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This August 2026 regulatory update focuses on the FDA finalizing three guidances addressing formal sponsor meetings, cell and gene therapy development, and therapeutic-equivalence evaluations, while issuing draft guidance on container-closure systems, ANDA versus 505(b)(2) applications, and immunotherapy potency assessments. August RAPS regulatory news focused on manufacturing and quality oversight, quantitative medicine, CMC digitization, reduced animal testing, rare-disease evidence, regulatory pathways, and GMP compliance. FDA also approved 11 products, including five priority-reviewed new molecular entities. Finally, Vaccines Advisory Committee meeting is scheduled for 01Oct26.
FDA Final Guidance:
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products (Published 12-Aug-2026) | Download FDA Guidance
Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products (Published 19-Aug-2026) | Download FDA Guidance
Evaluation of Therapeutic Equivalence (Published 21-Aug-2026) | Download FDA Guidance
FDA Draft Guidance:
Container Closure Systems for Human Drugs and Biological Products (Published 13-Aug-2026) | Draft FDA Guidance
Determining Whether to Submit an ANDA or a 505(b)(2) Application (Published 17-Aug-2026) | Draft FDA Guidance
Potency Assessment of Active Immunotherapy Products (Published 19-Aug-2026) | Draft FDA Guidance
Monthly FDA Approvals
Approval Date: 08/05/2026
Drug Name: ORZEYFULNDA #220860
Active Ingredients: OVEPOREXTON
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: TAKEDA PHARMS USA
Approval Date: 08/09/2026
Drug Name: NITROUS OXIDE, USPNDA #221892
Active Ingredients: NITROUS OXIDE
Submission Classification*:
Review Priority**: Unknown
Company: LINDE GAS EQUIP
Approval Date: 08/13/2026
Drug Name: TAUKLARIFYNDA #220496
Active Ingredients: FLORQUINITAU F-18
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Standard
Company: CERVEAU LANTHEUS
Approval Date: 08/13/2026
Drug Name: ZENBEXUSNDA #221075
Active Ingredients: IBERDOMIDE HYDROCHLORIDE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: BRISTOL MYERS SQUIBB
Approval Date: 08/14/2026
Drug Name: SODIUM BICARBONATENDA #218524
Active Ingredients: SODIUM BICARBONATE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: BAXTER HLTHCARE CORP
Approval Date: 08/17/2026
Drug Name: SEHIPPYNDA #218328
Active Ingredients: VORTIOXETINE
Submission Classification*: Type 2 - New Active Ingredient and Type 3 - New Dosage Form
Review Priority**: Standard
Company: SEASONS BIOTECHNOLOGY (TAIZHOU) CO LTD
Approval Date: 08/19/2026
Drug Name: PASATRUBLA #761508
Active Ingredients: GARETOSMAB-GRTS
Submission Classification*:
Review Priority**:
Company: REGENERON PHARMACEUTICALS, INC
Approval Date: 08/26/2026
Drug Name: VOBRIGNDA #213225
Active Ingredients: LEUPROLIDE ACETATE
Submission Classification*: Type 5 - New Formulation or New Manufacturer
Review Priority**: Standard
Company: SUN PHARM
Approval Date: 08/26/2026
Drug Name: RASONQUENDA #220910
Active Ingredients: DARAXONRASIB
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: REVOLUTION MEDICINES
Approval Date: 08/27/2026
Drug Name: LISRAYANDA #220106
Active Ingredients: BREPOCITINIB TOSYLATE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: PRIOVANT THERAP
Approval Date: 08/27/2026
Drug Name: BIXLENVONDA #221104
Active Ingredients: BICTEGRAVIR SODIUM; LENACAPAVIR SODIUM
Submission Classification*: Type 4 - New Combination
Review Priority**: Priority
Company: GILEAD SCIENCES INC
Approval Date: 08/27/2026
Drug Name: BIXLENVO SUNLENCA STARTER PACK (COPACKAGED)NDA #221443
Active Ingredients: BICTEGRAVIR SODIUM, LENACAPAVIR SODIUM; LENACAPAVIR SODIUM
Submission Classification*: Type 4 - New Combination
Review Priority**: Standard
Company: GILEAD SCIENCES INC
Approval Date: 08/28/2026
Drug Name: MIMRYLONDA #220605
Active Ingredients: RUSFERTIDE ACETATE
Submission Classification*: Type 1 - New Molecular Entity
Review Priority**: Priority
Company: TAKEDA PHARMS AM
Upcoming Advisory Board Meetings
01-Oct-2026: Vaccines and Related Biological Products Advisory Meeting- 09:00 AM EDT- 01:00 PM EDT
Expert sees shift to ecosystem-centric assurance under FDAs distributed manufacturing rule (Published 03-Aug-2026) | Read article on RAPS.org
FDA updates TDS guidances on adhesive performance, skin irritation and sensitization studies (Published 03-Aug-2026) | Read article on RAPS.org
FDA seeks feedback on quantitative medicine network (Published 04-Aug-2026) | Read article on RAPS.org
EMA issues updated guidance on shortage prevention plans ahead of legal deadline (Published 07-Aug-2026) | Read article on RAPS.org
FDA finalizes guidance on formal meetings with drug and biologics sponsors (Published 14-Aug-2026) | Read article on RAPS.org
Experts propose safety framework for improving predictability, interpretation of CNS toxicity (Published 17-Aug-2026) | Read article on RAPS.org
FDA issues draft guidance on assessing container and closure systems for drugs and biologics (Published 17-Aug-2026) | Read article on RAPS.org
Sai Bhamidipati on the new era of digitizing CMC (Published 18-Aug-2026) | Read article on RAPS.org
Stakeholders call for flexibility in guidance aimed at reducing animal testing for cancer drugs (Published 18-Aug-2026) | Read article on RAPS.org
Study highlights difficulty of measuring non-clinical factors that could influence FDA drug approval decisions (Published 18-Aug-2026) | Read article on RAPS.org
FDA issues draft guidance clarifying differences between ANDAs and 505(b)(2) applications (Published 18-Aug-2026) | Read article on RAPS.org
Experts discusses need to modernize evidentiary models in rare diseases (Published 20-Aug-2026) | Read article on RAPS.org
FDA finalizes Q&A guidance on developing cell and gene therapies (Published 20-Aug-2026) | Read article on RAPS.org
Why documentation failures increase audit risk and weaken confidence in your quality processes (Published 24-Aug-2026) | Read article on RAPS.org
Marina Daineko on exploring femtech and other understudied populations (Published 24-Aug-2026) | Read article on RAPS.org
Therapeutic equivalence: FDA finalizes guidance on TE evaluations (Published 24-Aug-2026) | Read article on RAPS.org
FDA warns drugmakers in India, China and the US for GMP issues (Published 25-Aug-2026) | Read article on RAPS.org
FDA drafts guidance on assessing potency of immunotherapy products (Published 25-Aug-26) | Read article on RAPS.org
Pharmaceutical groups raise questions about FDAs expedited IND pilot (Published 26-Aug-26) | Read article on RAPS.org
FDA review details use of manufacturing process models in drug applications (Published 27-Aug-26) | 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.