PDA Letter

Features | Grade A Perspectives

Managing Ready-to-Use (RTU) Containers in Aseptic Production Facilities

Alliance for RTU and IMA Life

Three Sterility-Enhancing Technologies for Aseptic Life-Science Processes

David Jaworski, MBA

Sponsored by Kindeva

Bridging the Gap to Patients

Tommy Schornak

Previously Featured Articles

Aseptic Processing & Sterilization

Managing Ready-to-Use (RTU) Containers in Aseptic Production Facilities

Alliance for RTU and IMA Life

Three Sterility-Enhancing Technologies for Aseptic Life-Science Processes

PDA Staff Author: David Jaworski, MBA

Harnessing HACCP for Aseptic Filling

Abu Sadat Muhammod Saiyem

Get Ecstatic for Aseptic

David Keen

What is the Best Way to Control Contamination on the Hands?

PDA Staff Author: David Jaworski, MBA

Challenges in Sterilizing Indirect Product-Contact Surfaces

Cecilia Pierobon

More Articles

Biopharmaceuticals & Biotechnology

Disruption Potential of Injectable Anti-Obesity Therapies and Beyond

Mathias Romacker

Disruptive Innovations Shaping the GLP-1 Landscape

Anya Hillery, PhD, Freelance Medical Writer

The Need for Manufacturing Speed

Michael Anyadiegwu, PhD Renske Hesselink, PhD Ingrid Kromann

Breaking point: Assessing and Addressing the Risk of Auto-Injector Failure

Enrico Barichello

Microbial Ingress No Longer an Effective CCI Test Method

Oliver Stauffer Tyler Harris

PDA Manufacturing Meets Legislation

Dr. Bettine Boltres Ana Marques Kuschel, PhD

More Articles

Manufacturing Science

Sponsored by Kindeva

Bridging the Gap to Patients

Tommy Schornak

News Brief: PDA AI Glossary Now Available

Walter Morris, PDA

EU GMP Annex 1. Implementation of Contamination Control Strategy

Anne Moreau, GSK Vacccines

From Lab to Market

Tejesh Marsale

GMP Annex 1 Implementation

Andrea Salmaso

Breaking point: Assessing and Addressing the Risk of Auto-Injector Failure

Enrico Barichello

More Articles

People

Community News Quarterly | October 2025

PDA

Community News Quarterly | July 2025

PDA

Managing Talent Risk in Emerging Cell and Gene Therapy Biotechs

Tamer Helmy, PhD

Beyond the Vial

Philippe Lauwers Coralie Richard

PDA Spotlight: The Power of Networking and Innovating

PDA

Bridging Academia and Industry

Renee Morley, MBA

More Articles

Quality and Regulatory

MHRA’s Decentralized Manufacturing Regulation Set to Take Effect

Munyaradzi Japondo

Accelerating Progress: How PDA Drives AI Innovation in Healthcare

Andrew Chang, Novo Nordisk, et al.

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

Justin Johnson, PDA

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

Anya Hillery, PhD, Freelance Medical Writer

The New Normal at the FDA

Katie Bevard

News Brief: FDA Cracks Down on Misleading Drug Ads

Justin Johnson, PDA

More Articles

Supply Chain and Outsourcing

Who Picked That Supplier?

Dr. Jane Zhang Nazifa Rahman Anna Schniepp

Supply Challenges and Future Technologies in 2025

Deirdre Tobin Connie Leech

EU GMP Annex 1. Implementation of Contamination Control Strategy

Anne Moreau, GSK Vacccines

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.

More Articles

PDA Letter's Top Articles

The New Normal at the FDA

Katie Bevard, Eli Lilly

Three Sterility-Enhancing Technologies for Aseptic Life-Science Processes

PDA Staff Author: David Jaworski, MBA

FDA Expands Use of Unannounced Foreign Inspections

Louise Uí Fhatharta, Pharmalex

Who Picked That Supplier?

Dr. Jane Zhang, ETCH Sourcing , Nazifa Rahman, ETCH Sourcing , and Anna Schniepp, ETCH Sourcing

Equivalence Testing of BFPCs in Grade A Environments

Mads Lichtenberg, PhD, Fujifilm Biotechnologies, et. al.
Process Hold Times: What is it and Why is it Important?

Robert Dream, MS, Nivagen Pharmaceuticals and Bruce Loxley, GSK

PUPSIT and the Annex 1 Revision

Tina Morris, PDA, Maik Jornitz, G-Con, Gabriele Gori, GSK, and Hal Baseman, ValSource

Recent Articles (Past 60 Days)

Sponsored by Kindeva
Bridging the Gap to Patients

Tommy Schornak, Kindeva

Sponsored by Particle Measuring Systems
Normalized Data in Microbial Continuous Monitoring

Rosa Laronga, Particle Measuring Systems , Giulia Paternò, Particle Measuring Systems , and Serena Steidl, Particle Measuring Systems

MHRA’s Decentralized Manufacturing Regulation Set to Take Effect

Munyaradzi Japondo, PharmaLex

Accelerating Progress: How PDA Drives AI Innovation in Healthcare

Andrew Chang, Novo Nordisk, et al.
Managing Ready-to-Use (RTU) Containers in Aseptic Production Facilities

Alliance for RTU and IMA Life
News Brief: FDA Launches Pilot Program to Boost U.S. Generic Drug Production

Justin Johnson, PDA
From Warp Speed to Uncertainty: U.S. Vaccine Policy in Crisis

Anya Hillery, PhD, Freelance Medical Writer

Community News Quarterly | October 2025

PDA
The New Normal at the FDA

Katie Bevard, Eli Lilly

Three Sterility-Enhancing Technologies for Aseptic Life-Science Processes

PDA Staff Author: David Jaworski, MBA

News Brief: FDA Cracks Down on Misleading Drug Ads

Justin Johnson, PDA
Teaching the Plant

Abhinav Arora

FDA Expands Use of Unannounced Foreign Inspections

Louise Uí Fhatharta, Pharmalex

Who Picked That Supplier?

Dr. Jane Zhang, ETCH Sourcing , Nazifa Rahman, ETCH Sourcing , and Anna Schniepp, ETCH Sourcing

The PDA Regulatory Conference Features Over 30 FDA Experts on the Agenda

Walter Morris, PDA
Beyond the Limits

Yanet Flor, GMP Check Solutions

News Brief: FDA Announed FDA PreCheck

Justin Johnson, PDA
News Brief: PDA AI Glossary Now Available

Walter Morris, PDA
Supply Challenges and Future Technologies in 2025

Deirdre Tobin, Compass Pharma Consulting Ltd and Connie Leech, CAI