Regulatory Guidance Monthly Review - December 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 December 2023.

FDA Final Guidance

Data Standards for Drug and Biological Product Submissions Containing Real-World Data (published 21-Dec-2023)
Download FDA Guidance

Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization (published 21-Dec-2023)
Download FDA Guidance

Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products (published 22-Dec-2023)
Download FDA Guidance

Digital Health Technologies for Remote Data Acquisition in Clinical Investigations (published 22-Dec-2023)
Download FDA Guidance

Rare Diseases: Considerations for the Development of Drugs and Biological Products (published 26-Dec-2023)
Download FDA Guidance

FDA Draft Guidance:

Advanced Manufacturing Technologies Designation Program (published 12-Dec-2023)
Draft FDA Guidance

Clinical Pharmacology Considerations for Peptide Drug Products (published 14-Dec-2023)
Draft FDA Guidance

Master Protocols for Drug and Biological Product Development (published 21-Dec-2023)
Draft FDA Guidance

Quality Considerations for Topical Ophthalmic Drug Products (published 27-Dec-2023)
Draft FDA Guidance

Potency Assurance for Cellular and Gene Therapy Products (published Dec-2023)
Draft FDA Guidance

Monthly FDA Approvals

Approval Date: 12/05/2023
Drug Name: PHYRAGONDA #216099
Active Ingredients: DASATINIB
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: NANOCOPOEIA

Approval Date: 12/05/2023
Drug Name: FABHALTANDA #218276
Active Ingredients: IPTACOPAN HYDROCHLORIDE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: NOVARTIS

Approval Date: 12/06/2023
Drug Name: AVZIVIBLA #761198
Active Ingredients: BEVACIZUMAB-TNJN
Submission Classification*:
Review Priority**:
Company: BIO-THERA SOLUTIONS LTD

Approval Date: 12/13/2023
Drug Name: IWILFINNDA #215500
Active Ingredients: EFLORNITHINE HYDROCHLORIDE
Submission Classification*:
Review Priority**: Priority
Company: USWM

Approval Date: 12/13/2023
Drug Name: IDOSE TRNDA #218010
Active Ingredients: TRAVOPROST
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: GLAUKOS

Approval Date: 12/14/2023
Drug Name: HYDROMORPHONE HYDROCHLORIDENDA #217812
Active Ingredients: HYDROMORPHONE HYDROCHLORIDE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: HIKMA

Approval Date: 12/15/2023
Drug Name: ZORYVENDA #217242
Active Ingredients: ROFLUMILAST
Submission Classification*: Type 3 - New Dosage Form and Type 4 - New Combination
Review Priority**: Standard
Company: ARCUTIS

Approval Date: 12/18/2023
Drug Name: FILSUVEZNDA #215064
Active Ingredients: BIRCH TRITERPENES
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: AMRYT

Approval Date: 12/21/2023
Drug Name: WAINUANDA #217388
Active Ingredients: EPLONTERSEN SODIUM
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: IONIS PHARMA INC

Approval Date: 12/22/2023
Drug Name: ABACAVIR AND LAMIVUDINENDA #204311
Active Ingredients: ABACAVIR;LAMIVUDINE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: MYLAN LABS LTD

Approval Date: 12/22/2023
Drug Name: DARUNAVIR AND RITONAVIRNDA #209847
Active Ingredients: DARUNAVIR AND RITONAVIR
Submission Classification*: Type 4 - New Combination
Review Priority**: Priority
Company: MYLAN PHARMS INC

Upcoming Advisory Board Meetings

No Upcoming meetings in January

President Biden announces new focus on supply chain security with creation of new cabinet council (published 01-Dec-2023)
Read Article on RAPS.org

FDA warning letters address CGMP, clinical study plan failures (published 04-Dec-2023)
Read Article on RAPS.org

CBER chief says pilot program will justify increasing reviewer headcount (published 04-Dec-2023)
Read Article on RAPS.org

FDA’s lack of onsite inspections may have compromised drug quality, study says (published 05-Dec-2023)
Read Article on RAPS.org

FDA ramps up routine surveillance inspections, grapples with backlog (published 07-Dec-2023)
Read Article on RAPS.org

FDA compliance chiefs detail FY2023 trends, plans for FY2024 (published 07-Dec-2023)
Read Article on RAPS.org

FDA finalizes guidance on DSCSA verification systems (published 08-Dec-2023)
Read Article on RAPS.org

Lopa Bakrania’s full-circle journey into regulatory affairs (published 12-Dec-2023)
Read Article on RAPS.org

Experts discuss red flags that can trigger legal action against drug and device makers (published 12-Dec-2023)
Read Article on RAPS.org

EU reveals essential medicines list to combat drug shortages (published 12-Dec-2023)
Read Article on RAPS.org

Experts expect opponents of LDT rule to ramp up Congressional lobbying (published 14-Dec-2023)
Read Article on RAPS.org

Industry groups express misgivings on FDA’s QMM program (published 15-Dec-2023)
Read Article on RAPS.org

EU agencies adopt workplan on AI in medicines regulation (published 18-Dec-2023)
Read Article on RAPS.org

NIST drafts differential privacy guidance to enhance individual privacy in research (published 18-Dec-2023)
Read Article on RAPS.org

Study: FDA using postmarketing requirements for oncology drugs more often to assess dose optimization (published 19-Dec-2023)
Read Article on RAPS.org

Groups seek changes to FDA’s single-trial effectiveness guidance (published 19-Dec-2023)
Read Article on RAPS.org

FDA eases informed consent requirements for minimal risk trials (published 21-Dec-2023)
Read Article on RAPS.org

FDA proposes master control trial guidance that goes beyond COVID-19 (published 22-Dec-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