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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.
FDA Final Guidance:
Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method (published 17-Oct-2024)
Download FDA Guidance
Postoperative Nausea and Vomiting: Developing Drugs for Prevention (published 18-Oct-2024)
Download FDA Guidance
Drug Interaction Information in Human Prescription Drug and Biological Product Labeling (published 22-Oct-2024)
Download FDA Guidance
FDA Draft Guidance:
Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers (published 02-Oct-2024)
Draft FDA Guidance
Temporary Policies for Compounding Certain Parenteral Drug Products (published 11-Oct-2024)
Draft FDA Guidance
Endosseous Dental Implants and Endosseous Dental Implant Abutments - Performance Criteria for Safety and Performance Based Pathway (15-Oct-2024)
Draft FDA Guidance
Core Patient-Reported Outcomes in Cancer Clinical Trials (published 17-Oct-2024)
Draft FDA Guidance
Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development (published 17-Oct-2024)
Draft FDA Guidance
M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms (published 30-Oct-2024)
Draft FDA Guidance
Monthly FDA Approvals
Approval Date: 10/04/2024
Drug Name: PYRIDOSTIGMINE BROMIDENDA #217604
Active Ingredients: PYRIDOSTIGMINE BROMIDE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: AMNEAL
Approval Date: 10/10/2024
Drug Name: ITOVEBINDA #219249
Active Ingredients: INAVOLISIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: GENENTECH INC
Approval Date: 10/10/2024
Drug Name: IMULDOSABLA #761364
Active Ingredients: USTEKINUMAB-SRLF
Submission Classification*:
Review Priority**:
Company: ACCORD BIOPHARMA INC.
Approval Date: 10/11/2024
Drug Name: HYMPAVZIBLA #761369
Active Ingredients: MARSTACIMAB-HNCQ
Submission Classification*:
Review Priority**:
Company: PFIZER INC
Approval Date: 10/16/2024
Drug Name: VYALEVNDA #216962
Active Ingredients: FOSCARBIDOPA; FOSLEVODOPA
Submission Classification*: Type 3 - New Dosage Form and Type 4 - New Combination
Review Priority**: Standard
Company: ABBVIE
Approval Date: 10/18/2024
Drug Name: LASIX ONYUNDA #217294
Active Ingredients: FUROSEMIDE INJECTION
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: SQ INNOVATION, INC
Approval Date: 10/18/2024
Drug Name: VYLOYBLA #761365
Active Ingredients: ZOLBETUXIMAB-CLZB
Submission Classification*:
Review Priority**:
Company: ASTELLAS
Approval Date: 10/25/2024
Drug Name: ORLYNVAHNDA #213972
Active Ingredients: SULOPENEM ETZADROXIL;PROBENECID
Submission Classification*: Type 1 - New Molecular Entity and Type 4 - New Combination
Review Priority**: Priority
Company: ITERUM THERAPEUTICS US LTD
Approval Date: 10/30/2024
Drug Name: EPINEPHRINENDA #215425
Active Ingredients: EPINEPHRINE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: FRESENIUS KABI USA
Upcoming Advisory Board Meetings
11/19/2024 Drug Safety and Risk Management Advisory Committee and Psychopharmacologic Drugs Advisory Committee Meeting- 08:30 AM EDT to 5:30 PM EDT
11/20/2024- 11/21/2024 Digital Health Advisory Committee Meeting- 09:00 AM EDT to 06:00 PM EDT
11/21/2024 Cellular, Tissue, and Gene Therapies Advisory Committee Meeting- 10:00 AM EDT to 04:00 PM EDT
12/04/2024 Pharmacy Compounding Advisory Committee Meeting- 08:00 AM EDT to 03:00 PM EDT
12/12/2024 Vaccines and Related Biological Products Advisory Committee Meeting- 08:30 AM EDT to 05:30 PM EDT
FDA pulls the trigger on major agency reorganization (published 01-Oct-2024)
Read Article on RAPS.org
EMA concerned about MAA delays, working on solutions (published 02-Oct-2024)
Read Article on RAPS.org
FDA finalizes Q&A guidance on electronic records in clinical trials (published 02-Oct-2024)
Read Article on RAPS.org
Diversity action plans: Stakeholders seek clarity on demographic data, enrollment, and global trials (published 03-Oct-2024)
Read Article on RAPS.org
Stakeholders warn of potential burdens in FDA’s drug delivery guidance (published 04-Oct-2024)
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FDA Science Board recommends creation of centralized new alternative methods office (published 07-Oct-2024)
Read Article on RAPS.org
FDA compliance official highlights priorities, return to onsite inspections, and warning letter trends (published 07-Oct-2024)
Read Article on RAPS.org
MDCG issues guidance and templates on CAPA plans (published 08-Oct-2024)
Read Article on RAPS.org
EU regulators propose updated medicines strategy to include AI growth, new pharma legislation (published 10-Oct-2024)
Read Article on RAPS.org
ICH survey shows uptick in guideline implementation (published 11-Oct-2024)
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Industry stakeholders call for changes to ICH M14 RWD guideline (published 14-Oct-2024)
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FDA issues emergency compounding guidance to address drug shortages due to recent hurricanes (published 14-Oct-2024)
Read Article on RAPS.org
Study finds a majority of new drug approvals subject to PREA requirements have ongoing postmarketing studies (published 15-Oct-2024)
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Health Canada digital health head says AI/ML guidance imminent (published 15-Oct-2024)
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FDA officials outline need for oversight of AI in healthcare, biomedicine (published 17-Oct-2024)
Read Article on RAPS.org
FDA drafts guidance on drug interaction labeling (published 23-Oct-2024)
Read Article on RAPS.org
Industry rejects FDA’s proposal for biosimilar product-specific guidance (published 24-Oct-2024)
Read Article on RAPS.org
Tarver says clinical trial diversity action plans are a marketing opportunity (published 24-Oct-2024)
Read Article on RAPS.org
Notified body official shares recommendations for successful PMCF plans (published 30-Oct-2024)
Read Article on RAPS.org
EMA proposes updated guideline on peripheral arterial occlusive disease treatments (published 31-Oct-2024)
Read Article on RAPS.org
- Review the recording from our webinar: Align New Oncology Drug Development with FDA's Project FrontRunner
- 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