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Fierce Biotech Summit 2024
Meet Veristat in Boston at the Fierce Biotech Summit Conference | September 30 - October 1 in Boston, Massachusetts
We...
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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FDA Draft Guidance:
REMS Logic Model: A Framework to Link Program Design With Assessment (published 07-May-2024)
Draft FDA Guidance
Platform Technology Designation Program for Drug Development (published 28-May-2024)
Draft FDA Guidance
Monthly FDA Approvals
Approval Date: 05/01/2024
Drug Name: MYHIBBINNDA #216482
Active Ingredients: MYCOPHENOLATE MOFETIL
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: AZURITY
Approval Date: 05/16/2024
Drug Name: IMDELLTRABLA #761344
Active Ingredients: TARLATAMAB-DLLE
Submission Classification*:
Review Priority**:
Company: AMGEN INC
Approval Date: 05/20/2024
Drug Name: YESAFILIBLA #761274
Active Ingredients: AFLIBERCEPT-JBVF
Submission Classification*:
Review Priority**:
Company: BIOCON BIOLOGICS INC
Approval Date: 05/20/2024
Drug Name: OPUVIZBLA #761350
Active Ingredients: AFLIBERCEPT-YSZY
Submission Classification*:
Review Priority**:
Company: SAMSUNG BIOEPIS CO LTD
Approval Date: 05/24/2024
Drug Name: ONYDA XRNDA #217645
Active Ingredients: CLONIDINE HYDROCHLORIDE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: TRIS PHARMA INC
Approval Date: 05/28/2024
Drug Name: BKEMVBLA #761333
Active Ingredients: ECULIZUMAB-AEEB
Submission Classification*:
Review Priority**:
Company: AMGEN INC
Upcoming Advisory Board Meetings
06/10/2024- Peripheral and Central Nervous System Drugs Advisory Committee Meeting- 09:00 AM EDT to 05:00 PM EDT
WHO recommends risk management plans for high-risk excipients (published 01-May-2024)
Read Article on RAPS.org
Stakeholders push for greater inclusion in FDA’s race and ethnicity data collection guidance (published 02-May-2024)
Read Article on RAPS.org
ORA chief says funding needed to keep pace with growing inspectional inventory (published 02-May-2024)
Read Article on RAPS.org
Stakeholders welcome FDA’s informed consent ‘key information’ guidance (published 06-May-2024)
Read Article on RAPS.org
Top FDA officials discuss PDUFA hiring, rapid communication, and international collaboration efforts (published 09-May-2024)
Read Article on RAPS.org
Stakeholders provide feedback on FDA draft guidance on drug development for early Alzheimer's disease (published 17-May-2024)
Read Article on RAPS.org
FDA concerned about potential device shortages due to new EtO limits (published 20-May-2024)
Read Article on RAPS.org
Stakeholders want more early FDA communication options, shorter Q-Sub response timelines (published 23-May-2024)
Read Article on RAPS.org
FDA: New logic model sets structured approach to REMS development (published 23-May-2024)
Read Article on RAPS.org
ICH adopts M12 guideline on drug interaction studies, releases draft M14 guidance on RWD (published 28-May-2024)
Read Article on RAPS.org
FDA issues platform technology designation draft guidance (published 28-May-2024)
Read Article on RAPS.org
European Commission adopts rules for joint clinical assessments (published 29-May-2024)
Read Article on RAPS.org
FDA reorganization greenlit, slated to begin in October (published 30-May-2024)
Read Article on RAPS.org
FDA plans to release AI drug development guidance this year (published 30-May-2024)
Read Article on RAPS.org
FDA official offers updates on C3TI, knowledge repository (published 31-May-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