3 min read
Product Launch Readiness Zürich
Join Us for an Exclusive Conference on Product Launch Readiness - Zürich, 10th April 2025, 17:00 CEST
3 min read
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:
Institutional Review Board (IRB) Written Procedures (published 05-Feb-2025)
Download FDA Guidance
Monthly FDA Approvals
Approval Date: 02/02/2025
Drug Name: Carbon Dioxide, USPNDA #220266
Active Ingredients: Carbon Dioxide
Submission Classification*: Medical Gas
Review Priority**: Unknown
Company: WELDERS SUPPLY COMPANY OF LOUISVILLE INC
Approval Date: 02/03/2025
Drug Name: ONAPGONDA #214056
Active Ingredients: APOMORPHINE HYDROCHLORIDE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: MDD US
Approval Date: 02/07/2025
Drug Name: EMBLAVEONDA #217906
Active Ingredients: AVIBACTAM SODIUM; AZTREONAM
Submission Classification*: Type 4 - New Combination
Review Priority**: Priority
Company: ABBVIE
Approval Date: 02/11/2025
Drug Name: EVRYSDINDA #219285
Active Ingredients: RISDIPLAM
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: GENENTECH INC
Approval Date: 02/11/2025
Drug Name: GOMEKLINDA #219379
Active Ingredients: MIRDAMETINIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: SPRINGWORKS
Approval Date: 02/11/2025
Drug Name: GOMEKLINDA #219389
Active Ingredients: MIRDAMETINIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: SPRINGWORKS
Approval Date: 02/13/2025
Drug Name: DENOSUMAB-DSSBBLA #761392
Active Ingredients: DENOSUMAB-DSSB
Submission Classification*:
Review Priority**:
Company: SAMSUNG BIOEPIS CO LTD
Approval Date: 02/13/2025
Drug Name: OSPOMYVBLA #761392
Active Ingredients: DENOSUMAB-DSSB
Submission Classification*:
Review Priority**:
Company: SAMSUNG BIOEPIS CO LTD
Approval Date: 02/13/2025
Drug Name: XBRYKBLA #761392
Active Ingredients: DENOSUMAB-DSSB
Submission Classification*:
Review Priority**:
Company: SAMSUNG BIOEPIS CO LTD
Approval Date: 02/14/2025
Drug Name: ROMVIMZANDA #219304
Active Ingredients: VIMSELTINIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: DECIPHERA PHARMS
Approval Date: 02/14/2025
Drug Name: MERILOGBLA #761325
Active Ingredients: INSULIN ASPART-SZJJ
Submission Classification*:
Review Priority**:
Company: SANOFI-AVENTIS U.S. LLC
Approval Date: 02/14/2025
Drug Name: MERILOG SOLOSTARBLA #761325
Active Ingredients: INSULIN ASPART-SZJJ
Submission Classification*:
Review Priority**:
Company: SANOFI-AVENTIS U.S. LLC
Approval Date: 02/19/2025
Drug Name: NILOTINIB D-TARTRATENDA #218922
Active Ingredients: NILOTINIB D-TARTRATE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: CIPLA
Approval Date: 02/21/2025
Drug Name: DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDENDA #218038
Active Ingredients: DILTIAZEM HYDROCHLORIDE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: HQ SPCLT PHARMA
Approval Date: 02/21/2025
Drug Name: CTEXLINDA #219488
Active Ingredients: CHENODIOL
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Priority
Company: MIRUM
Approval Date: 02/24/2025
Drug Name: MIUDELLANDA #218201
Active Ingredients: COPPER
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: SEBELA WOMENS HEALTH INC
Approval Date: 02/28/2025
Drug Name: EPINEPHRINENDA #218475
Active Ingredients: EPINEPHRINE;SODIUMCHLORIDE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: BAXTER HLTHCARE CORP
Approval Date: 02/28/2025
Drug Name: STOBOCLOBLA #761404
Active Ingredients: DENOSUMAB-BMWO
Submission Classification*:
Review Priority**:
Company: CELLTRION INC
Study: Sponsors often submit different clinical evidence to FDA, EMA, for cell and gene therapies (published 03-Feb-2025)
Read Article on RAPS.org
MHRA drafts mRNA cancer immunotherapy guidance (published 03-Feb-2025)
Read Article on RAPS.org
Stakeholders seek more in-person meetings and faster guidance development from FDA (published 06-Feb-2025)
Read Article on RAPS.org
EMA adopts guideline on requirements for clinical-stage ATMPs (published 07-Feb-2025)
Read Article on RAPS.org
Trump's 10-for-1 order puts pressure on FDA to find regulations to nix (published 07-Feb-2025)
Read Article on RAPS.org
Drugmakers receive FDA warning letter for cGMP violations, failure to obtain IND approval (published 11-Feb-2025)
Read Article on RAPS.org
EMA’s revised reflection paper offers ‘snapshot’ of animal testing alternatives (published 13-Feb-2025)
Read Article on RAPS.org
EMA proposes new guideline on model-informed drug development (published 14-Feb-2025)
Read Article on RAPS.org
Stakeholders seek clarity, case studies on patient experience data in applications (published 17-Feb-2025)
Read Article on RAPS.org
Warning letters issued for cGMP violations, refusing entry, and falsifying documents (published 18-Feb-2025)
Read Article on RAPS.org
Wilson Bryan: Return-to-office mandate will weaken FDA, impact hiring (published 20-Feb-2025)
Read Article on RAPS.org
FDA rehires some laid-off staff, though some fear lasting damage to trust (published 24-Feb-2025)
Read Article on RAPS.org
Stakeholders seek clarification, flexibility, expansion of CGT guidance (published 25-Feb-2025)
Read Article on RAPS.org
EMA publishes work plans for infectious diseases and oncology (published 25-Feb-2025)
Read Article on RAPS.org
FDA, industry look to revisit regulatory framework for HCT/Ps (published 26-Feb-2025)
Read Article on RAPS.org
Stakeholders take issue with FDA’s guidance on drugs with mutagenic potential (published 28-Feb-2025)
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