Practical guidance on FDA compliance, enforcement trends, and regulatory strategy — written by an RAC-certified consultant who works in the trenches every day.
The FDA regulatory landscape never stands still. New guidance documents, shifting enforcement priorities, evolving inspection protocols, and changing submission requirements create a constant challenge for companies that manufacture, distribute, or import FDA-regulated products. Whether you operate in pharmaceuticals, medical devices, food manufacturing, dietary supplements, or biologics — staying current on FDA developments is not optional. It is a business requirement.
This blog is built for regulatory affairs professionals, quality managers, compliance officers, and business leaders who need practical, actionable FDA intelligence. Every article is written or reviewed by Jared Clark, an RAC-certified FDA consultant with credentials spanning pharmaceutical GMP (CPGP), food safety auditing (CQA), quality management (CMQ-OE), and project management (PMP) — plus the legal perspective that comes with a JD.
You will find in-depth analysis of FDA warning letter trends, step-by-step inspection preparation guides, regulatory pathway comparisons for device and drug submissions, compliance checklists for foreign manufacturers, and strategic frameworks for responding to FDA enforcement actions. Each post connects regulatory requirements to real-world execution — because understanding what the FDA requires is only useful when you know how to implement it.
We cover all five major FDA centers: CDER (drugs), CDRH (medical devices), CFSAN (food and dietary supplements), CBER (biologics), and CVM (veterinary products). Whether your immediate concern is an upcoming FDA inspection, a pending 510(k) submission, a warning letter response deadline, or simply building a more robust compliance program — this blog provides the regulatory insight you need to make informed decisions.
New articles are published regularly. Subscribe below to receive FDA regulatory updates directly in your inbox — no spam, just expert analysis that helps you stay compliant and competitive.
FDA cleared expanded access for daraxonrasib. Here's what the approval means for CGMP, quality systems, and audit readiness at sponsor and CDMO sites.
Learn how supplement claims cross into drug territory under FDA rules, why testimonials are the biggest risk, and how to build a claims review system that holds up.
FDA proposes excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list. Here's what it means for outsourcing facilities and clinics.
FDA cleared Auvelity for dementia-related agitation without an antipsychotic boxed warning. Here's what sponsors and providers need to do next.
FDA hit its Year 1 milestones on reducing animal testing in drug development. Here's what the progress means for your regulatory strategy. Expert analysis inside.
CMS's CY2027 Medicare Advantage & Part D final rule is live. Learn what changed in Star Ratings, marketing, drug coverage, and enrollment — and how to comply.
A single equipment failure at Wawa triggered a recall affecting 123+ stores. Learn the allergen preventive controls, CIP validation protocols, and FSMA requirements that prevent beverage recalls.
Learn the quality systems, pH monitoring, and seal integrity controls that prevent FDA beverage recalls. Expert compliance guidance from Certify Consulting.
FDA filed an IACM petition to remove methylene chloride, trichloroethylene & ethylene dichloride from color additive regs. Learn what this means for your compliance.
The Kian Pee Wan recall found undeclared dexamethasone and cyproheptadine in an herbal supplement. Learn the 21 CFR Part 111 identity testing controls that would have caught it before distribution.
Learn what quality systems, testing protocols, and manufacturing controls prevent FDA recalls from undeclared drug ingredients in dietary supplements. Expert guidance.
Learn what cold chain failures cause Clostridium botulinum recalls in peeled garlic — and the quality systems, testing protocols, and SOPs that prevent them.
Tops Issues Recall of Christopher Ranch Peeled Garlic & Garland Fresh Peeled Garlic Because of Possible Health Risk from C. botulinum. Learn the FSMA preventive controls that would have prevented this April 2026 recall.
Blueroot Health issues voluntary allergy alert on Vital Nutrients Aller-C for undeclared egg, hazelnut, and soy. Learn FALCPA compliance, allergen labeling rules, and 21 CFR Part 117 requirements.
Blueroot Health's Vital Nutrients Aller-C recall reveals critical allergen labeling gaps. Learn the compliance lessons and how to prevent undeclared allergen violations.
Learn what Schreiber Foods' almond allergy recall reveals about FDA labeling compliance. Practical steps to prevent undeclared allergen violations. Contact Certify Consulting.
FDA has delayed the effective date of its spirulina extract color additive expansion. Learn what changed, which foods are affected, and how to stay compliant.
FDA proposes reclassifying TB cell-mediated immunity tests from Class III to Class II. Learn what changed, key deadlines, and how to stay compliant. Guidance inside.
FDA approves Kresladi (marnetegragene autotemcel), the first gene therapy for severe LAD-I. Learn what this approval means for your compliance strategy. Consult Certify Consulting.
A 170-million-unit recall of alcohol prep pads contaminated with a spore-forming bacterium reveals systemic gaps in environmental monitoring, bioburden testing, and CAPA. Here is what manufacturers must fix.
Learn how FDA is regulating AI in drug manufacturing and quality control. Expert analysis of current guidance, GMP expectations, and compliance steps. Get started today.
Understand the FDA's AI/ML framework in 2026. Learn what regulated companies must do now to stay compliant. Expert guidance from Jared Clark, RAC.
Learn FDA's machine learning requirements for drug and device submissions. Understand SaMD, PCCP, and AI/ML frameworks. Get expert guidance from Certify Consulting.
Learn how to distinguish FDA structure-function claims from drug claims, avoid enforcement action, and keep your supplement or food label fully compliant.
Understand the key differences between HARPC and HACCP under FSMA, and what your facility must do to stay compliant. Expert guidance from Certify Consulting.
Learn MedWatch requirements for dietary supplement adverse event reporting. Expert guidance on mandatory vs. voluntary reporting, timelines, and FDA compliance.
Learn how FDA Import Alerts and DWPE work, why products get detained, and how to get removed. Expert guidance from Jared Clark at Certify Consulting.
Understand the critical differences between an FDA 483 observation and a Warning Letter — and learn which is worse, what each means, and how to respond effectively.
Learn what FDA FSMA Preventive Controls your food facility must have in place. Expert guidance on compliance requirements, hazard analysis, and audit readiness.
Learn what FDA consent decrees are, how they're triggered, real-world costs, and proven strategies to avoid them. Expert guidance from Certify Consulting.
Master FDA dietary supplement compliance — cGMP, labeling, NDI notifications, adverse event reporting, and more. Get expert guidance from Certify Consulting.
How to Choose the Right FDA Consultant: What to Look For
Learn exactly how to respond to an FDA Form 483 with a proven timeline, strategy, and response template. Get expert guidance from Certify Consulting.
Learn the key differences between FDA 510(k) and De Novo pathways, when to use each, and how to choose the right route for your medical device. Expert guidance inside.
Complete guide to FDA registration for foreign manufacturers—U.S. agent requirements, facility registration steps, and compliance deadlines. Get expert help today.
Learn how undeclared tadalafil in dietary supplements triggers FDA recalls, criminal liability, and what distributors must do now to stay compliant.
Learn exactly what happens during an FDA inspection — from opening meeting to Form 483. Expert guidance from Certify Consulting to help you pass the first time.
Learn what quality systems, allergen controls, and labeling protocols prevent undeclared wheat and soy recalls. Expert FDA compliance guidance from Certify Consulting.
If you're facing an FDA inspection, responding to a warning letter, or navigating a regulatory submission — schedule a free consultation with Jared Clark, RAC. Expert guidance, no obligation.
Free Download
How to structure the 15-business-day response FDA expects, what to avoid saying, and the 90 days of corrective action that follow — phase by phase, starting the day the letter arrives.
Download the Free Playbook