PDA Letter

Features | AI-Powered Drug Discovery & Development

The AI Revolution in Drug Discovery

Niravbhai Patel, PhD, Nivagen Pharmaceuticals, Inc.

Using ATP Bioluminescence to Support Clinical In-Use Hold Times

Sophie Drinkwater, AstraZeneca, et al.

Addressing Challenges in Technology Transfer for Early-Phase Cell and Gene Therapy Products

Gurinderpal Singh

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Aseptic Processing & Sterilization

Using ATP Bioluminescence to Support Clinical In-Use Hold Times

Sophie Drinkwater, AstraZeneca, et al.

Sterile Manufacturing Under Stress

Anya Hillery, PhD, Freelance Medical Writer

Three Technologies Boosting Sterility Assurance in Life-Science Aseptic Processes

PDA Staff Author: David Jaworski, MBA

Optimizing Cleanroom Disinfection

Karan Khairnar, MS

Preventing Condensation in Cleanrooms

Tony Cundell, PhD

Setting the Standard

Katharina Schlereth

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Biopharmaceuticals & Biotechnology

The AI Revolution in Drug Discovery

Niravbhai Patel, PhD

News Brief: FDA Expands AI with Agentic Deployment

Justin Johnson, PDA

Navigating the AI Landscape

Peter Makowenskyj, MEng Toni Manzano

Driving Innovation in Pharma

Antonella Maggio Beth Haas Vinny Browning III

Accelerating Progress: How PDA Drives AI Innovation in Healthcare

Andrew Chang, Novo Nordisk, et al.

From Warp Speed to Uncertainty: U.S. Vaccine Policy in Crisis

Anya Hillery, PhD, Freelance Medical Writer

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Manufacturing Science

The Production of Suitable Inoculums for Microbial Tests

Tony Cundell, PhD

Addressing Challenges in Technology Transfer for Early-Phase Cell and Gene Therapy Products

Gurinderpal Singh

Building a Business Case for a New LIMS

Justin Lavimodiere

MHRA’s Decentralized Manufacturing Regulation Set to Take Effect

Munyaradzi Japondo

Teaching the Plant

Abhinav Arora

Beyond the Limits

Yanet Flor

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People

News Brief: FDA Seeks Removal of Suicidal Behavior Warning for GLP-1 RA Medications

Justin Johnson, PDA

On The Issue: Cristiana Campa Discusses Second Edition of Bestselling QbD Book

PDA

Students Step Beyond the Classroom

Tita Tavares, PDA

On The Issue: Marcia Baroni Discusses Newly Released TR-22

PDA

Reigniting PDA Puerto Rico

Justin Johnson, PDA

On The Issue: IPM Microbiology, A Talk with the Editors

PDA

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Quality and Regulatory

QSIT: Another Regulatory Acronym Bites the Dust

Walt Morris, PDA

Overcoming the Challenges of Metrics Implementation

Denyse Baker Adam Caruso Mary Howe Richard Love

Harnessing AI to Strengthen Audit Readiness in Pharmaceutical Manufacturing

Abhinav Arora

From Theoretical Sensitivity to Proven Detection Capability

Oliver Stauffer Patrick Dayton

News Brief: FDA Begins Accepting Manufacturing PreCheck Applications

Walter Morris, PDA

News Brief: FDA Issues Draft Guidance Updating Quality Standards for Global Drug Registration

Justin Johnson, PDA

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Supply Chain and Outsourcing

News Brief: FDA Launches Pilot Program to Boost U.S. Generic Drug Production

Justin Johnson, PDA

Who Picked That Supplier?

Dr. Jane Zhang Nazifa Rahman Anna Schniepp

Supply Challenges and Future Technologies in 2025

Deirdre Tobin Connie Leech

PDA Manufacturing Meets Legislation

Dr. Bettine Boltres Ana Marques Kuschel, PhD

The High Cost of Cheap Drugs

Martin VanTrieste

A Comprehensive Review of Regulatory Intelligence: Exploring Tools and Program Maturities

Jason Kerr Katie Bevard Maria Jacobs, PhD, Pfizer, Inc.

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PDA Letter's Top Articles

Sterile Manufacturing Under Stress

Anya Hillery, PhD, Freelance Medical Writer

Three Technologies Boosting Sterility Assurance in Life-Science Aseptic Processes

PDA Staff Author: David Jaworski, MBA

Optimizing Cleanroom Disinfection

Karan Khairnar, MS, Ecolab Life Sciences

Setting the Standard

Katharina Schlereth, Labor LS

EU GMP Annex 1. Implementation of Contamination Control Strategy

Anne Moreau, GSK Vacccines

Recent Articles (Past 60 Days)

QSIT: Another Regulatory Acronym Bites the Dust

Walt Morris, PDA
Overcoming the Challenges of Metrics Implementation

Denyse Baker, Eli Lilly and Company , Adam Caruso, Merck & Co., Inc. , Mary Howe, Bristol Myers Squibb , and Richard Love, HarborView LLC

The AI Revolution in Drug Discovery

Niravbhai Patel, PhD, Nivagen Pharmaceuticals, Inc.

Harnessing AI to Strengthen Audit Readiness in Pharmaceutical Manufacturing

Abhinav Arora, ReveonAI Lifesciences

From Theoretical Sensitivity to Proven Detection Capability

Oliver Stauffer, PTI and Patrick Dayton, PTI

Using ATP Bioluminescence to Support Clinical In-Use Hold Times

Sophie Drinkwater, AstraZeneca, et al.
News Brief: FDA Begins Accepting Manufacturing PreCheck Applications

Walter Morris, PDA
News Brief: FDA Issues Draft Guidance Updating Quality Standards for Global Drug Registration

Justin Johnson, PDA
The Production of Suitable Inoculums for Microbial Tests

Tony Cundell, PhD, Microbiological Consulting, LLC

Addressing Challenges in Technology Transfer for Early-Phase Cell and Gene Therapy Products

Gurinderpal Singh, GSK

News Brief: EMA and FDA Unite on AI Principles to Revolutionize Medicine Development

Justin Johnson, PDA

Quality & Regulatory
News Brief: FDA Seeks Removal of Suicidal Behavior Warning for GLP-1 RA Medications

Justin Johnson, PDA
Ensuring Data Integrity in Pharmaceutical Microbiology Laboratories

Miriam Guest, Charles River Laboratories

Building a Business Case for a New LIMS

Justin Lavimodiere, Veeva LIMS

Sterile Manufacturing Under Stress

Anya Hillery, PhD, Freelance Medical Writer

News Brief: FDA Explores New Contracting Model to Boost Public Health Innovation

Justin Johnson, PDA