMATICA
Approval Date: 08/29/2025
Drug Name: WAYRILZNDA #219685
Active Ingredients: RILZABRUTINIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: GENZYME CORP
Approval Date: 08/29/2025
Drug Name: LEQEMBI IQLIKBLA #761375
Active Ingredients: LECANEMAB-IRMB
Submission Classification*:
Review Priority**:
Company: EISAI INC
Approval Date: 08/29/2025
Drug Name: BILDYOSBLA #761444
Active Ingredients: DENOSUMAB-NXXP
Submission Classification*:
Review Priority**:
Company: SHANGHAI HENLIUS BIOTECH
Approval Date: 08/29/2025
Drug Name: BILPREVDABLA #761444
Active Ingredients: DENOSUMAB-NXXP
Submission Classification*:
Review Priority**:
Company: SHANGHAI HENLIUS BIOTECH
Upcoming Advisory Board Meetings
N/A
Pharma groups suggest changes to FDA’s guidance on replacing color additives (published 04-Aug-2025)
Read Article on RAPS.org
MDUFA VI: FDA eyes growth while industry seeks refinement (published 04-Aug-2025)
Read Article on RAPS.org
FDA issues warning letters for CGMP violations, marketing devices for unintended uses (published 05-Aug-2025)
Read Article on RAPS.org
Industry asks for clarification, consistency in FDA’s 510(k) transfer guidance (published 06-Aug-2025)
Read Article on RAPS.org
EMA proposes updating guideline for Alzheimer's disease treatments (published 06-Aug-2025)
Read Article on RAPS.org
European Commission: Lack of alternatives to TiO2 precludes ban in drugs (published 07-Aug-2025)
Read Article on RAPS.org
ICH releases Q3E guideline on controlling extractables and leachables in drugs (published 07-Aug-2025)
Read Article on RAPS.org
Stakeholders at odds over FDA’s draft guidance on hernia mesh labeling (published 11-Aug-2025)
Read Article on RAPS.org
FDA’s drug quality report notes ‘significant’ uptick in inspections since pandemic (published 11-Aug-2025)
Read Article on RAPS.org
FDA warns Spectra Therapy for GMP violations, marketing unapproved device (published 12-Aug-2025)
Read Article on RAPS.org
FDA seeks feedback on ways to bring manufacturing back to the US (published 15-Aug-2025)
Read Article on RAPS.org
FDA proposes guidance on using overall survival endpoints in cancer drug trials (published 18-Aug-2025)
Read Article on RAPS.org
Majority of pharmaceutical plants located in disaster-prone areas, study shows (published 22-Aug-2025)
Read Article on RAPS.org
Expert recommends alternative approaches to substitute for randomized trials for COVID vaccines (published 25-Aug-2025)
Read Article on RAPS.org
FDA finalizes guidance on using animal studies to develop dental bone grafting devices (published 25-Aug-2025)
Read Article on RAPS.org
FDA’s CDER announces updated guidance agenda for 2025 (published 25-Aug-2025)
Read Article on RAPS.org
Industry wants clarity on scope of ICH stability testing guideline, timing of studies (published 26-Aug-2025)
Read Article on RAPS.org
FDA warns companies for GLP, CGMP, and marketing violations (published 26-Aug-2025)
Read Article on RAPS.org
FDA approves updated COVID vaccines with restrictions on their use (published 27-Aug-2025)
Read Article on RAPS.org
FDA officials explain how to ensure registries generate fit-for-purpose data (published 28-Aug-2025)
Read Article on RAPS.org
Experts call for more guidance from FDA on registries in oncology (published 29-Aug-2025)
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.