Monthly FDA Guidance and Regulatory News Review - March 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. Below are the relevant links to updates provided for both COVID-19 related and non-COVID-19 related programs in March 2024.

FDA Final Guidance

Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry (published 01-Mar-2024)
Download FDA Guidance

Q2(R2) Validation of Analytical Procedures (published 06-Mar-2024)
Download FDA Guidance

Q14 Analytical Procedure Development (published 07-Mar-2024)
Download FDA Guidance

Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing (published 15-Mar-2024)
Download FDA Guidance

Controlled Correspondence Related to Generic Drug Development (published 18-Mar-2024)
Download FDA Guidance

Study Data Technical Conformance Guide - Technical Specifications Document (published 29-Mar-2024)
Download FDA Guidance

FDA Draft Guidance:

Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards (published 01-Mar-2024)
Draft FDA Guidance

Early Alzheimer’s Disease: Developing Drugs for Treatment (12-Mar-2024)
Draft FDA Guidance

Use of Data Monitoring Committees in Clinical Trials (13-Feb-2024)
Draft FDA Guidance

E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports (13-Mar-2024)
Draft FDA Guidance

Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products (13-Mar-2024)
Draft FDA Guidance

Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products (21-Mar-2024)
Draft FDA Guidance

Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples (27-Mar-2024)
Draft FDA Guidance

Monthly FDA Approvals

Approval Date: 02/29/2024
Drug Name: LETYBOBLA #761225
Active Ingredients: LETIBOTULINUMTOXINA-WLBG
Submission Classification*:
Review Priority**:
Company: HUGEL INC

Approval Date: 03/04/2024
Drug Name: CLOBETASOL PROPIONATENDA #218158
Active Ingredients: CLOBETASOL PROPIONATE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: FORMOSA

Approval Date: 03/05/2024
Drug Name: TYENNEBLA #761275
Active Ingredients: TOCILIZUMAB-AAZG
Submission Classification*:
Review Priority**:
Company: FRESENIUS KABI USA

Approval Date: 03/05/2024
Drug Name: JUBBONTIBLA #761362
Active Ingredients: DENOSUMAB-BBDZ
Submission Classification*:
Review Priority**:
Company: SANDOZ INC

Approval Date: 03/05/2024
Drug Name: WYOSTBLA #761362
Active Ingredients: DENOSUMAB-BBDZ
Submission Classification*:
Review Priority**:
Company: SANDOZ INC

Approval Date: 03/07/2024
Drug Name: TALZENNANDA #217439
Active Ingredients: TALAZOPARIB TOSYLATE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: PFIZER

Approval Date: 03/13/2024
Drug Name: TEVIMBRABLA #761232
Active Ingredients: TISLELIZUMAB-JSGR
Submission Classification*:
Review Priority**:
Company: BEIGENE

Approval Date: 03/14/2024
Drug Name: CABAZITAXELNDA #207970
Active Ingredients: CABAZITAXEL
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: ACTAVIS

Approval Date: 03/14/2024
Drug Name: CABAZITAXEL INJECTIONNDA #207970
Active Ingredients: CABAZITAXEL
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: ACTAVIS

Approval Date: 03/14/2024
Drug Name: REZDIFFRANDA #217785
Active Ingredients: RESMETIROM
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: MADRIGAL

Approval Date: 03/15/2024
Drug Name: EDURANT PEDNDA #219016
Active Ingredients: RILPIVIRINE HYDROCHLORIDE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Priority
Company: JANSSEN PRODS

Approval Date: 03/19/2024
Drug Name: TRYVIONDA #217686
Active Ingredients: APROCITENTAN
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: IDORSIA PHARMA LTD

Approval Date: 03/21/2024
Drug Name: DUVYZATNDA #217865
Active Ingredients: GIVINOSTAT HYDROCHLORIDE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: ITALFARMACO SA

Approval Date: 03/22/2024
Drug Name: EFAVIRENZ, EMTRICITABINE AND TENOFOVIR ALAFENAMIDENDA #213509
Active Ingredients: EFAVIRENZ, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
Submission Classification*: Type 4 - New Combination
Review Priority**: Standard
Company: MYLAN

Approval Date: 03/22/2024
Drug Name: OPSYNVINDA #218490
Active Ingredients: MACITENTAN; TADALAFIL
Submission Classification*: Type 4 - New Combination
Review Priority**: Standard
Company: ACTELION

Approval Date: 03/26/2024
Drug Name: WINREVAIRBLA #761363
Active Ingredients: SOTATERCEPT-CSRK
Submission Classification*:
Review Priority**:
Company: MERCK SHARP DOHME

Approval Date: 03/27/2024
Drug Name: VAFSEONDA #215192
Active Ingredients: VADADUSTAT
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: AKEBIA THERAPEUTICS INC

Approval Date: 03/29/2024
Drug Name: RISVANNDA #214835
Active Ingredients: RISPERIDONE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: LABORATORIOS FARMACEUTICOS ROVI SA

Upcoming Advisory Board Meetings

04/12/2024- Oncologic Drugs Committee Meeting- 09:00 AM EDT to 4:00 PM EDT

05/09/2024- Blood Products Advisory Committee Meeting- 9:30 AM EDT to 3:10 PM EDT

05/16/2024- Vaccines and Related Biological Products Advisory Committee Meeting- 8:30 AM EDT to 4:30 PM EDT

05/22/2024- Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting- 10:00 AM EDT to 3:45 PM EDT

FDA recommends participants receive key trial information early, concisely (published 04-Mar-2024)
Read Article on RAPS.org

UK’s MHRA approves first drug under international recognition procedure (published 05-Mar-2024)
Read Article on RAPS.org

European Commission proposes framework for joint clinical assessments (published 07-Mar-2024)
Read Article on RAPS.org

Industry advises FDA not to issue more guidances without public comment (published 07-Mar-2024)
Read Article on RAPS.org

European Commission proposes framework for joint clinical assessments (published 07-Mar-2024)
Read Article on RAPS.org

FDA updates early Alzheimer’s drug development guidance to add support for biomarkers, surrogate endpoints (published 11-Mar-2024)
Read Article on RAPS.org

FDA wants $7.2B for product safety, public health in Biden’s FY 2025 budget (published 12-Mar-2024)
Read Article on RAPS.org

European Commission finalizes plan to streamline variation process (published 13-Mar-2024)
Read Article on RAPS.org

EU regulators and industry clash on pharmaceutical reform package (published 13-Mar-2024)
Read Article on RAPS.org

Bumpus discusses adcomms, animal testing, and AI (published 13-Mar-2024)
Read Article on RAPS.org

Experts discuss regulatory approaches for AI and current industry practices (published 14-Mar-2024)
Read Article on RAPS.org

FDA proposes rule for difficult-to-compound drugs, drug categories (published 20-Mar-2024)
Read Article on RAPS.org

How Sumatha Kondabolu learned quality assurance and how RAPS membership helps her (published 20-Mar-2024)
Read Article on RAPS.org

Industry clamors for clarity on FDA’s advanced manufacturing designation program (published 21-Mar-2024)
Read Article on RAPS.org

FDA offers guidance on observational studies as RWE (published 21-Mar-2024)
Read Article on RAPS.org

Regulators cite need to involve diverse patient groups in decision-making (published 22-Mar-2024)
Read Article on RAPS.org

EMA revises draft guideline on data to support clinical trials for ATMPs (published 25-Mar-2024)
Read Article on RAPS.org

Stakeholders seek to reshape FDA’s guidance for master protocols (published 26-Mar-2024)
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