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

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

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News Brief: FDA Issues Draft Guidance Updating Quality Standards for Global Drug Registration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

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

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

Justin Johnson, PDA

Understanding FDA Complete Response Letters

Justin Johnson, PDA

Building Maturity and Resilience Through Quality Culture

Annette Boland, PharmaLex

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

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

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

News Brief: FDA Announced 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

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

Effective AI Deployment in Drug Manufacturing

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