Monthly Newsletter: Cosmetics, OTC, & Personal Care Products

Monthly Newsletter: Cosmetics, OTC, & Personal Care Products

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Analytical Method Validation: A Recipe for Accurate Results

Validated methods are the gold standard for analytical testing. So, how is a method validated? We explain in simple terms.? ??

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U.S. FDA Posts Catalogue of Historical Monograph Documents

The FDA has updated the OTC Monograph Resources section of its website.

This includes a digital Catalogue of Pre-OMUFA Documents dataset in a?downloadable excel spread sheet. This catalogue includes a list of documents that were only accessible as paper documents prior to the passage of the Coronavirus Aid, Relief, and Economic Security (CARES) Act.

The resource page also includes a link to the?FDA’s Historical Status of OTC Rulemakings webpage?and an?FAQ section.


Cosmetic & Personal Care Claims Substantiation: Advice from an Expert

Our regulatory consulting experts?answer seven questions?about substantiating label claims for your products.

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Drug OTC GMPs and Labeling?

Five-Part Virtual Seminar Series

  • Dates:?May 6, 13, 20, 27, & June 3
  • Time:?1:00 PM (Eastern) for each one-hour session
  • Cost:?$199 (Certified Group customers); $249 (non-customers)

EAS Consulting Group, a?Certified Group?company, is offering this series to help OTC and homeopathic drug manufacturers meet FDA expectations.

Topics covered include pharmaceutical GMPs (21 CFR Part 210 and 211), labeling tied to therapeutic monographs, and facility registration and product listing (21 CFR 207).

Our experts clarify private label distributor obligations, Adverse Events Reporting, and enforcement insights, offering the guidance needed to remain compliant in a rapidly evolving regulatory landscape.

Register Here



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