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Advanced Therapies Congress
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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FDA Draft Guidance: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