Monthly FDA Guidance and Regulatory News Review - November 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:

Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Guidance for Industry; Availability (published 27-Nov-2024)
Download FDA Guidance

FDA Draft Guidance:

Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics (published 15-Nov-2024)
Draft FDA Guidance

Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products (published 21-Nov-2024)
Draft FDA Guidance

Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic Products (published 27-Nov-2024)
Draft FDA Guidance

Recommended Follow up Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical Trials With Healthy Subjects (published 27-Nov-2024)
Draft FDA Guidance

Monthly FDA Approvals

Approval Date: 11/01/2024
Drug Name: EMROSINDA #219015
Active Ingredients: MINOCYCLINE HYDROCHLORIDE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: DR REDDYS

Approval Date: 11/07/2024
Drug Name: DANZITENNDA #219293
Active Ingredients: NILOTINIB TARTRATE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: AZURITY

Approval Date: 11/15/2024
Drug Name: REVUFORJNDA #218944
Active Ingredients: REVUMENIB CITRATE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: SYNDAX

Approval Date: 11/20/2024
Drug Name: ZIIHERABLA #761416
Active Ingredients: ZANIDATAMAB-HRII
Submission Classification*:
Review Priority**:
Company: JAZZ PHARMS

Approval Date: 11/21/2024
Drug Name: DAPTOMYCINNDA #217630
Active Ingredients: DAPTOMYCIN
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: MAIA PHARMS INC

Approval Date: 11/22/2024
Drug Name: ATTRUBYNDA #216540
Active Ingredients: ACORAMIDIS
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: BRIDGEBIO PHARMA INC

Approval Date: 11/22/2024
Drug Name: RAPIBLYKNDA #217202
Active Ingredients: LANDIOLOL
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: AOP ORPHAN PHARMACEUTICALS GMBH

Approval Date: 11/22/2024
Drug Name: IMKELDINDA #219097
Active Ingredients: IMATINIB
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: SHORLA

Approval Date: 11/26/2024
Drug Name: RALDESYNDA #218637
Active Ingredients: TRAZODONE HYDROCHLORIDE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: KAMAT PHARMATECH, LLC

Approval Date: 11/27/2024
Drug Name: IOMERVUNDA #216016
Active Ingredients: IOMEPROL
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: BRACCO DIAGNOSTICS INC

Approval Date: 11/27/2024
Drug Name: IOMERVUNDA #216017
Active Ingredients: IOMEPROL
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: BRACCO DIAGNOSTICS INC

Approval Date: 11/29/2024
Drug Name: YESINTEKBLA #761406
Active Ingredients: USTEKINUMAB-KFCE
Submission Classification*:
Review Priority**:
Company: BIOCON BIOLOGICS INC

Upcoming Advisory Board Meetings

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

Drug shortages more common in the US than Canada, study finds (published 01-Nov-2024)
Read Article on RAPS.org

FDA revises more than 800 PSGs in line with ICH M13A (published 01-Nov-2024)
Read Article on RAPS.org

Recent CBER warning letters target unapproved products, BIMO violations (published 04-Nov-2024)
Read Article on RAPS.org

Stakeholders want more collaboration, regulatory flexibility in FDA’s new rare disease hub (published 04-Nov-2024)
Read Article on RAPS.org

Stakeholders want more opportunities to discuss MIDD with FDA (published 05-Nov-2024)
Read Article on RAPS.org

FDA to test STAR pilot for original applications (published 05-Nov-2024)
Read Article on RAPS.org

Industry groups spar over FDA’s proposed compounding survey (published 06-Nov-2024)
Read Article on RAPS.org

USP: India and China continue their API manufacturing reign (published 08-Nov-2024)
Read Article on RAPS.org

FDA proposes guidance for nonclinical safety assessment of oligonucleotide-based drugs (published 13-Nov-2024)
Read Article on RAPS.org

ICH touts significant milestones reached this year in adopting and advancing guidelines (published 14-Nov-2024)
Read Article on RAPS.org

FDA again urges lawmakers for new notification authority, funding to address future pandemics (published 14-Nov-2024)
Read Article on RAPS.org

Study finds ‘substantial revenues’ for cancer drugs in granted pediatric exclusivity (published 15-Nov-2024)
Read Article on RAPS.org

EMA proposes research on challenging regulatory topics, new research platform (published 18-Nov-2024)
Read Article on RAPS.org

ICH releases draft GCP annex, MIDD guideline (published 18-Nov-2024)
Read Article on RAPS.org

FDA drafts Q&A guidance on cell and gene therapy development (published 19-Nov-2024)
Read Article on RAPS.org

Stakeholders seek changes to FDA’s oncology multiregional trial guideline (published 20-Nov-2024)
Read Article on RAPS.org

FDA warns Chinese drugmaker for refusing access during inspection, Indian firm for data integrity lapses (published 20-Nov-2024)
Read Article on RAPS.org

ICH exploring global platform for reviewing post approval CMC changes (published 26-Nov-2024)
Read Article on RAPS.org

FDA recommends collecting ovarian toxicity data in cancer drug trials (published 26-Nov-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