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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:
No FDA final guidance for the month of May
FDA Draft Guidance:
Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (published 02-May-2025)
Draft FDA Guidance
Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (published 02-May-2025)
Draft FDA Guidance
Replacing Color Additives in Approved or Marketed Drug Products (published 29-May-2025)
Draft FDA Guidance
M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver (published 30-May-2025)
Draft FDA Guidance
Monthly FDA Approvals
Approval Date: 5/08/2025
Drug Name: AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)NDA #219616
Active Ingredients: AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: VERASTEM INC
Approval Date: 5/14/2025
Drug Name: BREKIYA (AUTOINJECTOR)NDA #215400
Active Ingredients: DIHYDROERGOTAMINE MESYLATE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: AMNEAL
Approval Date: 5/14/2025
Drug Name: EMRELISBLA #761384
Active Ingredients: TELISOTUZUMAB VEDOTIN-TLLV
Submission Classification*:
Review Priority**:
Company: ABBVIE INC
Approval Date: 5/20/2025
Drug Name: AUSUSVARNDA #217062
Active Ingredients: RIVAROXABAN
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: AUSON PHARM
Approval Date: 5/22/2025
Drug Name: STARJEMZABLA #761419
Active Ingredients: ustekinumab-hmny
Submission Classification*:
Review Priority**:
Company: BIO-THERA SOLUTIONS LTD
Approval Date: 5/23/2025
Drug Name: YUTREPIANDA #213005
Active Ingredients: TREPROSTINIL
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: Liquidia Technologies, Inc.
Approval Date: 5/28/2025
Drug Name: TRYPTYRNDA #217370
Active Ingredients: ACOLTREMON
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: ALCON LABS INC
Approval Date: 5/28/2025
Drug Name: KHINDIVNDA #218980
Active Ingredients: HYDROCORTISONE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: ETON
Senate appropriators decry deep potential cuts to NIH budget (published 01-May-2025)
Read Article on RAPS.org
Experts: Maintain inspection readiness despite recent upheaval at FDA (published 05-May-2025)
Read Article on RAPS.org
EU regulators issue workplan for optimizing AI and big data (published 07-May-2025)
Read Article on RAPS.org
FDA plans to roll out AI agency-wide for reviews in June (published 08-May-2025)
Read Article on RAPS.org
EMA proposes to incorporate Annex 1 in GMP guide for ATMPs (published 09-May-2025)
Read Article on RAPS.org
International group proposes best practices for AI in pharmacovigilance (published 12-May-2025)
Read Article on RAPS.org
FDA warns foreign drugmakers over mold, filthy facilities, and other GMP issues (published 14-May-2025)
Read Article on RAPS.org
FDA deputy commissioner hints at potential changes to PDUFA (published 19-May-2025)
Read Article on RAPS.org
FDA unveils new COVID-19 framework, restricting shots to elderly and high-risk people (published 20-May-2025)
Read Article on RAPS.org
ICH announces new topics, draft guidelines for consultation (published 21-May-2025)
Read Article on RAPS.org
FDA proposes FY 2026 budget; Makary offers details on staff attrition (published 22-May-2025)
Read Article on RAPS.org
FDA warning letters flag GMP violations, false advertising of drugs (published 23-May-2025)
Read Article on RAPS.org
FDA hands drugmaker, diagnostics firm warning letters for GMP violations (published 28-May-2025)
Read Article on RAPS.org
ICH releases guidelines on developing medicines for pregnant population and quality information in CTD (published 28-May-2025)
Read Article on RAPS.org
Industry wants clarity on decentralized trials and informed consent in ICH GCP annex (published 29-May-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.