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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:
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act (published 06-Jan-2025)
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Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act (published 06-Jan-2025)
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Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers (published 06-Jan-2025)
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Evaluation of Sex Differences in Clinical Investigations (published 20-Jan-2025)
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Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (published 31-Jan-2025)
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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 31-Jan-2025)
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FDA Draft Guidance:
Recommendations to Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (published 06-Jan-2025)
Draft FDA Guidance
Recommendations to Reduce the Risk of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (published 06-Jan-2025)
Draft FDA Guidance
Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (published 06-Jan-2025)
Draft FDA Guidance
Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (published 06-Jan-2025)
Draft FDA Guidance
Considerations for Complying with 21 CFR 211.110 (published 06-Jan-2025)
Draft FDA Guidance
Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products (published 06-Jan-2025)
Draft FDA Guidance
Considerations for Including Tissue Biopsies in Clinical Trials (published 07-Jan-2025)
Draft FDA Guidance
Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway (published 07-Jan-2025)
Draft FDA Guidance
Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy: Developing Drug and Biological Products in Oncology (published 17-Jan-2025)
Draft FDA Guidance
Monthly FDA Approvals
Approval Date: 01/16/2025
Drug Name: BRYNOVINNDA #219122
Active Ingredients: SITAGLIPTIN HYDROCHLORIDE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: AZURITY
Approval Date: 01/17/2025
Drug Name: DATROWAYBLA #761394
Active Ingredients: DATOPOTAMAB DERUXTECAN-DLNK
Submission Classification*:
Review Priority**:
Company: DAIICHI SANKYO INC
Approval Date: 01/21/2025
Drug Name: GRAFAPEXNDA #214759
Active Ingredients: TREOSULFAN
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: MGFKSMB
Approval Date: 01/24/2025
Drug Name: AVTOZMABLA #761420
Active Ingredients: TOCILIZUMAB-ANOH
Submission Classification*:
Review Priority**:
Company: CELLTRION INC
Approval Date: 01/28/2025
Drug Name: INZIRQONDA #219141
Active Ingredients: HYDROCHLOROTHIAZIDE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: NOVITIUM PHARMA
Approval Date: 01/30/2025
Drug Name: SYMBRAVONDA #215431
Active Ingredients: MELOXICAM || RIZATRIPTAN BENZOATE
Submission Classification*: Type 4 - New Combination
Review Priority**: Standard
Company: AXSOME
Approval Date: 01/30/2025
Drug Name: JOURNAVXNDA #219209
Active Ingredients: SUZETRIGINE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: VERTEX PHARMS
FDA issues draft guidance on developing and managing AI-enabled devices (published 06-Jan-2025)
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Batch uniformity: FDA details testing approaches for continuous manufacturing, 3D printing (published 06-Jan-2025)
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AI in drug development: FDA draft guidance addresses product lifecycle, risk (published 07-Jan-2025)
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FDA proposes update to 18-year guidance on developing weight loss drugs (published 07-Jan-2025)
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FDA finalizes advanced manufacturing technology designation guidance (published 07-Jan-2025)
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FDA finalizes guidance on off-label communications (published 08-Jan-2025)
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Pulse Oximeters: FDA drafts guidance to address performance disparities (published 08-Jan-2025)
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CDER approved 50 novel drugs in 2024, record number of biosimilars (published 09-Jan-2025)
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FDA proposes uniform system for classifying protocol deviations (published 09-Jan-2025)
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FDA warns Canadian firm for hostile behavior during inspection, two Indian facilities for GMP issues (published 10-Jan-2025)
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Accelerated approval: FDA explains when it considers confirmatory trials underway (published 10-Jan-2025)
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FDA finalizes guidance on reporting medical device shortages (published 13-Jan-2025)
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FDA proposes to modernize guidance on sex, gender in clinical trials (published 14-Jan-2025)
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Hologic warned over recalled BioZorb implants (published 14-Jan-2025)
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ICH adopts E6(R3) guideline on good clinical practices (published 14-Jan-2025)
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FDA warns five device makers for Quality System, CAPA issues (published 15-Jan-2025)
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FDA officials clarify how diversity action plans intersect with multiregional clinical trials (published 15-Jan-2025)
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WHO outlines best practices for continuous manufacturing (published 16-Jan-2025)
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FDA draft guidance outlines appropriate use of tissue biopsies in clinical trials (published 20-Jan-2025)
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WHO guideline aims to facilitate the development of more durable pediatric medicines (published 20-Jan-2025)
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Sanofi issued warning letter for Genzyme cGMP failures (published 21-Jan-2025)
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Incell warned for marketing unapproved product, CGMP violations (published 22-Jan-2025)
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CDER announces new guidance agenda for 2025 (published 23-Jan-2025)
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Health agencies recommend best practices for using surrogate endpoints (published 24-Jan-2025)
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Stakeholders disagree over FDA’s regulatory approach to generative AI (published 27-Jan-2025)
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Stakeholders ask FDA to harmonize oligonucleotide-based therapeutics guidances (published 28-Jan-2025)
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Study finds variation in evidence for FDA approval of novel psychiatric drugs (published 31-Jan-2025)
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FDA’s recent warning letters target BIMO violations, unapproved products (published 31-Jan-2025)
Read Article on RAPS.org
- Review the recording from our webinar: Align New Oncology Drug Development with FDA's Project FrontRunner
- Learn how Veristat experts can help you better plan your decentralized clinical trials: Adopting Decentralized Clinical Trials
- Read our infographic to learn more about the different types of meetings under BsUFA FDA Meeting Types for Biosimilar Products
- Download the Infographic explaining the Types of FDA Meetings with CDER and CBER
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.