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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 January 2024.
FDA Final Guidance
Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin (published 10-Jan-2024)
Download FDA Guidance
Human Gene Therapy Products Incorporating Human Genome Editing (published 29-Jan-2024)
Download FDA Guidance
Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products (published 31-Jan-2024)
Download FDA Guidance
FDA Draft Guidance:
Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products (published 30-Jan-2024)
Draft FDA Guidance
Monthly FDA Approvals
Approval Date: 01/05/2024
Drug Name: ZELSUVMINDA #217424
Active Ingredients: BERDAZIMER SODIUM
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: LNHC
Approval Date: 01/18/2024
Drug Name: DOLUTEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDENDA #212427
Active Ingredients: DOLUTEGRAVIR;EMTRICITABINE;TENOFOVIR ALAFENAMIDE
Submission Classification*: Type 4 - New Combination
Review Priority**: Standard
Company: HETERO LABS LTD III
Upcoming Advisory Board Meetings
03/05/2024- Meeting of the Medical Imaging Drug Advisory Committee Meeting- 09:00 AM EDT to 5:30 PM EDT
03/14/2024- Meeting of the Oncologic Advisory Meeting- 9:30 AM EDT to 3:00 PM EDT
03/15/2024- Meeting of the Oncologic Advisory Meeting- 8:30 AM EDT to 5:30 PM EDT
FDA CGT draft guidance focuses on potency assurance strategy (published 02-Jan-2024)
Read Article on RAPS.org
FDA finalizes guidance to limit use of benzene in drug products (published 02-Jan-2024)
Read Article on RAPS.org
FDA adds microbiological assessments to ophthalmic drug quality guidance (published 03-Jan-2024)
Read Article on RAPS.org
Industry groups seek changes to FDA’s remote interactive evaluation guidance (published 04-Jan-2024)
Read Article on RAPS.org
GOP lawmakers prod FDA over internal scientific disputes resolution process (published 04-Jan-2024)
Read Article on RAPS.org
FDA considers issuing more final guidances without comment period (published 05-Jan-2024)
Read Article on RAPS.org
FDA issues final guidance on rare disease drug development (published 09-Jan-2024)
Read Article on RAPS.org
CDER notches uptick in novel drug approvals in 2023 (published 09-Jan-2024)
Read Article on RAPS.org
Marks discusses CAR-Ts, CRISPR and START at regenerative medicine meeting (published 09-Jan-2024)
Read Article on RAPS.org
Drugmakers seek details on INTERACT meetings (published 10-Jan-2024)
Read Article on RAPS.org
FDA eyes collaborative review pilot for gene therapies (published 12-Jan-2024)
Read Article on RAPS.org
Warning letters: Same old, same old at FDA (published 16-Jan-2024)
Read Article on RAPS.org
EMA recommended 77 drugs, rejected 3 in 2023 (published 16-Jan-2024)
Read Article on RAPS.org
CDER’s Office of Compliance highlights enforcement actions in 2023 (published 17-Jan-2024)
Read Article on RAPS.org
Pharma industry questions FDA on platform technology designation program (published 23-Jan-2024)
Read Article on RAPS.org
EMA updates SME guide to reflect clinical trial reporting requirements (published 24-Jan-2024)
Read Article on RAPS.org
FDA updates guidance on remote regulatory assessments (published 29-Jan-2024)
Read Article on RAPS.org
Clinical trials: FDA proposes new standards for collecting race, ethnicity data (published 30-Jan-2024)
Read Article on RAPS.org
FDA finalizes guidance on developing, manufacturing CAR T therapies (published 30-Jan-2024)
Read Article on RAPS.org
FDA: Genome editing therapies may use accelerated approval pathway (published 30-Jan-2024)
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