FDABridge Blog

Articles for exporters dealing with FDA paperwork

Read practical guides about food registration, MoCRA, drug filings, and the paperwork that comes before your products enter the market.

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DrugNov 4, 2026

Drug Establishment Renewal vs. Blanket No-Changes Certification: What Foreign Drug Manufacturers Must File by December 31

Drug establishment renewal and drug listing certification are two separate year-end filings with the same October 1 to December 31 window. Here is what each covers and what happens to listings that are not certified.

DrugNov 4, 2026

FDA's 12-Digit NDC Final Rule: What Drug Labelers Need to Change Before 2033

FDA has finalized a single 12-digit, 6-4-2 National Drug Code format effective March 7, 2033, followed by a three-year transition. Here is what changes for existing NDCs, new labeler codes, barcodes and listing data.

DrugJul 15, 2026

FDA Drug Establishment Registration for Foreign Manufacturers: New 2026 Proposed Rule Explained

The FDA proposed new drug establishment registration rules in July 2026 that would require more foreign manufacturers to register. Here is what the proposed rule means for foreign API and OTC drug producers.

DrugJun 28, 2026

OTC Drug Registration for Foreign Manufacturers: What the FDA Requires Before You Can Sell in the US

Foreign manufacturers of over-the-counter drugs must register their establishment, obtain an NDC Labeler Code, list each product, and comply with the applicable OTC monograph before selling in the United States.

DrugJun 27, 2026

FDA Drug Listing: How Foreign Manufacturers Submit Product Information Under 21 CFR Part 207

Every drug product sold in the United States must be listed with the FDA using the SPL electronic format — here is how foreign manufacturers navigate the drug listing process.

DrugJun 26, 2026

FDA Current Good Manufacturing Practice for Drugs: What 21 CFR Parts 210 and 211 Require

Foreign drug manufacturers must comply with FDA's CGMP regulations under 21 CFR Parts 210 and 211 — covering facility design, equipment, production controls, testing, and recordkeeping.

DrugJun 25, 2026

Exporting Homeopathic Products to the United States: FDA Registration and Compliance Requirements

Homeopathic drugs are regulated as drugs under the FD&C Act and require FDA establishment registration, NDC listing, and compliance with homeopathic manufacturing and labeling standards.

DrugJun 24, 2026

FDA OTC Monograph Reform: What the CARES Act Changed for Foreign Drug Manufacturers

The CARES Act of 2020 overhauled the OTC drug monograph system, replacing decades-old rulemaking with administrative orders and introducing user fees that affect every foreign OTC manufacturer.

DrugJun 23, 2026

Drug Master Files: What Foreign API Manufacturers Must Know About DMF Submissions to the FDA

Drug Master Files allow foreign API manufacturers to share confidential manufacturing and quality information with the FDA without disclosing it to their customers — here is how DMFs work.

DrugJun 22, 2026

FDA Drug Establishment Inspection: What Foreign Manufacturers Should Expect During a GMP Audit

FDA inspections of foreign drug facilities examine every aspect of CGMP compliance — here is what happens before, during, and after an FDA investigator arrives at your manufacturing site.

DrugJun 21, 2026

Exporting Hand Sanitizers and Antiseptic Products to the US: Why They Are OTC Drugs, Not Cosmetics

Hand sanitizers, antiseptic washes, and antibacterial soaps are regulated as OTC drugs in the United States — not as cosmetics — and require drug establishment registration, NDC listing, and monograph compliance.

DrugJun 20, 2026

Prescription Drug User Fee Act and Foreign Manufacturers: What PDUFA Fees Mean for Market Entry

PDUFA establishes annual establishment fees and application fees that every foreign drug manufacturer must pay to maintain FDA registration and submit drug applications.

DrugJun 19, 2026

FDA Drug Labeling: OTC Drug Facts Panel vs Prescription Drug Labeling Requirements

OTC drugs require a Drug Facts panel under 21 CFR 201.66 while prescription drugs follow the Physician Labeling Rule — foreign manufacturers must apply the correct format for their product classification.

DrugMay 17, 2026

SPF Products in the United States: Why Sunscreens Are Regulated as OTC Drugs, Not Cosmetics

Sunscreens and SPF products are classified as OTC drugs in the US, not cosmetics. Foreign manufacturers who treat them as cosmetics will face import refusals and registration violations.

DrugMay 12, 2026

What Is OMUFA? FY2027 Fees for Foreign OTC Manufacturers

OMUFA fees depend on a facility's actual OTC monograph drug activity. Check the FY2027 fee period, qualifying exclusions and FDA invoice before budgeting.

DrugMay 8, 2026

FDA Drug Establishment Registration: What Foreign Manufacturers Must File

Foreign drug manufacturers must register their establishments with the FDA before distributing drugs in the US. Here is who must register, what is required, and how the annual cycle works.

DrugMay 5, 2026

What Is an NDC Number and How Foreign Drug Manufacturers Obtain One

Understand the marketing company’s labeler code, FDA’s current NDC format, the confirmation SPL, and the separate establishment and product-listing duties.

DrugMay 2, 2026

FDA Drug Labeling Requirements: What Foreign Manufacturers Must Include on US Packaging

FDA drug labeling requirements specify exactly what must appear on US drug packaging — from the Drug Facts panel to allergen declarations. Foreign manufacturers must meet every requirement before the first shipment.