Regulatory Guidance Monthly Review - August 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 August 2023.

FDA Final Guidance

Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act (published 04-Aug-2023)
Download FDA Guidance

Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (published 07-Aug-2023)
Download FDA Guidance

Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (published 15-Aug-2023)
Download FDA Guidance

Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies (published 28-Aug-2023)
Download FDA Guidance

FDA Draft Guidance:

Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief (published 01-Aug-2023)
Draft FDA Guidance

PDUFA Waivers, Reductions, and Refunds for Fixed- Combinations and Single-Entity Versions of Previously Approved Antiretrovirals under PEPFAR (published 03-Aug-2023)
Draft FDA Guidance

QTc Information in Human Prescription Drug and Biological Product Labeling (published 08-Aug-2023)
Draft FDA Guidance

Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products (published 10-Aug-2023)
Draft FDA Guidance

Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry (published 11-Aug-2023)
Draft FDA Guidance

Classification Categories for Certain Supplements Under BsUFA III (published 11-Aug-2023)
Draft FDA Guidance

Monthly FDA Approvals

Approval Date: 08/04/2023
Drug Name: IZERVAYNDA #217225
Active Ingredients: AVACINCAPTAD PEGOL SODIUM
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: IVERIC BIO

Approval Date: 08/09/2023
Drug Name: TALVEYBLA #761342
Active Ingredients: TALQUETAMAB-TGVS
Submission Classification*:
Review Priority**:
Company: JANSSEN BIOTECH

Approval Date: 08/11/2023
Drug Name: AKEEGANDA #216793
Active Ingredients: ABIRATERONE ACETATE; NIRAPARIB TOSYLATE
Submission Classification*: Type 4 - New Combination
Review Priority**: Priority
Company: JANSSEN BIOTECH

Approval Date: 08/14/2023
Drug Name: HEPZATONDA #201848
Active Ingredients: MELPHALAN HYDROCHLORIDE
Submission Classification*: Type 4 - New Combination
Review Priority**: Standard
Company: DELCATH SYSTEMS INC

Approval Date: 08/14/2023
Drug Name: ABACAVIR; DOLUTEGRAVIR; LAMIVUDINENDA #217070
Active Ingredients: ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Priority
Company: AUROBINDO PHARMA USA

Approval Date: 08/14/2023
Drug Name: ELREXFIOBLA #761345
Active Ingredients: ELRANATAMAB
Submission Classification*:
Review Priority**:
Company: PFIZER INC

Approval Date: 08/16/2023
Drug Name: SOHONOSNDA #215559
Active Ingredients: PALOVAROTENE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: IPSEN INC

Approval Date: 08/16/2023
Drug Name: ABACAVIR; DOLUTEGRAVIR; LAMIVUDINENDA #218193
Active Ingredients: ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE
Submission Classification*: Type 4 - New Combination
Review Priority**: Priority
Company: MYLAN PHARMS INC

Approval Date: 08/18/2023
Drug Name: MELPHALAN HYDROCHLORIDENDA #217110
Active Ingredients: MELPHALAN HYDROCHLORIDE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: APOTEX

Approval Date: 08/18/2023
Drug Name: VEOPOZBLA #761339
Active Ingredients: POZELIMAB-BBFG
Submission Classification*:
Review Priority**:
Company: REGENERON PHARMACEUTICALS

Approval Date: 08/18/2023
Drug Name: EYLEA HDBLA #761355
Active Ingredients: AFLIBERCEPT
Submission Classification*:
Review Priority**:
Company: REGENERON PHARMACEUTICALS

Approval Date: 08/22/2023
Drug Name: FOCINVEZNDA #216686
Active Ingredients: FOSAPREPITANT
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: Spes Pharmaceuticals Inc.

Approval Date: 08/24/2023
Drug Name: TYRUKOBLA #761322
Active Ingredients: NATALIZUMAB-SZTN
Submission Classification*:
Review Priority**:
Company: SANDOZ INC

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

FDA, DEA asks stimulant makers to boost production or pass on allotments to other manufacturers amid shortages (published 01-Aug-2023)
Read Article on RAPS.org

FDA warns Intas, Centaur and Baxter over GMP violations at Indian facilities (published 02-Aug-2023)
Read Article on RAPS.org

Lawmakers, concerned about shortages, urge FDA to assess DSCSA readiness (published 03-Aug-2023)
Read Article on RAPS.org

FDA working to streamline adcomm system, hybrid model here to stay (published 03-Aug-2023)
Read Article on RAPS.org

FDA warns two drugmakers over DEG, EG testing lapses (published 03-Aug-2023)
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Industry groups call for better alignment between decentralized, centralized trials (published 04-Aug-2023)
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Drugmakers ask FDA to reconsider concomitant treatment in migraine drug guidance (published 07-Aug-2023)
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FDA finalizes guidance on DSCSA waivers, exceptions and exemptions (published 07-Aug-2023)
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FDA sets acceptable intake limits for nitrosamines in drugs (published 07-Aug-2023)
Read Article on RAPS.org

QTc: FDA proposes labeling for heart drugs with heart rhythm risk (published 08-Aug-2023)
Read Article on RAPS.org

FDA wants feedback on small dispensers’ DSCSA tracking readiness (published 09-Aug-2023)
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FDA drafts guidance on classification category for biosimilar supplements (published 10-Aug-2023)
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Stakeholders seek risk-based approach from FDA on regulating AI/ML for drug development (published 10-Aug-2023)
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More than half of novel drug approvals were based on single studies in 2022 (published 11-Aug-2023)
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Biosimilar meetings: FDA updates draft guidance for BsUFA III (published 11-Aug-2023)
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Pharma groups slam EU’s compulsory licensing proposal (published 14-Aug-2023)
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FDA draft guidance focuses on postapproval trial diversity data (published 14-Aug-2023)
Read Article on RAPS.org

FDA issues final guidance on obtaining informed consent in drug and device clinical trials (published 15-Aug-2023)
Read Article on RAPS.org

Experts worried about exceptions process handling under DSCSA (published 18-Aug-2023)
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FDA warns Integra LifeSciences over endotoxin testing, complaint investigations (published 21-Aug-2023)
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Swiss drug review times trail FDA and EMA, increased due to COVID (published 21-Aug-2023)
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Califf: FDA will be a ‘more activist’ agency (published 24-Aug-2023)
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FDA seeks information on global API market (published 25-Aug-2023)
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FDA gives firms one-year reprieve from DSCSA track and trace requirements (published 25-Aug-2023)
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Psychedelic drug trial guidance: Commenters see vital role for psychotherapy (published 29-Aug-2023)
Read Article on RAPS.org

Stakeholders want FDA to consider latest advancements in diabetes drug efficacy draft guidance (published 29-Aug-2023)
Read Article on RAPS.org

Stakeholders disagree on FDA’s approach to wholesaling compounded drugs (published 30-Aug-2023)
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WHO guideline: Pharmaceutical quality control labs should plan ahead for operational disruptions (published 30-Aug-2023)
Read Article on RAPS.org

FDA finalizes guidance on real-world evidence in drug approvals (published 31-Aug-2023)
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