July 23, 2026 Meeting of the Pharmacy Compounding Advisory Committee (PCAC)

On July 23, 2026, the Committee will discuss the following bulk drug substances being considered for inclusion on the 503A Bulks List: BPC-157-related bulk drug substances (BPC-157 (free base)/ BPC-157 acetate), KPV-related bulk drug substances (KPV (free base)/ KPV acetate), TB-500-related bulk drug substances (TB-500 (free base)/ TB-500 acetate), and MOTs-C-related bulk drug substances (MOTs-C (free base)/ MOTs-C acetate).

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July 24, 2026 Meeting of the Pharmacy Compounding Advisory Committee (PCAC)
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July 24, 2026 Meeting of the Pharmacy Compounding Advisory Committee (PCAC)

Cell Therapies and Tissue-Based Products: Generating Scientific Evidence to Facilitate Development
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Cell Therapies and Tissue-Based Products: Generating Scientific Evidence to Facilitate Development

OTP Town Hall: Best Practices for Regulatory Interactions with OTP
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OTP Town Hall: Best Practices for Regulatory Interactions with OTP

AGDD 2025 | D2S03 - Common Deficiencies and Resolutions: Complex Drug Substance/Excipients/Products
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AGDD 2025 | D2S03 - Common Deficiencies and Resolutions: Complex Drug Substance/Excipients/Products

Commissioner’s National Priority Voucher (CNPV) Pilot Program Public Hearing
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Commissioner’s National Priority Voucher (CNPV) Pilot Program Public Hearing

193rd Vaccines and Related Biological Products Advisory Committee Meeting
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193rd Vaccines and Related Biological Products Advisory Committee Meeting

AGDD 2025 | D1S02 - Novel Bioequivalence Study Design Recommendations
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AGDD 2025 | D1S02 - Novel Bioequivalence Study Design Recommendations

FDA’s Dosage and Administration Section of Labeling Draft Guidance Day 1
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FDA’s Dosage and Administration Section of Labeling Draft Guidance Day 1

OTP Town Hall: Cell Therapy CMC Readiness for Late-Stage INDs
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OTP Town Hall: Cell Therapy CMC Readiness for Late-Stage INDs

Conversations on Cancer: Religious Literacy and Spiritual Care for Patients and Caregivers
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Conversations on Cancer: Religious Literacy and Spiritual Care for Patients and Caregivers

Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers
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Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers

FDA Webinar: Safety Assessment of Genome Editing in Gene Therapy
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FDA Webinar: Safety Assessment of Genome Editing in Gene Therapy

OTC Monograph Drug User Fee Amendments (OMUFA): FY 2026 User Fees and Registration
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OTC Monograph Drug User Fee Amendments (OMUFA): FY 2026 User Fees and Registration

AGDD 2025 | D2S04 - Nitrosamines: Known Issues and Practical Advice
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AGDD 2025 | D2S04 - Nitrosamines: Known Issues and Practical Advice

FDA Grand Rounds: FDA Menopausal Hormone Therapy (MHT) Labeling: Historical Context & Recent Changes
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FDA Grand Rounds: FDA Menopausal Hormone Therapy (MHT) Labeling: Historical Context & Recent Changes

Office of New Drugs Standard Safety Tables and Figures for New Drug and Biologic Applications
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Office of New Drugs Standard Safety Tables and Figures for New Drug and Biologic Applications

AGDD 2025 | D2S05 - Workshop Closing Remarks
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AGDD 2025 | D2S05 - Workshop Closing Remarks

Financial Transparency & Efficiency of the Prescription Drug, Biosimilar, & Generic Drug User Fees
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Financial Transparency & Efficiency of the Prescription Drug, Biosimilar, & Generic Drug User Fees

CMC Flexibilities for Developing Human Cell and Gene Therapy Products for a BLA
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CMC Flexibilities for Developing Human Cell and Gene Therapy Products for a BLA

FDA Grand Rounds: Shigatoxigenic E. coli in Central Coast CA Agriculture
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FDA Grand Rounds: Shigatoxigenic E. coli in Central Coast CA Agriculture