🎓 Regovant Knowledge Hub

The Complete
FDA Regulatory
Knowledge Hub

17 expert modules covering every FDA-regulated product category — from facility registration to enforcement actions. Written for regulatory consultants, international exporters, and compliance professionals who need to get it right.

17
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Foundations — Understanding the System 4 modules
Registration Tracks — By Product Category 7 modules
Module 05
🥦
Food & Beverages
FSMA, facility registration, Prior Notice, GRAS, allergens
FSMAPrior NoticeFSVP21 CFR 117
Complete food facility registration workflow, biennial renewal, Prior Notice timing, FSMA preventive controls, GRAS, allergen declarations (including the new sesame requirement), and the Nutrition Facts 2020 update.
⏱ 18 minRead →
Module 06
💊
Human Drugs
NDA, ANDA, OTC monographs, drug establishment registration
NDAANDA21 CFR 210-211NDC
The four drug approval pathways, annual establishment registration, fee structure, NDC numbers, the Orange Book, expedited programs (Breakthrough, Fast Track, Priority Review), and cGMP fundamentals.
⏱ 20 minRead →
Module 07
🐾
Veterinary Drugs
NADA, ANADA, CVM, VFD, withdrawal periods, Arthrin® case study
NADACVMVFDMUMS
CVM's dual mandate, the four veterinary drug approval pathways, animal food vs. drug classification, OTC/Rx/VFD distinctions, withdrawal periods, complete label requirements, and the Arthrin® buffered aspirin case study.
⏱ 14 minRead →
Module 08
🩺
Medical Devices
510(k), PMA, De Novo, UDI, device classification, QSR
510(k)PMAUDI21 CFR 820
Device classification system (Class I/II/III), the three clearance/approval pathways, QSR/Design Controls, UDI/GUDID requirements, post-market surveillance, and the device vs. accessory distinction.
⏱ 17 minRead →
Module 09
✨
Cosmetics & MoCRA
MoCRA registration, safety substantiation, labeling, claims
MoCRASafetyFragranceINCI
The MoCRA revolution in cosmetics regulation — facility registration, product listing, safety substantiation, prohibited ingredients, and the cosmetic vs. drug line with real-world claim examples.
⏱ 15 minRead →
Module 10
💊
Dietary Supplements
DSHEA framework, structure/function claims, NDI, cGMP
DSHEANDI21 CFR 111Claims
DSHEA's regulatory framework, the three claim types (structure/function, health claim, nutrient content), NDI notification, cGMP for supplements, and the supplement vs. drug boundary.
⏱ 16 minRead →
Module 11
🧬
Biologics & Vaccines
BLA, biosimilars, CBER products, combination products
BLABiosimilarsCBER351(k)
CBER's product scope, BLA vs. NDA, the biosimilar pathway under 351(k), interchangeability, blood and tissue regulations, combination product designation, and the BPCIA "patent dance."
⏱ 14 minRead →
Operations — Compliance in Practice 5 modules
Module 12
🏷️
Labeling Deep Dive
FDA labeling requirements by product — food, drug, device, cosmetic
Drug FactsNutrition FactsMisbranding
Side-by-side labeling requirements for all six product categories, principal display panel rules, required vs. optional claims, common misbranding violations, and the label review checklist consultants use.
⏱ 17 minRead →
Module 13
🚢
FDA Import Process A–Z
PREDICT scoring, import alerts, refusal grounds, Prior Notice
PREDICTDWPEPrior NoticeImport Alert
The complete 10-stage import flow, PREDICT risk scoring, six key import alerts with removal strategies, all nine grounds for refusal, Prior Notice operational checklist, and the pre-shipment compliance checklist.
⏱ 15 minRead →
Module 14
⚙️
GMP & Quality Systems
ALCOA+, key documents, validation, quality metrics, gap assessment
ALCOA+CAPAValidationData Integrity
GMP regulations across all six product categories, the ALCOA+ data integrity standard, eight essential quality documents, validation types, quality metrics FDA monitors, and a GMP gap assessment framework.
⏱ 13 minRead →
Module 15
🔍
FDA Inspections
Inspection types, Form 483, EIR outcomes, responding effectively
Form 483NAI/VAI/OAIPAIEIR
Six types of FDA inspections, what investigators do at each stage, Form 483 process, the three EIR classification outcomes, how to write an effective 483 response, and the top 10 things investigators look for first.
⏱ 12 minRead →
Module 16
⚖️
Enforcement & Warning Letters
Escalation ladder, Warning Letters, recalls, seizures, debarment
Warning LetterRecall ClassesConsent Decree
The complete enforcement escalation ladder from Warning Letter to criminal prosecution, Warning Letter anatomy and response strategy, recall Class I/II/III obligations, the Warning Letter database as a consultant research tool, and debarment.
⏱ 13 minRead →
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