Monthly FDA Guidance and Regulatory News Review - June 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:

Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics: Guidance for Industry (published 14-Jun-2024)
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Diabetic Foot Infections: Developing Drugs for Treatment (published 17-Jun-2024)
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Facility Readiness: Goal Date Decisions Under GDUFA (published 18-Jun-2024)
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Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection: Guidance for Industry (published 20-Jun-2024)
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FDA Draft Guidance:

Processes and Practices Applicable to Bioresearch Monitoring Inspections: Draft Guidance for Industry (published 05-Jun-2024)
Draft FDA Guidance

Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center of Biologics Evaluation and Research Submissions (published 05-Jun-2024)
Draft FDA Guidance

Considerations in Demonstrating Interchangeability With a Reference Product: Update (published 21-Jun-2024)
Draft FDA Guidance

Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies: Draft Guidance for Industry (published 26-Jun-2024)
Draft FDA Guidance

Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products: Draft Guidance for Industry (published 28-Jun-2024)
Draft FDA Guidance

Monthly FDA Approvals

Approval Date: 06/04/2024
Drug Name: TERIPARATIDENDA #218771
Active Ingredients: TERIPARATIDE
Submission Classification: Type 5 - New Formulation or New Manufacturer
Review Priority: Standard
Company: ALMAJECT

Approval Date: 06/06/2024
Drug Name: RYTELONDA #217779
Active Ingredients: IMETELSTAT SODIUM
Submission Classification: Type 1 - New Molecular Entity
Review Priority: Standard
Company: GERON

Approval Date: 06/10/2024
Drug Name: IQIRVONDA #218860
Active Ingredients: ELAFIBRANOR
Submission Classification: Type 1 - New Molecular Entity
Review Priority: Priority
Company: IPSEN

Approval Date: 06/17/2024
Drug Name: VIGAFYDENDA #217684
Active Ingredients: VIGABATRIN
Submission Classification:
Review Priority: Standard
Company: PYROS PHARMS

Approval Date: 06/18/2024
Drug Name: SOFDRANDA #217347
Active Ingredients: SOFPIRONIUM BROMIDE
Submission Classification: Type 1 - New Molecular Entity
Review Priority: Standard
Company: BOTANIX SB

Approval Date: 06/20/2024
Drug Name: PIASKYBLA #761388
Active Ingredients: CROVALIMAB-AKKZ
Submission Classification:
Review Priority:
Company: GENENTECH INC

Approval Date: 06/25/2024
Drug Name: TEPYLUTENDA #216984
Active Ingredients: THIOTEPA
Submission Classification: Type 3 - New Dosage Form
Review Priority: Standard
Company: SHORLA

Approval Date: 06/28/2024
Drug Name: PEMETREXEDNDA #210661
Active Ingredients: PEMETREXED
Submission Classification: Type 2 - New Active Ingredient
Review Priority: Standard
Company: APOTEX INC

Approval Date: 06/28/2024
Drug Name: CHEWTADZYNDA #218527
Active Ingredients: TADALAFIL
Submission Classification: Type 3 - New Dosage Form
Review Priority: Standard
Company: B BETTER LLC

Approval Date: 06/28/2024
Drug Name: NYPOZIBLA #761126
Active Ingredients: FILGRASTIM-TXID
Submission Classification:
Review Priority:
Company: TANVEX BIOPHARMA USA INC

Approval Date: 06/28/2024
Drug Name: PYZCHIVABLA #761373
Active Ingredients: USTEKINUMAB-TTWE
Submission Classification:
Review Priority:
Company: SAMSUNG BIOEPIS CO LTD

Approval Date: 06/28/2024
Drug Name: AHZANTIVEBLA #761378
Active Ingredients: AFLIBERCEPT
Submission Classification:
Review Priority:
Company: FORMYCON AG

Approval Date: 06/28/2024
Drug Name: PYZCHIVABLA #761425
Active Ingredients: USTEKINUMAB-TTWE
Submission Classification:
Review Priority:
Company: SAMSUNG BIOEPIS CO LTD

Upcoming Advisory Board Meetings

07/25/2024 - Oncologic Drugs Advisory Committee Meeting- 09:00 AM EDT to 02:15 PM EDT EDT

Experts, FDA officials discuss future of clinical trials (published 03-Jun-2024)
Read Article on RAPS.org

AAM seeks clarity, leeway in BA/BE studies guidance (published 03-Jun-2024)
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FDA official discusses best practice for requesting feedback for combination products (published 04-Jun-2024)
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FDA issues draft guidances covering BIMO inspections (published 05-Jun-2024)
Read Article on RAPS.org

FDA official offers compliance updates, discusses enforcement misperceptions (published 06-Jun-2024)
Read Article on RAPS.org

Industry experts peel back the curtain on user fee negotiations (published 07-Jun-2024)
Read Article on RAPS.org

Regulators launch two ACT EU advice pilots to promote clinical research in Europe (published 10-Jun-2024)
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Experts advise against prescriptive FDA policies for regulating AI (published 10-Jun-2024)
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ICH announces forthcoming documents on nitrosamine impurities, RWD (published 12-Jun-2024)
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MDCG aims to harmonize adverse events reports for surgical mesh in the EU (published 13-Jun-2024)
Read Article on RAPS.org

FDA, Health Canada, MHRA release guiding principles on transparency for machine learning medical devices (published 14-Jun-2024)
Read Article on RAPS.org

Study: Women underrepresented in clinical trials of medical devices (published 17-Jun-2024)
Read Article on RAPS.org

FDA finalizes guidance on drug development for diabetic foot infections (published 18-Jun-2024)
Read Article on RAPS.org

DIA: Pharma expert offers advice on AI best practices for industry (published 18-Jun-2024)
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DIA: Marks questions the need for new conditional approval pathway (published 20-Jun-2024)
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Stakeholders request elaboration, consistency in FDA’s non-interventional RWE studies guidance (published 20-Jun-2024)
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Industry officials report mixed experiences with recent FDA pilot programs (published 21-Jun-2024)
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FDA publishes LDT rule ‘CliffsNotes’ in guidance for small companies (published 24-Jun-2024)
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FDA official tells CGT developers to leverage multiple meeting opportunities with agency (published 24-Jun-2024)
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EMA official updates on EU clinical trial transparency rules (published 25-Jun-2024)
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FDA issues diversity action plan draft guidance (published 26-Jun-2024)
Read Article on RAPS.org

Stakeholders urge FDA to strengthen guidance on biosimilars promotions, stop bad actors (published 27-Jun-2024)
Read Article on RAPS.org

EMA officials discuss expedited approval pathways, scientific advice mechanisms
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