Monthly FDA Guidance and Regulatory News Review-September 2024

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:

Bioresearch Monitoring Technical Conformance Guide (published 03-Sep-2024)
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Control of Nitrosamine Impurities in Human Drugs (published 05-Sep-2024)
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Withdrawn Guidances (Biologics) (published 06-Sep-2024)
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Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry (published 13-Sep-2024)
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Study Data Technical Conformance Guide - Technical Specifications Document (published 16-Sep-2024)
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Data Standards Catalog (published 16-Sep-2024)
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Conducting Clinical Trials With Decentralized Elements (published 18-Sep-2024)
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An Acceptable Circular of Information for the Use of Human Blood and Blood Components (published 25-Sep-2024)
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FDA Draft Guidance:

Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs (published 16-Sep-2024)
Draft FDA Guidance

Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice (published 18-Sep-2024)
Draft FDA Guidance

Chemical Analysis for Biocompatibility Assessment of Medical Devices (published 20-Sep-2024)
Draft FDA Guidance

Monthly FDA Approvals

Approval Date: 09/12/2024
Drug Name: TECENTRIQ HYBREZABLA #761347
Active Ingredients: ATEZOLIZUMAB AND HYALURONIDASE-TQJS
Submission Classification*:
Review Priority**:
Company: GENENTECH INC

Approval Date: 09/13/2024
Drug Name: EBGLYSSBLA #761306
Active Ingredients: LEBRIKIZUMAB-LBKZ
Submission Classification*:
Review Priority**:
Company: ELI LILLY AND CO

Approval Date: 09/13/2024
Drug Name: OCREVUS ZUNOVOBLA #761371
Active Ingredients: OCRELIZUMAB AND HYALURONIDASE-OCSQ
Submission Classification*:
Review Priority**:
Company: GENENTECH INC

Approval Date: 09/20/2024
Drug Name: MIPLYFFANDA #214927
Active Ingredients: ARIMOCLOMOL CITRATE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: ZEVRA DENMARK

Approval Date: 09/24/2024
Drug Name: AQNEURSANDA #219132
Active Ingredients: LEVACETYLLEUCINE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: INTRABIO INC

Approval Date: 09/26/2024
Drug Name: COBENFYNDA #216158
Active Ingredients: XANOMELINE TARTRATE;TROSPIUM CHLORIDE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: BRISTOL-MYERS SQUIBB

Approval Date: 09/27/2024
Drug Name: BYNFEZIANDA #213224
Active Ingredients: OCTREOTIDE ACETATE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: SUN PHARM INDS INC

Approval Date: 09/27/2024
Drug Name: FLYRCADONDA #215168
Active Ingredients: FLURPIRIDAZ F 18
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: GE HEALTHCARE

Approval Date: 09/27/2024
Drug Name: OTULFIBLA #761379
Active Ingredients: USTEKINUMAB-AAUZ
Submission Classification*:
Review Priority**:
Company: FRESENIUS KABI USA

Upcoming Advisory Board Meetings

10/10/2024 Cardiovascular and Renal Drugs Advisory Committee Meeting- 08:15 AM EDT to 5:30 PM EDT

10/29/2024 Pharmacy Compounding Advisory Committee Meeting - 08:00 AM EDT to 05:00 PM EDT

11/19/2024 Joint Meeting of the Drug Safety and Risk Management Advisory Committee and Psychopharmacologic Drugs Advisory Committee Meeting - 08:30 AM EDT to 04:30 PM EDT

11/21/2024 Cellular, Tissue, and Gene Therapies Advisory Committee Meeting - 10:00 AM EDT to 04:00 PM EDT

Stakeholders ask for more details in FDA’s IT, customer service strategies (published 03-Sep-2024)
Read Article on RAPS.org

Study: Breakthrough therapies approved based on surrogate endpoints often lack post marketing requirements (published 04-Sep-2024)
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FDA revises final guidance on nitrosamine impurities (published 04-Sep-2024)
Read Article on RAPS.org

WHO issues guideline to curb antibiotic pollution (published 05-Sep-2024)
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FDA updates patient preference guidance to span the product life cycle (published 05-Sep-2024)
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FDA official clarifies cGMP expectations for investigational drugs (published 06-Sep-2024)
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Researchers tout the benefits of pragmatic clinical trials (published 06-Sep-2024)
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EMA updates guideline on developing drugs for bipolar disorder (published 09-Sep-2024)
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EMA, HMA publish large language model principles for regulators (published 09-Sep-2024)
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Pharma, device groups ask for more leeway to address misinformation (published 10-Sep-2024)
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Industry groups call for changes to FDA’s guidance on use-related risk analyses (published 10-Sep-2024)
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FDA seeks input on its innovative manufacturing technology strategy (published 12-Sep-2024)
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Integrated assessments: FDA consults on its integrated review documentation (published 12-Sep-2024)
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FDA drafts guidance on multiregional clinical trials in oncology (published 16-Sep-2024)
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Study: Oncology accelerated approvals are often based on non-comparative trials evaluating response rate (published 16-Sep-2024)
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FDA’s final guidance on DCTs adds clarity on HCP task log, inspection requirements, data variability (published 17-Sep-2024)
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Studies find uneven uptake of biosimilars as availability increases (published 18-Sep-2024)
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EU officials discuss advice pathways, return to office at Convergence (published 18-Sep-2024)
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FDA draft guidance paves way for more real-world, point-of-care clinical trials (published 19-Sep-2024)
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Industry concerned over hurdles in FDA’s biosimilars manufacturing changes guidance (published 25-Sep-2024)
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FDA official discusses agency’s new Rare Disease Innovation Hub (published 26-Sep-2024)
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EMA adopts reflection paper on AI/ML in drug development (published 30-Sep-2024)
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Califf calls for mandatory reporting of device shortages (published 30-Sep-2024)
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