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November brought significant FDA activity, with new final and draft guidances—from Pre-RFD updates to cross-center master files and Q3E leachables—alongside notable RAPS coverage, leadership changes, regulatory developments, and multiple high-impact drug approvals. Together, these updates offer Veristat clients a clearer view of what may shape upcoming regulatory decisions and interactions.
FDA Final Guidance:
How to Prepare a Pre-Request for Designation (Pre-RFD) (published 06-Nov-2025)
Download FDA Guidance
FDA Draft Guidance:
Cross-Center Master Files: Where to Submit (published 25-Nov-2025)
Draft FDA Guidance
Q3E Guideline for Extractables and Leachables: Supporting Documentation: Class 3 Leachable Monographs (published 28-Nov-2025)
Draft FDA Guidance
Q3E Guideline for Extractables and Leachables (published 28-Nov-2025)
Draft FDA Guidance
Medical Gases — Current Good Manufacturing Practice (published 28-Nov-2025)
Draft FDA Guidance
Monthly FDA Approvals
Approval Date: 11/03/2025
Drug Name: KYGEVVINDA #219792
Active Ingredients: DOXECITINE; DOXRIBTIMINE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: UCB INC
Approval Date: 11/13/2025
Drug Name: KOMZIFTINDA #220305
Active Ingredients: ZIFTOMENIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: KURA
Approval Date: 11/13/2025
Drug Name: POHERDYBLA #761450
Active Ingredients: PERTUZUMAB-DPZB
Submission Classification*:
Review Priority**:
Company: SHANGHAI HENLIUS BIOTECH
Approval Date: 11/18/2025
Drug Name: REDEMPLONDA #219947
Active Ingredients: PLOZASIRAN SODIUM
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: ARROWHEAD
Approval Date: 11/19/2025
Drug Name: HYRNUONDA #219972
Active Ingredients: SEVABERTINIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: BAYER HEALTHCARE
Approval Date: 11/21/2025
Drug Name: RuxolitinibNDA #219660
Active Ingredients: Ruxolitinib
Submission Classification*: Type 2 - New Active Ingredient
Review Priority**: Standard
Company: APOTEX
Approval Date: 11/25/2025
Drug Name: VOYXACTBLA #761434
Active Ingredients: SIBEPRENLIMAB-SZSI
Submission Classification*:
Review Priority**:
Company: OTSUKA PHARM CO LTD
Approval Date: 11/28/2025
Drug Name: ARMLUPEGBLA #761212
Active Ingredients: PEGFILGRASTIM-UNNE
Submission Classification*:
Review Priority**:
Company: LUPIN LTD
Upcoming Advisory Board Meetings
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FDA updates Pre-RFD guidance with new recommendations (published 07-Nov-2025)
Read Article on RAPS.org
FDA to remove boxed warnings from hormone therapies for menopause (published 10-Nov-2025)
Read Article on RAPS.org
Expert: AI compliance in EU requires proactive lifecycle management approach (published 10-Nov-2025)
Read Article on RAPS.org
FDA questions on genAI-enabled chatbots raise concerns from expert panel (published 10-Nov-2025)
Read Article on RAPS.org
Pazdur takes helm at CDER after Tidmarsh departure (published 11-Nov-2025)
Read Article on RAPS.org
FDA issues slew of warning letters for GMP and unapproved drug violations (published 12-Nov-2025)
Read Article on RAPS.org
FDA leaders propose new ‘plausible mechanism’ pathway for bespoke medicines (published 13-Nov-2025)
Read Article on RAPS.org
This week at the FDA: New CDER director, end of the shutdown, and more (published 14-Nov-2025)
Read Article on RAPS.org
Read CRLs, review documents for human factors insights, experts say (published 14-Nov-2025)
Read Article on RAPS.org
FDA finalizes guidance on criteria for granting waiver requests for pH adjusters (published 17-Nov-2025)
Read Article on RAPS.org
FDA finalizes guidance on patient-focused drug development (published 18-Nov-2025)
Read Article on RAPS.org
Stakeholders weigh in on FDA’s draft clinical outcome assessment template (published 20-Nov-2025)
Read Article on RAPS.org
Gastroenterology group asks FDA for more discussion on GERD guidances (published 25-Nov-2025)
Read Article on RAPS.org
Commenters ask FDA to allow rare disease classification for disseminated coccidioidomycosis drugs (25-Nov-2025)
Read Article on RAPS.org
FDA guidance outlines where to send “cross-center” master files (25-Nov-2025)
Read Article on RAPS.org
ICH announces new topics, adopts harmonized template for clinical trial protocols (26-Nov-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.