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Quality and Regulatory

Setting the Standard

Katharina Schlereth, Labor LS

Reigniting PDA Puerto Rico

Justin Johnson, PDA

Navigating the AI Landscape

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

Understanding FDA Complete Response Letters

Justin Johnson, PDA

Driving Innovation in Pharma

Antonella Maggio, Lesirg Consultants Inc. , Beth Haas, Haas Pharma Consulting LLC , and Vinny Browning III, Amgen, Inc.

Building Maturity and Resilience Through Quality Culture

Annette Boland, PharmaLex

A New Era for the PDA Journal

PDA JPST Editorial Team

PDA Capital Area Chapter Roundtable on Complete Response Letters Draws a Large Sunday PM Audience

Walter Morris, PDA

News Brief: FDA Unveils New Tools to Evaluate Drug Manufacturing Sites

Justin Johnson, PDA

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.

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, Eli Lilly

News Brief: FDA Cracks Down on Misleading Drug Ads

Justin Johnson, PDA

Teaching the Plant

Abhinav Arora, Curia

FDA Expands Use of Unannounced Foreign Inspections

Louise Uí Fhatharta, Pharmalex

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

News Brief: U.S. FDA Head Makary Says Severity of FDA Layoff Overstated

Walter Morris, PDA

News Brief: Sean Keveney Appointed Chief Counsel of FDA

Justin Johnson, PDA

Equivalence Testing of BFPCs in Grade A Environments

Mads Lichtenberg, PhD, Fujifilm Biotechnologies, et. al.

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

Walter Morris, PDA

News Brief: FDA Releases 200 Drug Rejection Letters

Justin Johnson, PDA

Planning for a Dual-Method Future

Nora Blair, Charles River

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

Leading the Turnaround

Troy Chavis, PrecisionPharma Manufacturing Solutions, LLC