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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:
Technical Specifications for Submitting Clinical Trial Data Sets for Response Assessments for Treatments of Acute Leukemias (published 14-Oct-2025)
Download FDA Guidance
Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers (published 22-Oct-2025)
Download FDA Guidance
Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments (published 23-Oct-2025)
Download FDA Guidance
FDA Draft Guidance:
Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies (published 29-Oct-2025)
Draft FDA Guidance
Monthly FDA Approvals
Approval Date: 10/02/2025
Drug Name: EYDENZELTBLA #761377
Active Ingredients: AFLIBERCEPT-BOAV
Submission Classification*:
Review Priority**:
Company: CELLTRION INC
Approval Date: 10/07/2025
Drug Name: LASIX ONYUNDA #217294
Active Ingredients: FUROSEMIDE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: SQ INNOVATION
Approval Date: 10/07/2025
Drug Name: JASCAYDNDA #218764
Active Ingredients: NERANDOMILAST
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: BOEHRINGER INGELHEIM
Approval Date: 10/16/2025
Drug Name: FERABRIGHTNDA #219868
Active Ingredients: FERUMOXYTOL
Submission Classification*: Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated
Review Priority**: Standard
Company: COVIS
Approval Date: 10/17/2025
Drug Name: EPIOXA HD/EPIOXA KITNDA #219910
Active Ingredients: RIBOFLAVIN 5'-PHOSPHATE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: GLAUKOS
Approval Date: 10/22/2025
Drug Name: CONTEPONDA #212271
Active Ingredients: FOSFOMYCIN
Submission Classification*: Type 2 - New Active Ingredient
Review Priority**: Priority
Company: MEITHEAL
Approval Date: 10/23/2025
Drug Name: DEHYDRATED ALCOHOLNDA #214988
Active Ingredients: DEHYDRATED ALCOHOL
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: ROYAL PHARMA LLC
Approval Date: 10/23/2025
Drug Name: JAVADINNDA #220256
Active Ingredients: CLONIDINE HYDROCHLORIDE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: AZURITY
Approval Date: 10/23/2025
Drug Name: BLENREPBLA #761440
Active Ingredients: BELANTAMAB MAFODOTIN-BLMF
Submission Classification*:
Review Priority**:
Company: GLAXOSMITHKLINE LLC
Approval Date: 10/24/2025
Drug Name: ROCURONIUM BROMIDENDA #219108
Active Ingredients: ROCURONIUM BROMIDE
Submission Classification*:
Review Priority**: Standard
Company: STERINOVA INC
Approval Date: 10/24/2025
Drug Name: LYNKUETNDA #219469
Active Ingredients: ELINZANETANT
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: BAYER HEALTHCARE PHARMS
Approval Date: 10/24/2025
Drug Name: RESNIBENNDA #220258
Active Ingredients: CABOZANTINIB
Submission Classification*:
Review Priority**: Standard
Company: AZURITY
Upcoming Advisory Board Meetings
N/A
Shutdown: FDA will not accept submissions requiring fees until funding resumes (published 01-Oct-2025)
Read Article on RAPS.org
Convergence 2025: Adapting to change and uncertainty in the regulatory landscape (published 06-Oct-2025)
Read Article on RAPS.org
FDA warns US firms over inadequate testing, lax process controls (published 07-Oct-2025)
Read Article on RAPS.org
Experts: AI can enhance clinical trial participant selection (published 07-Oct-2025)
Read Article on RAPS.org
Convergence: Rebuilding public trust in science with empathy, transparency (published 07-Oct-2025)
Read Article on RAPS.org
Convergence: ‘Get ready’ to use genAI in drug development (published 08-Oct-2025)
Read Article on RAPS.org
Convergence: Experts look for greater international alignment on combination products (published 13-Oct-2025)
Read Article on RAPS.org
Convergence: FDA, industry experts lead way on patient experience data (published 14-Oct-2025)
Read Article on RAPS.org
Convergence: New ICH Q1 guideline is ‘one-stop shop’ for stability testing (published 20-Oct-2025)
Read Article on RAPS.org
EMA partners with Instagram influencers to counter GLP-1 misinformation (published 21-Oct-2025)
Read Article on RAPS.org
FDA warns US and Australian eye drop companies for GMP violations, making unapproved claims (published 21-Oct-2025)
Read Article on RAPS.org
FDA’s drug and biologics centers report steep drop in headcount in FY 2025 (published 22-Oct-2025)
Read Article on RAPS.org
Stakeholders ask for flexibility, more examples in FDA guidance on overall survival in cancer trials (published 22-Oct-2025)
Read Article on RAPS.org
FDA publishes NDA filing checklist to avoid application derailments (23-Oct-2025)
Read Article on RAPS.org
FDA official issues warning about looming biosimilar void (28-Oct-2025)
Read Article on RAPS.org
FDA proposes to cut comparative efficacy study requirements for most biosimilars (29-Oct-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.