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Meet Veristat at the ASCO Annual Meeting
May 29 - June 2, 2026 | Chicago, IL
▶️ At the Forefront of Oncology Progress
Veristat is pleased to attend the ASCO...
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This April 2026 regulatory update highlights new policies on biomarker validation, expanded access to investigational drugs, genome editing safety assessments, and antibiotic impurity specifications. It also summarizes major FDA and industry developments such as ongoing GDUFA IV and PDUFA VIII negotiations, increased focus on rare diseases, AI use in drug manufacturing, clinical trial modernization, and post-marketing compliance trends. Additionally, the report lists April 2026 FDA drug approvals and notes an upcoming Pharmacy Compounding Advisory Committee meeting scheduled for July 23–24, 2026.
FDA Final Guidance:
Bioanalytical Method Validation for Biomarkers (published 10-Apr-2026)
Download FDA Guidance
Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers (published 15-Apr-2026)
Download FDA Guidance
FDA Draft Guidance:
Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing (published 14-Apr-2026)
Draft FDA Guidance
Establishing Impurity Specifications for Antibiotics (published 20-Apr-2026)
Draft FDA Guidance
Monthly FDA Approvals
Approval Date: 04/01/2026
Drug Name: FOUNDAYONDA #220934
Active Ingredients: ORFORGLIPRON CALCIUM
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: ELI LILLY AND CO
Approval Date: 04/20/2026
Drug Name: IDVYNSONDA #216964
Active Ingredients: DORAVIRINE; ISLATRAVIR
Submission Classification*: Type 1 - New Molecular Entity and Type 4 - New Combination
Review Priority**: Standard
Company: MSD
Approval Date: 04/24/2026
Drug Name: SAPHNELOBLA #761451
Active Ingredients: ANIFROLIMAB-FNIA
Submission Classification*:
Review Priority**:
Company: ASTRAZENECA AB
Approval Date: 04/29/2026
Drug Name: LANGLARABLA #761412
Active Ingredients: INSULIN GLARGINE-ALDY
Submission Classification*:
Review Priority**:
Company: SUNSHINE LAKE PHARMA CO LTD
Upcoming Advisory Board Meetings
23-Jul-2026/ 24-Jul-2026: Pharmacy Compounding Advisory Committee Meeting- 08:00 AM EDT- 03:50 PM EDT
GDUFA IV: Sticking points emerge as negotiations press on (published 02-Apr-2026)
Read article on RAPS.org
Commenters seek clarity, expansion of multiple myeloma accelerated approval draft guidance (published 03-Apr-2026)
Read article on RAPS.org
Advocacy groups ask FDA to share more information about rare diseases (published 06-Apr-2026)
Read article on RAPS.org
FDA sets October deadline for new safety reporting format (published 06-Apr-2026)
Read article on RAPS.org
FDA budget proposal: New clinical trial pathway; permanent authorization of rare pediatric disease voucher program (published 07-Apr-2026)
Read article on RAPS.org
PDUFA VIII: FDA, industry make significant progress toward agreement (published 08-Apr-2026)
Read article on RAPS.org
Expert: FDA, industry still wary of enrolling patients in early cell and gene therapy trials (published 09-Apr-2026)
Read article on RAPS.org
Study: Most bispecific antibodies lack postapproval improvements to overall survival, quality of life (published 10-Apr-2026)
Read article on RAPS.org
FDA nudges sponsors, researchers to publish trial results (published 13-Apr-2026)
Read article on RAPS.org
Høeg touts FDA efforts to speed rare disease drugs to market (published 14-Apr-2026)
Read article on RAPS.org
FDA drafts guidance on using next-generation sequencing to assess gene therapy safety (published 14-Apr-2026)
Read article on RAPS.org
FDA official: Data quality is key to plausible mechanism framework (published 15-Apr-2026)
Read article on RAPS.org
FDA considers adding a dozen peptides to its bulk drug compounding list (published 16-Apr-2026)
Read article on RAPS.org
FDA asks testosterone therapy firms to seek expanded indication (published 16-Apr-2026)
Read article on RAPS.org
FDA warns firm for inappropriate use of AI in drug manufacturing (published 17-Apr-2026)
Read article on RAPS.org
FDA draft guidance sets impurity controls for most antibiotics (published 20-Apr-2026)
Read article on RAPS.org
FDA finds most postmarketing requirements, commitments progressing on schedule (published 27-Apr-2026)
Read article on RAPS.org
Fewer than half of NIH-funded studies analyze sex differences (published 28-Apr-2026)
Read article on RAPS.org
FDA announces efforts to advance real-time clinical trials (published 29-Apr-2026)
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.
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.