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 (CFSQA), 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.
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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.
Learn what allergen controls, testing protocols, and labeling systems prevent undeclared peanut recalls. Practical FDA compliance guidance for food...
A single equipment failure at Wawa triggered a recall affecting 123+ stores. Learn the allergen preventive controls, CIP validation protocols, and FSMA...
The Kian Pee Wan recall found undeclared dexamethasone and cyproheptadine in an herbal supplement. Learn the 21 CFR Part 111 identity testing controls that...
Tops Issues Recall of Christopher Ranch Peeled Garlic & Garland Fresh Peeled Garlic Because of Possible Health Risk from C. botulinum. Learn the FSMA...
Blueroot Health issues voluntary allergy alert on Vital Nutrients Aller-C for undeclared egg, hazelnut, and soy. Learn FALCPA compliance, allergen labeling...
Learn what quality systems, pesticide testing protocols, and supply chain controls prevent organic food recalls. Prevention-focused FDA compliance guidance...
FDA's final order reclassifies melanoma detection devices from class III to class II. Learn what changed, effective dates, and how to stay compliant. Expert...
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...
FDA approves Kresladi (marnetegragene autotemcel), the first gene therapy for severe LAD-I. Learn what this approval means for your compliance strategy...
A 170-million-unit recall of alcohol prep pads contaminated with a spore-forming bacterium reveals systemic gaps in environmental monitoring, bioburden...
Learn the quality systems, sterility testing, and manufacturing controls that prevent microbial contamination in alcohol prep pads. Expert FDA compliance...
Learn how FDA is regulating AI in drug manufacturing and quality control. Expert analysis of current guidance, GMP expectations, and compliance steps. Get...
The FDA approved Avlayah (tividenofusp alfa-eknm) for Hunter syndrome neurologic manifestations. Learn what this means for rare disease sponsors and your...
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...
How is FDA regulating AI in drug manufacturing? Learn the current framework, key guidance, and what manufacturers must do now. Expert analysis by Jared Clark.
FDA's new Commissioner's National Priority Voucher Pilot Program could reshape regulatory timelines. Learn what it means for your business and how to comment.
FDA approves 7.2 mg Wegovy under the National Priority Voucher Program. Learn what this means for your business and how to stay compliant. Expert analysis...
Learn what quality systems, line clearance protocols, and packaging controls prevent IV drug mix-up recalls like wrong-drug-in-bag events. Expert FDA...
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...
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...
Complete guide to FDA registration for foreign manufacturers—U.S. agent requirements, facility registration steps, and compliance deadlines. Get expert help...
Lockout Supplements recalled Boner Bears Chocolate Syrup for undeclared sildenafil. Learn what this FDA enforcement action means for your compliance strategy.
Learn what the Go Raw LLC thiamine recall means for pet food compliance. Practical FDA guidance, AAFCO rules, and prevention strategies from Certify Consulting.
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.
CMS issued an RFI on healthcare fraud regulations (CRUSH). Learn what changed, key deadlines, and practical compliance steps from FDA expert Jared Clark.
CMS issued a major RFI on healthcare fraud regulations. Learn what the CRUSH rule means for your organization and how to respond before the deadline.
FDA files Ecoflora Cares petition to add jagua blue as a pet food color additive. Learn what changed, compliance timelines, and next steps.
GO Raw LLC expands voluntary recall of Quest Diet Cat Food for low thiamine. Learn FDA requirements, compliance obligations, and what pet food makers must do...
Learn what quality systems & nutrient testing protocols prevent pet food recalls like the Go Raw LLC thiamine deficiency case. Expert FDA compliance guidance.
USA LESS Co. is recalling Rhino Choco VIP 10X for undeclared tadalafil. Learn what this means for retailers, consumers, and FDA compliance. Act now.
Savannah Bee Company recalls Honey BBQ Sauce-Mustard for undeclared wheat and soy. Learn FDA allergen labeling rules and compliance steps.
Learn what quality systems, allergen controls, and labeling protocols prevent undeclared wheat and soy recalls. Expert FDA compliance guidance from Certify...
Learn how robust allergen controls, labeling SOPs, and FSMA compliance prevent undeclared wheat and soy violations. Expert guidance from Certify Consulting.
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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.