Monthly FDA Guidance and Regulatory News Review - July 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:

Drugs for the Treatment of Partial Onset Seizures: Extrapolation of Efficacy from Adults to Pediatric Patients 1 Month of Age and Older (published 15-Jul-2024)
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Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy (published 17-Jul-2024)
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Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies (published 18-Jul-2024)
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Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma (published 21-Jul-2024)
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Container Closure System and Component Changes: Glass Vials and Stoppers (published 24-Jul-2024)
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Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products (published 25-Jul-2024)
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FDA Draft Guidance:

M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines (published 05-Jul-2024)
Draft FDA Guidance

Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products (published 08-Jul-2024)
Draft FDA Guidance

Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment (published 22-Jun-2024)
Draft FDA Guidance

Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers (published 23-Jul-2024)
Draft FDA Guidance

Monthly FDA Approvals

Approval Date: 07/02/2024
Drug Name: KISUNLABLA #761248
Active Ingredients: DONANEMAB-AZBT
Submission Classification*:
Review Priority**:
Company: ELI LILLY CO

Approval Date: 07/11/2024
Drug Name: VASOPRESSIN IN SODIUM CHLORIDE 0.9%NDA #217766
Active Ingredients: VASOPRESSIN
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: LONG GROVE PHARMS

Approval Date: 07/13/2024
Drug Name: MEDICAL AIR, USPNDA #219709
Active Ingredients: MEDICAL AIR
Submission Classification*:
Review Priority**: Unknown
Company: WSM SUPPLIER LLC

Approval Date: 07/17/2024
Drug Name: VOQUEZNANDA #218710
Active Ingredients: VONOPRAZAN FUMARATE
Submission Classification*: Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval
Review Priority**: Standard
Company: PHATHOM PHARMACEUTICALS INC

Approval Date: 07/18/2024
Drug Name: ZITUVIMET XRNDA #216778
Active Ingredients: METFORMIN HYDROCHLORIDE; SITAGLIPTIN
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: ZYDUS

Approval Date: 07/19/2024
Drug Name: EPYSQLIBLA #761340
Active Ingredients: ECULIZUMAB-AAGH
Submission Classification*:
Review Priority**:
Company: SAMSUNG BIOEPIS CO LTD

Approval Date: 07/22/2024
Drug Name: OPIPZANDA #216655
Active Ingredients: ARIPIPRAZOLE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: XIAMEN LP PHARM CO

Approval Date: 07/22/2024
Drug Name: FEMLYVNDA #218718
Active Ingredients: ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: MILLICENT PR

Approval Date: 07/25/2024
Drug Name: LEQSELVINDA #217900
Active Ingredients: DEURUXOLITINIB PHOSPHATE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: SUN PHARM INDS INC

Approval Date: 07/25/2024
Drug Name: APREPITANTNDA #218754
Active Ingredients: APREPITANT
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: AZURITY

Approval Date: 07/26/2024
Drug Name: ERZOFRINDA #216352
Active Ingredients: PALIPERIDONE PALMITATE
Submission Classification*: Type 5 - New Formulation or New Manufacturer

Review Priority**: Standard
Company: LUYE INNOMIND PHARMA

Approval Date: 07/26/2024
Drug Name: POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDENDA #218343
Active Ingredients: POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: AMNEAL

Approval Date: 07/26/2024
Drug Name: ZUNVEYLNDA #218549
Active Ingredients: BENZGALANTAMINE GLUCONATE
Submission Classification*: Type 2 - New Active Ingredient and Type 3 - New Dosage Form
Review Priority**: Standard
Company: ALPHA COGNITION

Approval Date: 07/29/2024
Drug Name: TEZRULYNDA #218139
Active Ingredients: TERAZOSIN HYDROCHLORIDE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: NOVITIUM PHARMA

Upcoming Advisory Board Meetings

09/09/2024 Antimicrobial Drugs Advisory Committee Meeting- 09:00 AM EDT to 04:15 PM EDT

09/13/2024 Gastrointestinal Drugs Advisory Committee Meeting- 08:30 AM EDT to 05:00 PM EDT

09/18/2024 Pediatric Advisory Committee Meeting- 10:00 AM EDT to 04:00 PM EDT

09/20/2024 Vaccines and Related Biological Products Advisory Committee Meeting- 08:30 AM EDT to 05:00 PM EDT

IMDRF publishes AI/ML guiding principles echoing US, UK, Canadian regulators (published 01-Jul-2024)
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FDA again warns Sun Pharma over Dadra facility (published 02-Jul-2024)
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EMA proposes revamping COVID-19 vaccine guidance for the post-pandemic era (published 03-Jul-2024)
Read Article on RAPS.org

FDA draft guidance aims to give companies leeway to address medical misinformation (published 08-Jul-2024)
Read Article on RAPS.org

FDA releases draft guidance on use-related risk analysis for combo products (published 09-Jul-2024)
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Industry, research push for clarity in clinical trial eligibility guidances (published 09-Jul-2024)
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Lab industry seeks more flexibility in FDA emergency enforcement guidance (published 10-Jul-2024)
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European Commission drug shortage pilot study highlights industry, regulatory challenges (published 11-Jul-2024)
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FDA issues final guidance user fees for combination products (published 16-Jul-2024)
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FDA guidance addresses developing treatments for pediatric IBD (published 17-Jul-2024)
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FDA unveils rare disease innovation hub, plans public meeting this fall (published 18-Jul-2024)
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FDA makes exception for antibody drug conjugates in mass balance studies final guidance (published 18-Jul-2024)
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FDA scolds’ Chinese firm for data integrity lapses, MIT for BIMO violations (published 19-Jul-2024)
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European Commission president proposes new legislation to boost pharma competitiveness (published 22-Jul-2024)
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Biosimilars: FDA draft guidance addresses manufacturing changes (published 22-Jul-2024)
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EMA addendum addresses vaccine development for immunocompromised people (published 23-Jul-2024)
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Oligonucleotides: EMA drafts new guideline on manufacturing and development (published 23-Jul-2024)
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FDA finds data integrity, sterility problems at Indian drugmaker (published 25-Jul-2024)
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FDA finalizes guidance on RWD from electronic health records (published 25-Jul-2024)
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FDA finalizes COVID-era guidance on container closure changes (published 26-Jun-2024)
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Swissmedic survey finds drug approval timelines slower than EMA, FDA (published 29-Jul-2024)
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FDA dings Kaleo over Instagram post with insufficient risk information (published 29-Jul-2024)
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EMA, Gates Foundation back pilot for African continental drug evaluations (published 30-Jul-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