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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Drug

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

Drug

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

Jul 15, 2026

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.

Drug

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

Drug

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

Jun 28, 2026

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.

Drug

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

Drug

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

Jun 27, 2026

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.

Drug

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

Drug

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

Jun 26, 2026

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.

Drug

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

Drug

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

Jun 25, 2026

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.

Drug

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

Drug

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

Jun 24, 2026

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.

Drug

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

Drug

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

Jun 23, 2026

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.

Drug

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

Drug

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

Jun 22, 2026

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.

Drug

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

Drug

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

Jun 21, 2026

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.

Drug

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

Drug

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

Jun 20, 2026

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

Drug

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

Drug

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

Jun 19, 2026

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.

Drug

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

Drug

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

May 17, 2026

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.

Drug

What Is OMUFA and What It Means for Foreign OTC Drug Manufacturers

Drug

What Is OMUFA and What It Means for Foreign OTC Drug Manufacturers

May 12, 2026

OMUFA created mandatory user fees for OTC monograph drug manufacturers. Foreign facilities that make OTC drugs for the US market pay these fees as part of their FDA obligations.

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FDA Drug Establishment Registration: What Foreign Manufacturers Must File

Drug

FDA Drug Establishment Registration: What Foreign Manufacturers Must File

May 8, 2026

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.

Drug

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

Drug

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

May 5, 2026

The NDC number is a required identifier for every drug product sold in the US. Foreign manufacturers must obtain one through the FDA drug listing process before their products can be shipped.

Drug

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

Drug

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

May 2, 2026

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.

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What drug manufacturers should know before FDA listing

Drug

What drug manufacturers should know before FDA listing

Mar 5, 2026

The key setup items to prepare before you begin establishment registration and drug listing work.