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Product Launch Readiness Zürich
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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FDA Draft Guidance: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)
Read Article on RAPS.org
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)
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- 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