Monthly FDA Guidance and Regulatory News Review - August 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:

FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products (published 01-Aug-2024)
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M12 Drug Interaction Studies: Questions and Answers (published 02-Aug-2024)
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M12 Drug Interaction Studies (published 02-Aug-2024)
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Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases (published 08-Aug-2024)
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FDA Draft Guidance:

Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment (published 08-Aug-2024)
Draft FDA Guidance

Monthly FDA Approvals

Approval Date: 08/06/2024
Drug Name: VORANIGONDA #218784
Active Ingredients: VORASIDENIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: SERVIER

Approval Date: 08/07/2024
Drug Name: CREXONTNDA #217186
Active Ingredients: CARBIDOPA; LEVODOPA
Submission Classification*:
Review Priority**: Standard
Company: IMPAX

Approval Date: 08/07/2024
Drug Name: ZURNAI (AUTOINJECTOR)NDA #218590
Active Ingredients: NALMEFENE HYDROCHLORIDE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Priority
Company: PURDUE PHARMA LP

Approval Date: 08/07/2024
Drug Name: LYMPHIRBLA #761312
Active Ingredients: DENILEUKIN DIFTITOX-CXDL
Submission Classification*:
Review Priority**:
Company: CITIUS PHARMS

Approval Date: 08/09/2024
Drug Name: NEFFYNDA #214697
Active Ingredients: EPINEPHRINE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: ARS PHARMS OPERATION

Approval Date: 08/09/2024
Drug Name: YORVIPATHNDA #216490
Active Ingredients: PALOPEGTERIPARATIDE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: ASCENDIS PHARMA BONE

Approval Date: 08/09/2024
Drug Name: ENZEEVUBLA #761382
Active Ingredients: AFLIBERCEPT-ABZV
Submission Classification*:
Review Priority**:
Company: SANDOZ INC

Approval Date: 08/10/2024
Drug Name: CARBON DIOXIDE, USPNDA #219779
Active Ingredients: CARBON DIOXIDE
Submission Classification*:
Review Priority**: Unknown
Company: CENTRAL WELDING SUPPLY

Approval Date: 08/12/2024
Drug Name: NEMLUVIOBLA #761390
Active Ingredients: NEMOLIZUMAB-ILTO
Submission Classification*:
Review Priority**:
Company: GALDERMA LABS LP

Approval Date: 08/14/2024
Drug Name: LIVDELZINDA #217899
Active Ingredients: SELADELPAR LYSINE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: CYMABAY

Approval Date: 08/14/2024
Drug Name: NIKTIMVOBLA #761411
Active Ingredients: axatilimab-csfr
Submission Classification*:
Review Priority**:
Company: INCYTE CORP

Approval Date: 08/16/2024
Drug Name: YUTREPIANDA #213005
Active Ingredients: TREPROSTINIL
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: Liquidia Technologies, Inc.

Approval Date: 08/19/2024
Drug Name: LAZCLUZENDA #219008
Active Ingredients: LAZERTINIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: JANSSEN BIOTECH

Approval Date: 08/23/2024
Drug Name: PAVBLUBLA #761298
Active Ingredients: AFLIBERCEPT-AYYH
Submission Classification*:
Review Priority**:
Company: AMGEN INC

Approval Date: 08/26/2024
Drug Name: BORTEZOMIBNDA #212782
Active Ingredients: BORTEZOMIB
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: SHILPA MEDICARE LTD

Approval Date: 08/30/2024
Drug Name: PREVYMISNDA #219104
Active Ingredients: LETERMOVIR
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Priority
Company: MERCK SHARP DOHME

Upcoming Advisory Board Meetings

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

09/26/2024 Oncologic Drugs Advisory Committee Meeting - 08:00 AM EDT to 06:15 PM EDT

10/10/2024 Cardiovascular and Renal Drugs Advisory Committee Meeting- 08:15 AM EDT to 5:30 PM EDT

10/29/2024 Pharmacy Compounding Advisory Committee Meeting - 08:00 AM EDT to 05:00 PM EDT

EMA proposes new guideline establishing therapeutic equivalence for nasal products (published 01-Aug-2024)
Read Article on RAPS.org

FDA unveils FY 2025 user fee rates (published 01-Aug-2024)
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Study: Drugs in rare pediatric disease priority review voucher program have similar revenue to brand drugs (published 02-Aug-2024)
Read Article on RAPS.org

FDA official clarifies misconceptions around RWE in premarket submissions (published 05-Aug-2024)
Read Article on RAPS.org

EMA pilot aims to advise on orphan device development (published 05-Aug-2024)
Read Article on RAPS.org

Data integrity is ‘biggest issue’ for drug, API firms during inspections, FDA official says (published 06-Aug-2024)
Read Article on RAPS.org

ICH adopts M13A guideline on bioequivalence testing (published 06-Aug-2024)
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WHO consults on collaborative registration procedures guideline (published 07-Aug-2024)
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Expert offers advice for developing successful cell and gene therapy product quality system (published 08-Aug-2024)
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Mirati gets OPDP untitled letter for misrepresenting cancer drug efficacy (published 08-Aug-2024)
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FDA finalizes guidance on dose optimization studies for cancer drugs (published 09-Aug-2024)
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FDA updates bladder cancer drug guidance, expands single-arm study recommendations (published 12-Aug-2024)
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Stakeholders ask for more clarity, risk-based approach in CGT, TEMP draft guidance (published 12-Jul-2024)
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BIMO inspection guidance: Commenters question information access requirements (published 13-Aug-2024)
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EMA updates guidances on treatment, prophylaxis for chemical and biological agents (published 14-Aug-2024)
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FDA’s latest regulatory agenda adds proposed rules for pediatric study plans, container closure GMPs (published 15-Aug-2024)
Read Article on RAPS.org

FDA warns clinical investigator for research violations, device firm over unapproved surgical masks (published 16-Aug-2024)
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FDA finalizes guidance on PSG meetings (published 19-Aug-2024)
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Cavazzoni urges proactive measures to avoid CRLs for biologics manufacturing issues (published 20-Aug-2024)
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FDA’s updated guidance on interchangeable biosimilars gets mixed response (published 22-Aug-2024)
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ICH adopts E11A guideline to spur pediatric drug development (published 23-Aug-2024)
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Stakeholders ask for transparency, agency rationale in FDA meeting decisions (published 27-Aug-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