Monthly FDA Guidance and Regulatory News Review - November 2025

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FDA Draft Guidance: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.