Regulatory Guidance Monthly Review - October 2023

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. Below are the relevant links to updates provided for both COVID-19 related and non-COVID-19 related programs in October 2023.

FDA Final Guidance

Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding” (published 02-Oct-2023)
Download FDA Guidance

Investigational COVID-19 Convalescent Plasma (published 13-Oct-2023)
Download FDA Guidance

Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol (published 17-Oct-2023)
Download FDA Guidance

Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements (published 17-Oct-2023)
Download FDA Guidance

Benefit-Risk Assessment for New Drug and Biological Products (published 20-Oct-2023)
Download FDA Guidance

FDA Draft Guidance:

Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities (published 26-Oct-2023)
Draft FDA Guidance

Monthly FDA Approvals

Approval Date: 10/6/2023
Drug Name: COSENTYXBLA #761349
Active Ingredients: SECUKINUMAB
Submission Classification*:
Review Priority**:
Company: NOVARTIS PHARMS CORP

Approval Date: 10/12/2023
Drug Name: DOLUTEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDENDA #213681
Active Ingredients: DOLUTEGRAVIR;EMTRICITABINE;TENOFOVIR ALAFENAMIDE
Submission Classification*: Type 4 - New Combination
Review Priority**: Standard
Company: LAURUS LABS LTD

Approval Date: 10/12/2023
Drug Name: VELSIPITYNDA #216956
Active Ingredients: ETRASIMOD ARGININE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: PFIZER INC

Approval Date: 10/17/2023
Drug Name: XPHOZAHNDA #213931
Active Ingredients: TENAPANOR HYDROCHLORIDE
Submission Classification*: Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated
Review Priority**: Standard
Company: ARDELYX INC

Approval Date: 10/17/2023
Drug Name: COMBOGESIC IVNDA #215320
Active Ingredients: ACETAMINOPHEN AND IBUPROFEN
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: AFT PHARMS LTD

Approval Date: 10/17/2023
Drug Name: ZILBRYSQNDA #216834
Active Ingredients: ZILUCOPLAN SODIUM
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: UCB INC

Approval Date: 10/17/2023
Drug Name: QLOSINDA #217836
Active Ingredients: PILOCARPINE HYDROCHLORIDE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: ORASIS PHARMACEUTICALS, LTD.

Approval Date: 10/17/2023
Drug Name: BIMZELXBLA #761151
Active Ingredients: BIMEKIZUMAB-BKZX
Submission Classification*:
Review Priority**:
Company: UCB INC

Approval Date: 10/18/2023
Drug Name: ZITUVIONDA #211566
Active Ingredients: SITAGLIPTIN
Submission Classification*: Type 2 - New Active Ingredient
Review Priority**: Standard
Company: ZYDUS WORLDWIDE DMCC

Approval Date: 10/20/2023
Drug Name: CABTREONDA #216632
Active Ingredients: CLINDAMYCIN PHOSPHATE, ADAPALENE, AND BENZOYL PEROXIDE
Submission Classification*: Type 4 - New Combination
Review Priority**: Standard
Company: BAUSCH HEALTH US, LLC

Approval Date: 10/20/2023
Drug Name: COXANTONDA #217927
Active Ingredients: OXAPROZIN
Submission Classification*:
Review Priority**: Standard
Company: SOLUBIOMIX, LLC

Approval Date: 10/20/2023
Drug Name: ROZLYTREKNDA #218550
Active Ingredients: ENTRECTINIB
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Priority
Company: GENENTECH INC

Approval Date: 10/20/2023
Drug Name: ZYMFENTRABLA #761358
Active Ingredients: INFLIXIMAB-DYYB
Submission Classification*:
Review Priority**:
Company: CELLTRION

Approval Date: 10/26/2023
Drug Name: AGAMREENDA #215239
Active Ingredients: VAMOROLONE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: SANTHERA PHARMA

Approval Date: 10/26/2023
Drug Name: OMVOHBLA #761279
Active Ingredients: MIRIKIZUMAB-MRKZ
Submission Classification*:
Review Priority**:
Company: ELI LILLY AND CO

Approval Date: 10/27/2023
Drug Name: CABAZITAXELNDA #208715
Active Ingredients: CABAZITAXEL
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: SANDOZ

Approval Date: 10/27/2023
Drug Name: LOQTORZIBLA #761240
Active Ingredients: TORIPALIMAB-TPZI
Submission Classification*:
Review Priority**:
Company: COHERUS BIOSCIENCES INC

Approval Date: 10/31/2023
Drug Name: WEZLANABLA #761285
Active Ingredients: USTEKINUMAB-AUUB
Submission Classification*:
Review Priority**:
Company: AMGEN INC

Approval Date: 10/31/2023
Drug Name: WEZLANABLA #761331
Active Ingredients: USTEKINUMAB-AUUB
Submission Classification*:
Review Priority**:
Company: AMGEN INC

Upcoming Advisory Board Meetings

11/16/2023- Meeting of the Oncologic Drugs Advisory Committee- 09:00 AM EDT to 01:30 PM EDT

11/17/2023- Meeting of Pulmonary- Allergy Drugs Advisory Committee- 09:00 AM EDT- 05:00 PM EDT

Convergence: Change and collaboration are the future of the regulatory profession (published 03-Oct-2023)
Read Article on RAPS.org

FDA finalizes guidance on dose banding for injectables (published 03-Oct-2023)
Read Article on RAPS.org

FDA guidance explores trial design, supporting data for GVHD treatments (published 03-Oct-2023)
Read Article on RAPS.org

Convergence: Psychedelic drug development is ‘hot,’ but proceed with caution (published 04-Oct-2023)
Read Article on RAPS.org

Convergence: CBER chief discusses priorities, touts gene therapy approvals (published 05-Oct-2023)
Read Article on RAPS.org

FDA offers first guidance on stimulant use disorder drug development (published 06-Oct-2023)
Read Article on RAPS.org

Reimbursement, AI top list of priorities for new digital health lobbying group (published 09-Oct-2023)
Read Article on RAPS.org

Diversity plan draft guidance on track before year-end, FDA official says (published 10-Oct-2023)
Read Article on RAPS.org

Convergence: Confusion lingers over interchangeability and switching of biosimilars (published 10-Oct-2023)
Read Article on RAPS.org

Convergence: Expert calls for data governance structure for collection of real-world data (published 12-Oct-2023)
Read Article on RAPS.org

FDA officials stress natural history studies in supporting rare disease drug development (published 19-Oct-2023)
Read Article on RAPS.org

ICH releases Q9 training materials on quality risk management (published 19-Oct-2023)
Read Article on RAPS.org

FDA finalizes guidance on considerations for evaluating drug’s benefits and risks (published 20-Oct-2023)
Read Article on RAPS.org

FDA addresses use of remote interactive evaluations in post-pandemic era (published 25-Oct-2023)
Read Article on RAPS.org

Biosimilars: FDA offers rationale for dropping interchangeability designations (published 30-Oct-2023)
Read Article on RAPS.org

FDA expands KASA review program to drug substances (published 31-Oct-2023)
Read Article on RAPS.org

• Review the recording from our webinar: Future Trends on Europeans Regulations on Medicines
• 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