Monthly FDA Guidance and Regulatory News Review - December 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:

Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions (published 03-Dec-2024)
Download FDA Guidance

Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions Guidance for Industry (published 06-Dec-2024)
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Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH) (published 13-Dec-2024)
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E11A Pediatric Extrapolation (published 30-Dec-2024)
Download FDA Guidance

Advanced Manufacturing Technologies Designation Program (published 31-Dec-2024)
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FDA Draft Guidance:

Accelerated Approval – Expedited Program for Serious Conditions (published 05-Dec-2024)
Draft FDA Guidance

Combined Food and Drug Administration and Sponsor Oncologic Drugs Advisory Committee Briefing Document (published 27-Dec-2024)
Draft FDA Guidance

Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices (published 30-Dec-2024)
Draft FDA Guidance

M15 General Principles for Model-Informed Drug Development (published 30-Dec-2024)
Draft FDA Guidance

E6(R3) Good Clinical Practice: Annex 2 (published 30-Dec-2024)
Draft FDA Guidance

Monthly FDA Approvals

Approval Date: 12/04/2024
Drug Name: BIZENGRIBLA #761352
Active Ingredients: ZENOCUTUZUMAB-ZBCO
Submission Classification*:
Review Priority**:
Company: MERUS N.V.

Approval Date: 12/12/2024
Drug Name: ONTRALFYNDA #216190
Active Ingredients: TIZANIDINE HYDROCHLORIDE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: FIDELITY BIOPHARMA

Approval Date: 12/13/2024
Drug Name: CRENESSITYNDA #218808
Active Ingredients: CRINECERFONT
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: NEUROCRINE

Approval Date: 12/13/2024
Drug Name: CRENESSITYNDA #218820
Active Ingredients: CRINECERFONT
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: NEUROCRINE

Approval Date: 12/13/2024
Drug Name: UNLOXCYTBLA #761297
Active Ingredients: COSIBELIMAB-IPDL
Submission Classification*:
Review Priority**:
Company: CHECKPOINT THERAPEUTICS INC

Approval Date: 12/13/2024
Drug Name: NEMLUVIOBLA #761391
Active Ingredients: NEMOLIZUMAB-ILTO
Submission Classification*:
Review Priority**:
Company: GALDERMA LABS LP

Approval Date: 12/17/2024
Drug Name: STEQEYMABLA #761338
Active Ingredients: USTEKINUMAB-STBA
Submission Classification*:
Review Priority**:
Company: CELLTRION, INC.

Approval Date: 12/18/2024
Drug Name: ENSACOVENDA #218171
Active Ingredients: ENSARTINIB HYDROCHLORIDE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: XCOVERY

Approval Date: 12/19/2024
Drug Name: TRYNGOLZA (AUTOINJECTOR)NDA #218614
Active Ingredients: OLEZARSEN SODIUM
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: IONIS PHARMS INC

Approval Date: 12/20/2024
Drug Name: ALYFTREKNDA #218730
Active Ingredients: DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: VERTEX PHARMS INC

Approval Date: 12/20/2024
Drug Name: ALHEMOBLA #761315
Active Ingredients: CONCIZUMAB-MTCI
Submission Classification*:
Review Priority**:
Company: NOVO NORDISK INC

Approval Date: 12/26/2024
Drug Name: TEVIMBRABLA #761417
Active Ingredients: TISLELIZUMAB-JSGR
Submission Classification*:
Review Priority**:
Company: BEIGENE

Approval Date: 12/27/2024
Drug Name: OPDIVO QVANTIGBLA #761381
Active Ingredients: NIVOLUMAB;HYALURONIDASE-NVHY
Submission Classification*:
Review Priority**:
Company: BRISTOL-MYERS SQUIBB

Approval Date: 12/27/2024
Drug Name: OPDIVO QVANTIGBLA #761429
Active Ingredients: NIVOLUMAB;HYALURONIDASE-NVHY
Submission Classification*:
Review Priority**:
Company: BRISTOL-MYERS SQUIBB

Upcoming Advisory Board Meetings

1/10/2025 Anesthetic and Analgesic Drug Products Advisory Committee Meeting- 09:00 AM EDT to 04:30 PM EDT

2/05/2025 Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Meeting- 08:00 AM EDT to 05:00 PM EDT

2/24/2025 Cardiovascular and Renal Drugs Advisory Committee Meeting- 09:00 AM EDT to 05:00 PM EDT

FDA issues reports on best practices for communication, guidance development (published 02-Dec-2024)
Read Article on RAPS.org

Final FDA guidance on PCCP includes clarification on version control (published 03-Dec-2024)
Read Article on RAPS.org

Accelerated approval: FDA revises guidance to reflect revised withdrawal procedures (published 05-Dec-2024)
Read Article on RAPS.org

FDA finalizes BIMO electronic submission guidance (published 09-Dec-2024)
Read Article on RAPS.org

EMA issues guidelines on shortage mitigation, prevention plans (published 09-Dec-2024)
Read Article on RAPS.org

Researchers suggest FDA needs authority to require pediatric studies for orphan drugs (published 10-Dec-2024)
Read Article on RAPS.org

FDA establishes new center to streamline new drug development using RWD/RWE (published 13-Dec-2024)
Read Article on RAPS.org

EMA, HMA overhaul guidance on data transparency in MAAs (published 18-Dec-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