Monthly FDA Guidance and Regulatory News Review - April 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

Providing Regulatory Submissions in Electronic Format: IND Safety Reports Guidance for Industry (published 01-Apr-2024)
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Study Data Technical Conformance Guide - Technical Specifications Document (published 01-Apr-2024)
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Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry (published 01-Apr-2024)
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Data Standards Catalog (published 16-Apr-2024)
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Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels (published 30-Apr-2024)
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FDA Draft Guidance:

Data Integrity for In Vivo Bioavailability and Bioequivalence Studies (published 03-Apr-2024)
Draft FDA Guidance

Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry (published 24-Apr-2024)
Draft FDA Guidance

Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications (published 25-Apr-2024)
Draft FDA Guidance

Cancer Clinical Trial Eligibility Criteria: Performance Status (published 25-Apr-2024)
Draft FDA Guidance

Monthly FDA Approvals

Approval Date: 04/03/2024
Drug Name: ZEVTERANDA #218275
Active Ingredients: CEFTOBIPROLE MEDOCARIL SODIUM
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: BASILEA PHARM ALLSCH

Approval Date: 04/04/2024
Drug Name: XROMINDA #216593
Active Ingredients: HYDROXYUREA
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Priority
Company: NOVA LABS LTD

Approval Date: 04/10/2024
Drug Name: RETEVMONDA #218160
Active Ingredients: SELPERCATINIB
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: LOXO ONCOL ELI LILLY

Approval Date: 04/12/2024
Drug Name: ENTRESTONDA #218591
Active Ingredients: SACUBITRIL;VALSARTAN
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: NOVARTIS

Approval Date: 04/12/2024
Drug Name: ENTRESTO SPRINKLENDA #218591
Active Ingredients: SACUBITRIL; VALSARTAN
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: NOVARTIS

Approval Date: 04/12/2024
Drug Name: ENTRESTO SPRINKLENDA #218591
Active Ingredients: SACUBITRIL;VALSARTAN
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard

Company: NOVARTIS

Approval Date: 04/16/2024
Drug Name: SELARSDIBLA #761343
Active Ingredients: USTEKINUMAB-AEKN
Submission Classification*:
Review Priority**:
Company: ALVOTECH USA INC

Approval Date: 04/17/2024
Drug Name: LUMISIGHTNDA #214511
Active Ingredients: PEGULICIANINE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: LUMICELL

Approval Date: 04/17/2024
Drug Name: LUMISIGHTNDA #214511
Active Ingredients: PEGULICIANINE ACETATE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: LUMICELL

Approval Date: 04/18/2024
Drug Name: ENTYVIOBLA #761359
Active Ingredients: VEDOLIZUMAB
Submission Classification*:
Review Priority**:
Company: TAKEDA PHARMS USA

Approval Date: 04/19/2024
Drug Name: REZENOPYNDA #215487
Active Ingredients: NALOXONE HYDROCHLORIDE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: SUMMIT BIOSCI

Approval Date: 04/19/2024
Drug Name: LUMIFY PRESERVATIVE FREENDA #218424
Active Ingredients: BRIMONIDINE TARTRATE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: BAUSCH AND LOMB INC

Approval Date: 04/22/2024
Drug Name: ANKTIVABLA #761336
Active Ingredients: nogapendekin alfa inbakicept-pmln
Submission Classification*:
Review Priority**:
Company: ALTOR BIOSCIENCE, LLC, AN INDIRECT WHOLLY-OWNED SU

Approval Date: 04/23/2024
Drug Name: OJEMDANDA #217700
Active Ingredients: TOVORAFENIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: DAY ONE BIOPHARMACEUTICALS INC

Approval Date: 04/23/2024
Drug Name: OJEMDANDA #218033
Active Ingredients: TOVORAFENIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: DAY ONE BIOPHARMACEUTICALS INC

Approval Date: 04/24/2024
Drug Name: PIVYANDA #216483
Active Ingredients: AMDINOCILLIN PIVOXIL
Submission Classification*: Type 2 - New Active Ingredient
Review Priority**: Priority
Company: UTILITY THERAPEUTICS LTD

Approval Date: 04/24/2024
Drug Name: VIJOICENDA #218466
Active Ingredients: ALPELISIB
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: NOVARTIS PHARMS CORP

Approval Date: 04/25/2024
Drug Name: HERCESSIBLA #761346
Active Ingredients: TRASTUZUMAB-STRF
Submission Classification*:
Review Priority**:
Company: ACCORD BIOPHARMA INC.

Approval Date: 04/26/2024
Drug Name: RINVOQNDA #218347
Active Ingredients: UPADACITINIB
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: ABBVIE INC

Approval Date: 04/26/2024
Drug Name: RINVOQ LQNDA #218347
Active Ingredients: UPADACITINIB
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: ABBVIE INC

Approval Date: 04/26/2024
Drug Name: LIBERVANTNDA #218623
Active Ingredients: DIAZEPAM
Submission Classification*: Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval
Review Priority**: Standard
Company: AQUESTIVE THERAPEUTICS INC

Approval Date: 04/26/2024
Drug Name: XOLREMDINDA #218709
Active Ingredients: MAVORIXAFOR
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: X4 PHARMACEUTICALS INC

Approval Date: 04/30/2024
Drug Name: VASOPRESSINNDA #217766
Active Ingredients: VASOPRESSIN
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: LONG GROVE PHARMS

Approval Date: 04/30/2024
Drug Name: INGREZZA SPRINKLENDA #218390
Active Ingredients: VALBENAZINE
Submission Classification*:
Review Priority**: Standard
Company: NEUROCRINE

Upcoming Advisory Board Meetings

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

05/24/2024- Endocrinologic and Metabolic Drugs Advisory Committee Meeting- 9:00 AM EDT to 4:00 PM EDT

Industry wants to avoid surprises in remote regulatory assessments (published 01-Apr-2024)
Read Article on RAPS.org

FDA reprimands test makers over improper severity ratings, marketing unauthorized diagnostic (published 03-Apr-2024)
Read Article on RAPS.org

Study: Few FDA-approved targeted cancer drugs meet ESMO benefit benchmarks (published 04-Apr-2024)
Read Article on RAPS.org

FDA biostatistician recommends transparency, early conversation with reviewers (published 04-Apr-2024)
Read Article on RAPS.org

EMA says it will consider conditional approval for NASH drugs using intermediate endpoints (published 05-Apr-2024)
Read Article on RAPS.org

Study: Accelerated approvals leave lingering uncertainty about cancer drugs’ benefits (published 08-Apr-2024)
Read Article on RAPS.org

FDA statistician offers tips for evaluating wearables for clinical trials (published 09-Apr-2024)
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Drug shortages: Study examines pandemic supply chain, HHS proposes resilience incentive (published 09-Apr-2024)
Read Article on RAPS.org

European Parliament adopts pharmaceutical reform package (published 11-Apr-2024)
Read Article on RAPS.org

FDA launches new clinical trial center to improve innovation, communication (published 15-Apr-2024)
Read Article on RAPS.org

FDA officials say FY 2025 budget increase needed to offset inflationary pay increases (published 16-Apr-2024)
Read Article on RAPS.org

ICH M13A BE testing guideline expected to be adopted this summer (published 17-Apr-2024)
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Regulators explain process for requesting real-world evidence studies by EMA (published 18-Apr-2024)
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WHO issues guidance on nitrosamine controls in drug manufacturing (published 19-Apr-2024)
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Study: Many non-oncologic surrogate markers lack meta-analyses linking them to outcomes (published 22-Apr-2024)
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Industry advises practical fixes for new FDA guidance on data monitoring committees (published 23-Apr-2024)
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EMA group calls for multi-prong measures to tackle shortages (published 23-Apr-2024)
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CBER chief on remote work, CRISPR-Cas9, and rare disease gene therapy accelerated approval guidance (published 24-Apr-2024)
Read Article on RAPS.org

FDA provides update on status of postmarketing reports and commitments (published 25-Apr-2024)
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FDA updates guidance on promotional labeling and advertising of biosimilars (published 26-Apr-2024)
Read Article on RAPS.org

FDA issues three guidances to expand cancer clinical trial eligibility (published 29-Apr-2024)
Read Article on RAPS.org

FDA drafts two guidances on safety testing for cell and gene therapy products
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