FDA

Trends

FDA Increased For-Cause Inspections Almost 250% in 2025

November 12, 2025

Trends

Non-Sterile Doesn’t Mean Low Risk: FDA Emphasizes Gaps in Microbial Control

October 27, 2025

Conference Spotlight

FDA: A Pillar of Protection for Patients and Industry

April 4, 2025

Enforcement

Limiting Plant Access and Sharing Redacted Documents Results in Import Alert and Warning Letter

January 28, 2025

Biologics Inspection Case Studies Highlight API and Drug Product Deficiencies

December 9, 2024

FDA Inspection Database: An Essential Tool to Prepare for FDA Inspections

November 29, 2024

Trends

MedTech 2024 Highlights: A Look at iCGM Systems and CPAP Machines

November 25, 2024

Trends

Using CGMP Site Risk Scores to Predict Drug Shortages

November 22, 2024

Addressing FDA’s Biggest Challenges

November 15, 2024

Conference Spotlight

Who is Responsible When GMPs Are Not Followed?

October 9, 2024

Enforcement

Comprehensive Guide to 21 CFR 820.30 for MedTech

October 8, 2024

Conference Spotlight

What is a VAI or OAI Regulatory Meeting?

October 2, 2024

Conference Spotlight

FDA Investigator Attrition Rate Addressed at 2024 PDA/FDA Conference

September 11, 2024

Conference Spotlight

A Glimpse into the Thought Processes of an FDA Expert Investigator

August 28, 2024

Conference Spotlight

We Received a 483 After an FDA Inspection – Now What?

May 23, 2024

Conference Spotlight

How AI Can Reveal Enforcement Trends in Data Integrity

April 25, 2024

Conference Spotlight

Antibiotic-Resistant Bacteria in Patients Is a Genetic Match to Product Contaminant

April 19, 2024

What Is Quality Intelligence? How is Data Governance a Key Enabler?

January 16, 2024

Farewell FDAzilla.com

January 8, 2024

Avoiding the Trap of a Data Swamp

November 28, 2023

Conference Spotlight

Drug GMP Warning Letter Issued Without Facility Inspection

November 20, 2023

At GMP by the Sea, Redica Systems Corroborates FDA Example on the Spot

November 8, 2023

Conference Spotlight

FDA Post-Warning Letter Meetings are Not Agency Consultations

September 25, 2023

Trends

How Redica Systems Goes Further than the FDA Data Dashboard

August 21, 2023

Audience Q&A: From Legal Considerations when Interacting with the FDA Webinar

August 10, 2023

Legal Advice for Before, During, and After an FDA Inspection

July 25, 2023

Enforcement

Internal Audit Reports: Can the FDA Take a Peek? Part 2: Other Agencies

July 18, 2023

Enforcement

Expert Commentary | Updates to FDA’s Manual of Policies and Procedures (MAPP)

July 12, 2023

Enforcement

Expert Commentary: FY2022 Report on the State of Pharmaceutical Quality

June 29, 2023

Conference Spotlight

A Deep Dive into Cell and Gene Therapy Regulatory Considerations: Part Two

May 25, 2023

Enforcement

Internal Audit Reports: Can the FDA Take a Peek?

April 19, 2023

What Are Inferred CFR Codes?

February 24, 2023

Conference Spotlight

FDA on the Evolution of Biologics Inspections: Part III

January 26, 2023

Conference Spotlight

FDA on the Evolution of Biologics Inspections: Part II

December 6, 2022

Conference Spotlight

FDA on the Evolution of Biologics Inspections: Part I

November 28, 2022

Conference Spotlight

Persistent Non-Compliance Leads to a Consent Decree

October 27, 2022

All tags