Regulatory Guidance Monthly Review - November 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 November 2023.

FDA Final Guidance

Submitting Patient-Reported Outcome Data in Cancer Clinical Trials (published 06-Nov-2023)
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Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory (published 06-Nov-2023)
Download FDA Guidance

Real-Time Oncology Review (RTOR) (published 07-Nov-2023)
Download FDA Guidance

COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers Guidance for Industry (published 07-Nov-2023)
Download FDA Guidance

COVID-19: Developing Drugs and Biological Products for Treatment or Prevention (published 24-Nov-2023)
Download FDA Guidance

FDA Draft Guidance:

Translation of Good Laboratory Practice Study Reports: Questions and Answers (published 21-Nov-2023)
Draft FDA Guidance

Monthly FDA Approvals

Approval Date: 11/01/2023
Drug Name: VOQUEZNANDA #215151
Active Ingredients: VONOPRAZAN FUMARATE
Submission Classification*: Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated
Review Priority**: Standard
Company: PHATHOM

Approval Date: 11/03/2023
Drug Name: ZITUVIMETNDA #216743
Active Ingredients: SITAGLIPTIN;METFORMIN HYDROCHLORIDE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: ZYDUS WORLDWIDE DMCC

Approval Date: 11/08/2023
Drug Name: FRUZAQLANDA #217564
Active Ingredients: FRUQUINTINIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: TAKEDA PHARMS USA

Approval Date: 11/08/2023
Drug Name: ZEPBOUNDNDA #217806
Active Ingredients: TIRZEPATIDE
Submission Classification*: Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated
Review Priority**: Priority
Company: ELI LILLY AND CO

Approval Date: 11/15/2023
Drug Name: DEFENCATHNDA #214520
Active Ingredients: TAUROLIDINE AND HEPARIN SODIUM
Submission Classification*: Type 1 - New Molecular Entity and Type 4 - New Combination
Review Priority**: Priority
Company: CORMEDIX INC

Approval Date: 11/15/2023
Drug Name: AUGTYRONDA #218213
Active Ingredients: REPOTRECTINIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: BRISTOL-MYERS SQUIBB CO

Approval Date: 11/16/2023
Drug Name: TRUQAPNDA #218197
Active Ingredients: CAPIVASERTIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: ASTRAZENECA PHARMS

Approval Date: 11/16/2023
Drug Name: RYZNEUTABLA #761134
Active Ingredients: EFBEMALENOGRASTIM ALFA-VUXW
Submission Classification*:
Review Priority**:
Company: EVIVE BIOTECHNOLOGY

Approval Date: 11/27/2023
Drug Name: OGSIVEONDA #217677
Active Ingredients: NIROGACESTAT
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: SPRINGWORKS THERAPEUTICS INC

Approval Date: 11/29/2023
Drug Name: ALVAIZNDA #216774
Active Ingredients: ELTROMBOPAG CHOLINE
Submission Classification*: Type 2 - New Active Ingredient
Review Priority**: Standard
Company: TEVA PHARMS

Upcoming Advisory Board Meetings

No Upcoming meetings in December

FDA notes “continued growth” of Orbis collaborative review program, adds EMA as observer (published 01-Nov-2023)
Read Article on RAPS.org

FDA reiterates guidance plans on distributed and point-of-care manufacturing (published 03-Nov-2023)
Read Article on RAPS.org

FDA ramps up monitoring in high-risk areas following DEG-contamination deaths overseas (published 06-Nov-2023)
Read Article on RAPS.org

FDA publishes two guidances on collecting clinical outcomes data (published 06-Nov-2023)
Read Article on RAPS.org

FDA finalizes guidance on real-time review of oncology drugs (published 07-Nov-2023)
Read Article on RAPS.org

ICH adopts guidelines on viral safety evaluation and analytical method development (published 08-Nov-2023)
Read Article on RAPS.org

EMA announces first drugs to publish ePI that can be used across member states (published 10-Nov-2023)
Read Article on RAPS.org

EMA plans major revamp of regulatory website (published 10-Nov-2023)
Read Article on RAPS.org

FDA announces OPQ reorganization to alleviate ‘long-standing pain points’ (published 13-Nov-2023)
Read Article on RAPS.org

Stakeholders not working together to develop AI standards, expert laments (published 15-Nov-2023)
Read Article on RAPS.org

Industry calls for revisions in FDA’s CGT manufacturing change guidance (published 16-Nov-2023)
Read Article on RAPS.org

Studies: Drugmakers are gaming the patent system with misrepresentations, ancillary patents (published 16-Nov-2023)
Read Article on RAPS.org

Stakeholders urge FDA to retain interchangeability statements on biosimilar labeling (published 21-Oct-2023)
Read Article on RAPS.org

Pharma groups fight proposed ban on titanium dioxide in Europe (published 27-Nov-2023)
Read Article on RAPS.org

FDA outlines process for recognizing standards for regenerative medicines (published 28-Nov-2023)
Read Article on RAPS.org

FDA investigates risk of secondary malignancies with CAR T-cell therapy (published 30-Nov-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