Monthly FDA Guidance and Regulatory News Review - September 2025

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:

Classification Categories for Certain Supplements Under BsUFA III (published 08-Sep-2025)
Download FDA Guidance

E6(R3) Good Clinical Practice (GCP) (published 08-Sep-2025)
Download FDA Guidance

Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry (published 08-Sep-2025)
Download FDA Guidance

Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications (published 11-Sep-2025)
Download FDA Guidance

Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency (published 23-Sep-2025)
Download FDA Guidance

FDA Draft Guidance:

Development of Non-Opioid Analgesics for Chronic Pain (published 11-Sep-2025)
Draft FDA Guidance

Disseminated Coccidioidomycosis: Developing Drugs for Treatment (published 17-Sep-2025)
Draft FDA Guidance

Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment (published 17-Sep-2025)
Draft FDA Guidance

Erosive Esophagitis: Developing Drugs for Treatment (published 17-Sep-2025)
Draft FDA Guidance

Safety Labeling Changes—Implementation of Section 505(o)(4) of the FD&C Act (published 18-Sep-2025)
Draft FDA Guidance

Malaria: Developing Drugs for Treatment (published 23-Sep-2025)
Draft FDA Guidance

Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations (published 24-Sep-2025)
Draft FDA Guidance

Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products (published 24-Sep-2025)
Draft FDA Guidance

Expedited Programs for Regenerative Medicine Therapies for Serious Conditions (published 24-Sep-2025)
Draft FDA Guidance

E20 Adaptive Designs for Clinical Trials (published 30-Sep-2025)
Draft FDA Guidance

Monthly FDA Approvals

Approval Date: 09/09/2025
Drug Name: ZOLYMBUSNDA #217307
Active Ingredients: BIMATOPROST
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: THEA PHARMA

Approval Date: 09/09/2025
Drug Name: INLEXZONDA #219683
Active Ingredients: GEMCITABINE HYDROCHLORIDE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Priority
Company: JANSSEN BIOTECH

Approval Date: 09/10/2025
Drug Name: KOSELUGONDA #219943
Active Ingredients: SELUMETINIB
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Priority
Company: ASTRAZENECA

Approval Date: 09/10/2025
Drug Name: KOSELUGONDA #219943
Active Ingredients: SELUMETINIB SULFATE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Priority
Company: ASTRAZENECA

Approval Date: 09/12/2025
Drug Name: ENBUMYSTNDA #219500
Active Ingredients: BUMETANIDE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: CORSTASIS THERAP

Approval Date: 09/16/2025
Drug Name: SUBVENITENDA #218879
Active Ingredients: LAMOTRIGINE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Standard
Company: OWP PHARMS

Approval Date: 09/16/2025
Drug Name: AUKELSOBLA #761436
Active Ingredients: DENOSUMAB-KYQQ
Submission Classification*:
Review Priority**:
Company: BIOCON BIOLOGICS INC

Approval Date: 09/16/2025
Drug Name: BOSAYABLA #761436
Active Ingredients: DENOSUMAB-KYQQ
Submission Classification*:
Review Priority**:
Company: BIOCON BIOLOGICS INC

Approval Date: 09/19/2025
Drug Name: FORZINITYNDA #215244
Active Ingredients: ELAMIPRETIDE HYDROCHLORIDE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: STEALTH BIOTHERAPS

Approval Date: 09/19/2025
Drug Name: KEYTRUDA QLEXBLA #761467
Active Ingredients: PEMBROLIZUMAB;BERAHYALURONIDASE ALFA-PMPH
Submission Classification*:
Review Priority**:
Company: MERCK SHARP DOHME

Approval Date: 09/24/2025
Drug Name: BONDLIDONDA #215029
Active Ingredients: LIDOCAINE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: MEDRX USA INC

Approval Date: 09/25/2025
Drug Name: INLURIYONDA #218881
Active Ingredients: IMLUNESTRANT
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: ELI LILLY CO

Approval Date: 09/25/2025
Drug Name: PALSONIFYNDA #219070
Active Ingredients: PALTUSOTINE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: CRINETICS PHARMA INC

Approval Date: 09/26/2025
Drug Name: CLOTICNDA #217628
Active Ingredients: CLOTRIMAZOLE
Submission Classification*: Type 3 - New Dosage Form
Review Priority**: Priority
Company: LABORATORIOS SALVAT SA

Approval Date: 09/26/2025
Drug Name: ENOBYBLA #761439
Active Ingredients: DENOSUMAB-QBDE
Submission Classification*:
Review Priority**:
Company: HIKMA PHARMACEUTICALS USA INC

Approval Date: 09/26/2025
Drug Name: XTRENBOBLA #761439
Active Ingredients: DENOSUMAB-QBDE
Submission Classification*:
Review Priority**:
Company: HIKMA PHARMACEUTICALS USA INC

Upcoming Advisory Board Meetings

N/A

FDA cites drugmakers and testing lab for CGMP violations (published 02-Sep-2025)
Read Article on RAPS.org

Stakeholders seek changes to FDA’s MDS drug development guidance (published 03-Sep-2025)
Read Article on RAPS.org

FDA launches program for rare diseases targeting ‘significant’ unmet need (published 03-Sep-2025)
Read Article on RAPS.org

FDA to publish CRLs ‘promptly’ as drugs are rejected (published 04-Sep-2025)
Read Article on RAPS.org

FDA’s latest regulatory agenda pulls LDT rule, spells out plans to issue a final rule on NDC (published 05-Sep-2025)
Read Article on RAPS.org

MDUFA VI: Industry, health groups call for clarity on AI, regulatory science investment (published 08-Sep-2025)
Read Article on RAPS.org

FDA finalizes guidance on therapeutic protein biosimilars (published 08-Sep-2025)
Read Article on RAPS.org

FDA warns Indian drugmaker over quality lapses, clinical researcher for enrollment issues (published 09-Sep-2025)
Read Article on RAPS.org

Biosimilars: FDA finalizes supplement classification guidance (published 09-Sep-2025)
Read Article on RAPS.org

FDA issues guidance on non-opioid drug development for chronic pain (published 10-Sep-2025)
Read Article on RAPS.org

FDA cracks down on drugs ads, promises to end adequate provision ‘loophole’ (published 10-Sep-2025
Read Article on RAPS.org

Industry suggests changes to FDA’s CMC readiness pilot (published 11-Sep-2025)
Read Article on RAPS.org

FDA finalizes guidance on alternative inspection tools (published 12-Sep-2025)
Read Article on RAPS.org

FDA researchers find promise in custom medical queries to identify safety signals (published 15-Sep-2025 )
Read Article on RAPS.org

ICH adopts M14 guideline on observational studies (published 15-Sep-2025)
Read Article on RAPS.org

FDA issues draft guidances targeting GERD-related conditions (published 16-Sep-2025)
Read Article on RAPS.org

FDA posts more than 100 warning and untitled letters in ad crackdown (published 16-Sep-2025)
Read Article on RAPS.org

Stakeholders seek clarity from FDA on cancer drug combo guidance (published 17-Sep-2025)
Read Article on RAPS.org

FDA proposes guidance for developing drugs for disseminated coccidioidomycosis (published 18-Sep-2025)
Read Article on RAPS.org

Safety labeling: FDA proposes updated guidance on postmarket changes (published 18-Sep-2025)
Read Article on RAPS.org

TRIALSCOPE: Using AI to scale real-world data (published 22-Sep-2025)
Read Article on RAPS.org

FDA finalizes guidance on approval of IVDs during public health emergencies (published 22-Sep-2025)
Read Article on RAPS.org

Experts recommend increased visibility for regulatory analysis of primary clinical trial data (published 22-Sep-2025)
Read Article on RAPS.org

Janssen’s Korean facility cited for GMP violations (published 23-Sep-2025)
Read Article on RAPS.org

Gottlieb calls for FDA reform, investment to counter Chinese medical innovation (published 23-Sep-2025)
Read Article on RAPS.org

FDA finalizes device production and quality system software guidance (published 23-Sep-2025)
Read Article on RAPS.org

ICH adopts E2D(R1) guideline on post-approval safety data (published 24-Sep-2025)
Read Article on RAPS.org

FDA issues guidances on CGT, regenerative medicine development (published 25-Sep-2025)
Read Article on RAPS.org

EU regulators set targets to promote European clinical trials (published 25-Sep-2025)
Read Article on RAPS.org

FDA official updates on advancing RWE program, lists common reasons for rejection (published 25-Sep-2025)
Read Article on RAPS.org

FDA official: Clinical, CMC teams should be on the same page when developing CGTs (published 26-Sep-2025)
Read Article on RAPS.org

EMA tells sponsors to incorporate patient experience across product lifecycle (published 29-Sep-2025)
Read Article on RAPS.org

• Article: FDA Delays Push Biotech Companies to Rethink U.S. Drug Development Strategy
• Webinar Presentation: Selecting the Right Oncology CRO Partner
• Blog: Bayesian Study Designs in Early-Phase Oncology Trials

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.