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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:
No FDA final guidance for the month of April
Monthly FDA Approvals
Approval Date: 04/02/2025
Drug Name: LIBERVANTNDA #218623
Active Ingredients: DIAZEPAM
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: AQUESTIVE
Approval Date: 04/02/2025
Drug Name: VANRAFIANDA #219208
Active Ingredients: ATRASENTAN HYDROCHLORIDE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: NOVARTIS
Approval Date: 04/03/2025
Drug Name: PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINERNDA #206056
Active Ingredients: PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: B BRAUN MEDICAL INC
Approval Date: 04/09/2025
Drug Name: TRABECTEDINNDA #219617
Active Ingredients: TRABECTEDIN
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: EVER VALINJECT
Approval Date: 04/09/2025
Drug Name: JOBEVNEBLA #761175
Active Ingredients: BEVACIZUMAB-NWGD
Submission Classification*:
Review Priority**:
Company: BIOCON BIOLOGICS INC
Approval Date: 04/10/2025
Drug Name: LOPRESSORNDA #219373
Active Ingredients: METOPROLOL TARTRATE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: RUBICON
Approval Date: 04/10/2025
Drug Name: LIVMARLINDA #219485
Active Ingredients: MARALIXIBAT CHLORIDE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: MIRUM
Approval Date: 04/15/2025
Drug Name: MEZOFYNDA #211448
Active Ingredients: ARIPIPRAZOLE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: CMG PHARM CO LTD
Approval Date: 04/17/2025
Drug Name: ELIQUISNDA #220073
Active Ingredients: APIXABAN
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Priority
Company: BRISTOL
Approval Date: 04/17/2025
Drug Name: ELIQUIS SPRINKLENDA #220073
Active Ingredients: APIXABAN
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Priority
Company: BRISTOL
Approval Date: 04/22/2025
Drug Name: QAMZOVANDA #217593
Active Ingredients: MELOXICAM
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: NANJING DELOVA BIOTECH CO LTD
Approval Date: 04/23/2025
Drug Name: PENPULIMAB-KCQXBLA #761258
Active Ingredients: PENPULIMAB-KCQX
Submission Classification*:
Review Priority**:
Company: AKESO BIOPHARMA
Approval Date: 04/29/2025
Drug Name: IMAAVYBLA #761430
Active Ingredients: NIPOCALIMAB-AAHU
Submission Classification*:
Review Priority**:
Company: JANSSEN BIOTECH
Approval Date: 04/30/2025
Drug Name: ATZUMINDA #217901
Active Ingredients: DIHYDROERGOTAMINE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: SATSUMA PHARMS
Upcoming Advisory Board Meetings
05/05/2025 Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Meeting- 08:00 AM EDT to 05:00 PM EDT
05/20/2025- 5/21/2025 Oncologic Drugs Advisory Committee Meeting- 08:00 AM EDT to 05:00 PM EDT
5/22/2025 Vaccines and Related Biological Products Advisory Committee Meeting- 08:30 AM EDT- 04:30 PM EDT
FDA reissues sex-specific data guidance after sanitizing anything considered DEI-related (published 02-Apr-2025)
Read Article on RAPS.org
FDA uncovers ‘significant’ data integrity concerns at Indian CRO (published 02-Apr-2025)
Read Article on RAPS.org
FDA warns Indian firm over cleanliness and poor record keeping, US drugmaker over investigation failures (published 04-Mar-2025)
Read Article on RAPS.org
Study finds use of cancer medications declines after withdrawal of accelerated approval (published 04-Apr-2025)
Read Article on RAPS.org
EMA adopts reflection paper on RWE from noninterventional studies (published 08-Apr-2025)
Read Article on RAPS.org
Stakeholders seek clarity in FDA’s AI in regulatory decision-making draft guidance (published 14-Apr-2025)
Read Article on RAPS.org
Trump administration investigating national security risk of imported drugs (published 15-Apr-2025)
Read Article on RAPS.org
Timeliness, more guidance sought for EMA early interaction meetings (published 16-Apr-2025)
Read Article on RAPS.org
Industry supports FDA’s draft guidance on weight management drugs, suggests some refinements (published 16-Apr-2025)
Read Article on RAPS.org
ICH releases overhauled stability guideline for consultation (published 17-Apr-2025)
Read Article on RAPS.org
Europe’s pharmaceutical industry wants more clarity on ICH’s modeling guideline (published 21-Apr-2025)
Read Article on RAPS.org
FDA seeks input on using HL7 FHIR standard for collecting RWD (published 22-Apr-2025)
Read Article on RAPS.org
Experts: Look to states and the courts for shifts in vaccine policy (published 24-Apr-2025)
Read Article on RAPS.org
Advanced manufacturing: Industry tells FDA process modeling is sufficient for batch uniformity (published 28-Apr-2025)
Read Article on RAPS.org
Study: FDA approved five drugs to treat rare diseases using RWE in 2020-2022 (published 29-Apr-2025)
Read Article on RAPS.org
Taylor Mulkerin
Associate Project Manager, Regulatory Affairs
Taylor Mulkerin is an Associate Project Manager of Regulatory Affairs at Veristat. Taylor brings extensive experience supporting regulatory projects across a broad spectrum of therapeutic areas, including rare diseases, infectious diseases, neurology, cardiovascular, diabetes, oncology, atopic dermatitis, gastroenterology, and CNTF.
His expertise spans the full regulatory lifecycle—from preclinical and Phase 1–3 development through to NDA and BLA submissions, approvals, and post-approval activities. Taylor has provided project management support for key regulatory milestones such as Orphan Drug Designation (ODD), pre-IND and IND submissions, Drug Master Files (DMF), and End-of-Phase 2 (EOP2) meetings.
At Veristat, Taylor contributes to the company's impressive track record of supporting 160+ marketing applications and achieving 80+ regulatory approvals, helping sponsors navigate the complexities of drug development and regulatory submission processes.
His expertise spans the full regulatory lifecycle—from preclinical and Phase 1–3 development through to NDA and BLA submissions, approvals, and post-approval activities. Taylor has provided project management support for key regulatory milestones such as Orphan Drug Designation (ODD), pre-IND and IND submissions, Drug Master Files (DMF), and End-of-Phase 2 (EOP2) meetings.
At Veristat, Taylor contributes to the company's impressive track record of supporting 160+ marketing applications and achieving 80+ regulatory approvals, helping sponsors navigate the complexities of drug development and regulatory submission processes.