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Members-only Articles
Validating Recombinant Endotoxin Reagents
Bridging the Gap to Patients
Setting the Standard
Reigniting PDA Puerto Rico
Navigating the AI Landscape
Understanding FDA Complete Response Letters
On The Issue: IPM Microbiology, A Talk with the Editors
Driving Innovation in Pharma
Building Maturity and Resilience Through Quality Culture
A New Era for the PDA Journal
PDA Capital Area Chapter Roundtable on Complete Response Letters Draws a Large Sunday PM Audience
News Brief: FDA Unveils New Tools to Evaluate Drug Manufacturing Sites
HEPA Filter Management—Industry Survey Results
MHRA’s Decentralized Manufacturing Regulation Set to Take Effect
Accelerating Progress: How PDA Drives AI Innovation in Healthcare
Managing Ready-to-Use (RTU) Containers in Aseptic Production Facilities
News Brief: FDA Launches Pilot Program to Boost U.S. Generic Drug Production
From Warp Speed to Uncertainty: U.S. Vaccine Policy in Crisis
Community News Quarterly | October 2025
The New Normal at the FDA
Three Sterility-Enhancing Technologies for Aseptic Life-Science Processes
News Brief: FDA Cracks Down on Misleading Drug Ads
Teaching the Plant
FDA Expands Use of Unannounced Foreign Inspections
Who Picked That Supplier?
The PDA Regulatory Conference Features Over 30 FDA Experts on the Agenda
Beyond the Limits
News Brief: FDA Announed FDA PreCheck
News Brief: PDA AI Glossary Now Available
Supply Challenges and Future Technologies in 2025
EU GMP Annex 1. Implementation of Contamination Control Strategy
Disruption Potential of Injectable Anti-Obesity Therapies and Beyond
News Brief: U.S. FDA Head Makary Says Severity of FDA Layoff Overstated
News Brief: Sean Keveney Appointed Chief Counsel of FDA
Equivalence Testing of BFPCs in Grade A Environments
Community News Quarterly | July 2025
Harnessing HACCP for Aseptic Filling
News Brief: FDA Appoints Dr. George Tidmarsh as Director of CDER
Disruptive Innovations Shaping the GLP-1 Landscape
News Brief: FDA Releases 200 Drug Rejection Letters
Facilitating Adoption of Modern Microbial Methods
Managing Talent Risk in Emerging Cell and Gene Therapy Biotechs
Planning for a Dual-Method Future
News Brief: FDA Finalizes Guidance on Remote Regulatory Assessments
News Brief: FDA Issues Draft ICH Stability Guideline for Public Comment
Beyond the Vial
Leading the Turnaround
Effective AI Deployment in Drug Manufacturing
News Brief: U.S. FDA Launches Commissioner’s National Priority Voucher (CNPV) Program
Alternative Method Audit Preparation
Leadership, Layoffs, and Legislation
News Brief: U.S. FDA Launches AI Tool, Elsa
Engineering Excellence in Container Closure Integrity Testing
News Brief: AI and Reshoring Topic of One-Day DC Event
PDA Europe and EMA Unite
The mRNA Revolution
PDA Spotlight: The Power of Networking and Innovating
Bridging Academia and Industry
News Brief: Successful AI Pilot Prompts FDA to Launch Full-Scale Integration
News Brief: EMA and HMA Joint Workplan on Data and AI in Medicines Regulation
The Need for Manufacturing Speed
News Brief: President Trump Plans Actions to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
PDA Puerto Rico Chapter Reignites
Microneedle Array Patches for Vaccine Delivery
News Brief: FDA/CDER Accepting QMM Prototype Assessment Requests Until June 9
Community News Quarterly | April 2025
News Brief: U.S. FDA Announces Limits to Industry Employees Serving on FDA Advisory Committees
News Brief: Dept. Commerce Seeks Comment on Pharma Import Risks
Expert Perspectives in KM Between Sponsors and Third Parties
Get Ecstatic for Aseptic
Bioburden Monitoring for Primary-Packaging Sterile Manufacturing
Nominations for PDA Board of Directors Open until May 1
Ethical Dilemmas in Pharma: Pharma's Toughest Decisions
Understanding the UK’s International Recognition Procedure
What is the Best Way to Control Contamination on the Hands?
Challenges in Sterilizing Indirect Product-Contact Surfaces
Global Regulatory Convergence — What If?
Bridging the Gap Between Employers and Early Career Professionals to Succeed Together
Knowledge Management and its Relation to Data Integrity
From Lab to Market
Embracing Change: Catalysts for Disruption
Key Steps to Commercialization Readiness in Europe
Uncovering the Symbiotic Link Between KM and AI
Advancing the Industry Dialogue on KM in Support of PQS Effectiveness
PDA to Launch First-of-its-Kind Ethics Course on Pharma Manufacturing
Shaping the Future of Injectable Medicine Inspection
Five Important Insights from the PDA Europe Annex 1 Event
Benefits and Opportunities of Using the PDA AI Glossary
GMP Annex 1 Implementation
The 2025 Kilmer Conference
Parenteral Packaging Conference Explores Transformative Change
Community News Quarterly | January 2025
News Brief: FDA CDER Director Patrizia Cavazzoni Announces Resignation
News Brief: More FDA Guidances for the New Year
News Brief: FDA Releases Draft Guidance on 21 CFR 211.110 Compliance
Modern Microbial Methods Supporting a Contamination Control Strategy
Points to Consider When Applying QRM
How AI and ML Is Getting Integrated into Life Sciences Companies
Biopharmaceutical Manufacturing Conference
