Regulatory Guidance Monthly Review - July 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 July 2023.

FDA Final Guidance

Questions and Answers | M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk (published 25-Jul-2023)
Download FDA Guidance

M7(R2) ADDENDUM: APPLICATION OF THE PRINCIPLES OF THE ICH M7 GUIDELINE TO CALCULATION OF COMPOUND-SPECIFIC ACCEPTABLE INTAKES (published 25-Jul-2023)
Download FDA Guidance

CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality (published 26-Jul-2023)
Download FDA Guidance

Assessing User Fees Under the Biosimilar User Fee Amendments of 2022 (published 31-Jul-2023)
Download FDA Guidance

FDA Draft Guidance:

Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development (published 12-Jul-2023)
Draft FDA Guidance

Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products (published 13-Jul-2023)
Draft FDA Guidance

Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act (published 14-Jul-2023)
Draft FDA Guidance

Monthly FDA Approvals

Approval Date: 07/12/2023
Drug Name: DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATENDA #211868
Active Ingredients: DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Submission Classification*: Type 4 - New Combination
Review Priority**: Standard
Company: EMCURE PHARMS LTD

Approval Date: 07/17/2023
Drug Name: BEYFORTUSBLA #761328
Active Ingredients: NIRSEVIMAB-ALIP
Submission Classification*:
Review Priority**:
Company: ASTRAZENECA AB

Approval Date: 07/18/2023
Drug Name: DOLUTEGRAVIR;EMTRICITABINE;TENOFOVIR ALAFENAMIDENDA #215187
Active Ingredients: DOLUTEGRAVIR;EMTRICITABINE;TENOFOVIR ALAFENAMIDE
Submission Classification*: Type 4 - New Combination
Review Priority**: Standard
Company: LUPIN PHARMS

Approval Date: 07/20/2023
Drug Name: VANFLYTANDA #216993
Active Ingredients: QUIZARTINIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: DAIICHI SANKYO

Approval Date: 07/21/2023
Drug Name: YCANTHNDA #212905
Active Ingredients: CANTHARIDIN
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: VERRICA PHARMACEUTICALS INC

Approval Date: 07/24/2023
Drug Name: XDEMVYNDA #217603
Active Ingredients: LOTILANER
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: TARSUS PHARMACEUTICALS, INC.

Approval Date: 07/26/2023
Drug Name: MEROPENEMNDA #215212
Active Ingredients: MEROPENEM
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: HQ SPECLT PHARMA

Approval Date: 07/28/2023
Drug Name: RIVIVENDA #217722
Active Ingredients: NALOXONE HYDROCHLORIDE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Priority
Company: HARM REDUCTION THERAPEUTICS

Upcoming Advisory Board Meetings

09/11/2023- 09/12/2023- Meeting of the Nonprescription Drugs Advisory Committee Meeting Announcement- 09:00 AM EDT to 02:30 PM EDT

09/13/2023- Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement- 09:00 AM EDT- 04:00 PM EDT

09/19/2023- 09/20/2023- Pediatric Advisory Committee Meeting Announcement- 09:00 AM EDT- 01:00 PM EDT

09/27/2023- Cellular, Tissue, and Gene Therapies Advisory Committee Meeting- 10:00 AM EDT- 06:00 AM EDT

Expert: ‘Significant advances’ made in RWD use thanks to new regulatory initiatives (published 05-Jul-2023)
Read Article on RAPS.org

FDA issues revised site selection model tying surveillance inspections to location (published 06-Jul-2023)
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FDA follows most adcomm recommendations, study says (published 07-Jul-2023)
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Stakeholders want consistency, more examples in last FDA draft guidance on patient-focused drug development (published 07-Jul-2023)
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ICH paper calls for ‘stepwise’ harmonization of RWE (published 07-Jul-2023)
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FDA describes agency’s initiatives to accommodate growth in cell and gene therapy fields (published 10-Jul-2023)
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Outlook for clinical trials: Digital and patient centric (published 11-Jul-2023)
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FDA sees rapid uptick in drug and biologic submissions with AI/ML components (published 12-Jul-2023)
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FDA revises IEM drug draft guidance to clarify food standards, use of control groups (published 13-Jul-2023)
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European Commission monitoring antibiotic use for shortages, asks firms to ramp up production (published 17-Jul-2023)
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FDA issues draft guidance on reporting manufacturing changes for gene therapies (published 17-Jul-2023)
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FDA warns device makers for GMP issues, unauthorized uses (published 18-Jul-2023)
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WHO seeks to align biowaiver policy with ICH guidelines (published 18-Jul-2023)
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Commenters push back on FDA’s plans for PREA compliance, pediatric exclusivity (published 19-Jul-2023)
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Advanced manufacturing: FDA official sees room for growth (published 19-Jul-2023)
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EMA details lifecycle approach to AI/ML drug development in new reflection paper (published 20-Jul-2023)
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Industry expert details advantages of continuous manufacturing (published 21-Jul-2023)
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FDA warns API manufacturer, OTC maker for sloppy GMP oversight (published 21-Jul-2023)
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FDA’s Marks weighs in on adcomm reform (published 21-Jul-2023)
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WHO proposes best practices for clinical trials (published 24-Jul-2023)
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Stakeholders call for knowledge sharing, patient voices in rare disease endpoint pilot (published 26-Jul-2023)
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FDA finalizes guidance on drug quality consensus standards recognition program (published 26-Jul-2023)
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FDA announces completion of first joint assessment with EMA in ICMRA pilot (published 28-Jul-2023)
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Pharmaceutical distributors seek two-year delay in DSCSA tracking rules (published 28-Jul-2023)
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Stakeholders want clearer terms in FDA's generally accepted scientific knowledge guidance (published 31-Jul-2023)
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• 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