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Reminder: US FDA Drug Listing Renewals 2026

by Srishti Chaudhari | Oct 13, 2026 | FDA

As the annual renewal period approaches, companies marketing drugs in the US should begin reviewing their FDA establishment registrations and drug listings. The annual renewal period runs from October 1 through December 31, 2026. During this period, companies should...

Navigating MoCRA Compliance: FDA Confirms No Official Verification Certificates Are Issued for Cosmetic Registrations

by Sagarika Sharma | Oct 13, 2026 | FDA, MoCRA

Cosmetic brands and manufacturers navigating e-commerce onboarding have recently faced growing pressure to produce official government documentation proving their regulatory standing. In a September 9, 2026 announcement, the U.S. Food and Drug Administration (FDA)...

OTC Sunscreen Monograph Update: FDA Finalizes Removal of PABA and Trolamine Salicylate

by Sagarika Sharma | Oct 13, 2026 | FDA, OTC Sunscreen Monograph Update

The U.S. Food and Drug Administration (FDA) has released a final administrative order officially delisting two active ingredients: aminobenzoic acid (PABA) and trolamine salicylate from the over-the-counter (OTC) sunscreen monograph. Following its regulatory...

FDA Implements Split Payment Framework for FY 2027 OTC Monograph Facility Fees

by Sagarika Sharma | Oct 13, 2026 | FDA

The U.S. Food and Drug Administration (FDA) has established a two-part installment plan for Fiscal Year (FY) 2027 Over-the-Counter (OTC) monograph drug facility user fees. Under this payment schedule, regulated drug establishments must remit their annual facility fees...

FDA issues warning letters to OTC companies over talc testing

by Srishti Chaudhari | Oct 13, 2026 | FDA

In June 2026, the FDA issued nine warning letters to OTC companies over products containing talc, citing concerns about potential asbestos contamination. The letters identified cGMP deficiencies involving ingredient and finished product testing, supplier...

FDA Warning Letter Trends

by Srishti Chaudhari | Oct 13, 2026 | FDA

Recent FDA warning letters to topical OTC manufacturers continue to highlight familiar GMP deficiencies, with supplier oversight and analytical testing emerging as recurring areas of focus. In an August warning letter, the FDA emphasized that companies remain...

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Reminder: US FDA Drug Listing Renewals 2026

Navigating MoCRA Compliance: FDA Confirms No Official Verification Certificates Are Issued for Cosmetic Registrations

OTC Sunscreen Monograph Update: FDA Finalizes Removal of PABA and Trolamine Salicylate

FDA Implements Split Payment Framework for FY 2027 OTC Monograph Facility Fees

FDA issues warning letters to OTC companies over talc testing

FDA Warning Letter Trends

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