1 min read
SCOPE: Powering the Future of Clinical Research
Meet Veristat at SCOPE: Powering the Future of Clinical Research February 2-5, 2026
🔬 Advancing Clinical Research with...
3 min read
January 2026 regulatory updates underscored evolving AI-focused policies, ongoing scrutiny of evidentiary standards, strengthened compliance expectations, several product approvals, and advanced review modernization initiatives. The month also introduced three draft guidances that align closely with areas where Veristat has deep, practical experience. Collectively, these guidances reinforce a clear theme: regulators continue to encourage innovative statistical approaches, rigorous (eCTD) submissions, and well-constructed multiple myeloma clinical trials. Sponsors that integrate statistical innovation, therapeutic insight, and proactive regulatory planning early are better positioned to navigate this evolving landscape.
FDA Final Guidance:
Clinical Decision Support Software: Guidance for Industry and Food and Drug Administration Staff (published 29-Jan-2026)
Download FDA Guidance
FDA Draft Guidance:
Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products: Draft Guidance for Industry (published 09-Jan-2026)
Draft FDA Guidance
M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality (published 20-Jan-2026)
Draft FDA Guidance
Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval: Draft Guidance for Industry (published 21-Jan-2026)
Draft FDA Guidance
Monthly FDA Approvals
Approval Date: 01/12/2026
Drug Name: ZYCUBONDA #211241
Active Ingredients: COPPER HISTIDINATE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: SENTYNL THERAPS INC
Approval Date: 01/15/2026
Drug Name: FILKRIBLA #761027
Active Ingredients: FILGRASTIM-LAHA
Submission Classification*:
Review Priority**:
Company: ACCORD BIOPHARMA INC.
Approval Date: 01/21/2026
Drug Name: AVTOZMABLA #761498
Active Ingredients: TOCILIZUMAB-ANOH
Submission Classification*:
Review Priority**:
Company: CELLTRION INC
Approval Date: 01/26/2026
Drug Name: QUIOFICNDA #216395
Active Ingredients: FOLIC ACID
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: CMP DEV LLC
Approval Date: 01/28/2026
Drug Name: YUVEZZINDA #220142
Active Ingredients: BRIMONIDINE TARTRATE; CARBACHOL
Submission Classification*: Type 3 - New Dosage Form and Type 4 - New Combination
Review Priority**: Standard
Company: VISUS
Upcoming Advisory Board Meetings
12-Mar-2026: Vaccines and Related Biological Products Advisory Committee Meeting- 09:00 AM EDT- 3:30 PM EDT
Experts raise concerns over lower evidentiary standard for FDA’s leucovorin approval (published 12-Jan-2026)
Read Article on RAPS.org
FDA touts new flexible approach to reviewing cell and gene therapies (published 12-Jan-2026)
Read Article on RAPS.org
CBER outlines its guidance priorities for 2026 (published 12-Jan-2026)
Read Article on RAPS.org
FDA issues warning letters for GMP, GCP violations (published 13-Jan-2026)
Read Article on RAPS.org
CDER approved 46 novel drugs in 2025, half for rare diseases (published 13-Jan-2026)
Read Article on RAPS.org
EMA, FDA issue joint AI guiding principles for drug developers (published 14-Jan-2026)
Read Article on RAPS.org
FDA reports lack of interest, high rejection rate for its STAR program (published 15-Jan-2026)
Read Article on RAPS.org
EMA recommended 38 new drugs in 2025, fewer than prior year (published 16-Jan-2026)
Read Article on RAPS.org
EMA updates guideline on peripheral arterial occlusive disease drugs (published 16-Jan-2026)
Read Article on RAPS.org
Swissmedic reaches deal to make significant staffing cuts (published 19-Jan-2026)
Read Article on RAPS.org
CBER updates two guides for staff on reviewing INDs and handling clinical holds (published 20-Jan-2026)
Read Article on RAPS.org
FDA proposes guidance on endpoints for multiple myeloma therapeutics accelerated approval trials (published 20-Jan-2026)
Read Article on RAPS.org
FDA drafts guidance on cuffless blood pressure measuring devices (published 22-Jan-2026)
Read Article on RAPS.org
Industry spars over FDA plan to cut comparative efficacy studies for biosimilars (published 26-Jan-2026)
Read Article on RAPS.org
Industry wants more streamlining following recent EU reforms (published 27-Jan-2026)
Read Article on RAPS.org
FDA official offers tips on leveraging AI in drug manufacturing (published 27-Jan-2026)
Read Article on RAPS.org
Combined studies: Commission officials outline proposed reforms (published 28-Jan-2026)
Read Article on RAPS.org
EMA issues guidelines on quality, therapeutic equivalence of inhaled drugs (published 29-Jan-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.