PDA Letter

Aseptic Processing & Sterilization

Harnessing HACCP for Aseptic Filling

Abu Sadat Muhammod Saiyem, Square Pharmacuetical Limited

Get Ecstatic for Aseptic

David Keen, Ecolab Life Sciences

Biopharmaceuticals & Biotechnology

Disruptive Innovations Shaping the GLP-1 Landscape

Anya Hillery, PhD, Freelance Medical Writer

The mRNA Revolution

Amisha Patel, Sanofi

Manufacturing Science

From Lab to Market

Tejesh Marsale, PCI Pharma Services

Five Important Insights from the PDA Europe Annex 1 Event

Patrick Nieuwenhuizen, PharmaLex

GMP Annex 1 Implementation

Andrea Salmaso, Stevanato Group

People

Quality and Regulatory

Harnessing HACCP for Aseptic Filling

Abu Sadat Muhammod Saiyem, Square Pharmacuetical Limited

Disruptive Innovations Shaping the GLP-1 Landscape

Anya Hillery, PhD, Freelance Medical Writer

News Brief: FDA Releases 200 Drug Rejection Letters

Justin Johnson, PDA

Supply Chain and Outsourcing

The mRNA Revolution

Amisha Patel, Sanofi

PDA Manufacturing Meets Legislation

Dr. Bettine Boltres and Ana Marques Kuschel, PhD, WEST Pharmaceutical Services

The High Cost of Cheap Drugs

Martin VanTrieste, Civica Rx

PDA Letter's Top Articles

Recent Articles (Past 60 Days)

Community News Quarterly | July 2025

PDA

Harnessing HACCP for Aseptic Filling

Abu Sadat Muhammod Saiyem, Square Pharmacuetical Limited

News Brief: FDA Appoints Dr. George Tidmarsh as Director of CDER

Walter Morris, PDA

Disruptive Innovations Shaping the GLP-1 Landscape

Anya Hillery, PhD, Freelance Medical Writer

News Brief: FDA Releases 200 Drug Rejection Letters

Justin Johnson, PDA

Facilitating Adoption of Modern Microbial Methods

Allison Scott, BWT Pharma & Biotech Inc, et al.

Managing Talent Risk in Emerging Cell and Gene Therapy Biotechs

Tamer Helmy, PhD, Molecular Templates

Planning for a Dual-Method Future

Nora Blair, Charles River

Enhancing Consistency in Environmental Monitoring: Addressing Variability in Surface Sampling

Vanessa Figueroa, VVF Science and Josh Erickson, M.S., US Pharmacopeia

News Brief: FDA Finalizes Guidance on Remote Regulatory Assessments

Justin Johnson, PDA

News Brief: FDA Issues Draft ICH Stability Guideline for Public Comment

Walter Morris, PDA

Beyond the Vial

Philippe Lauwers, Terumo Pharmaceutical Solutions and Coralie Richard, Eli Lilly and Company

Leading the Turnaround

Troy Chavis, PrecisionPharma Manufacturing Solutions, LLC

Effective AI Deployment in Drug Manufacturing

Peter Makowenskyj, MEng, G-CON Manufacturing and Toni Manzano, PhD, Aizon

News Brief: U.S. FDA Launches Commissioner’s National Priority Voucher (CNPV) Program

Walt Morris, PDA

Alternative Method Audit Preparation

Jon Kallay, Charles River Laboratories, et. al.

Leadership, Layoffs, and Legislation

Katie Bevard, Eli Lilly

News Brief: U.S. FDA Launches AI Tool, Elsa

Justin Johnson, PDA

Engineering Excellence in Container Closure Integrity Testing

Oliver Stauffer, PTI