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For more information and assistance in filing other FDA forms and compliance with OTC Drug regulations visit Steinberg Consult. 
CLICK HERE

HOLLY YOUNG
For assistance in designing Drug Facts Labels, contact Holly Young's web site.
CLICK HERE

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Report Reaction, LLC

DAVID STEINBERG HONORED FOR REGULATORY EXCELLENCE - Read More

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On December 22, 2006, the President signed into law the Dietary Supplement and Nonprescription Drug Consumer Protection Act.  This law amends the Federal Food Drug and Cosmetic Act with respect to serious event reporting and recordkeeping for dietary supplements and non-prescription drugs marketed without an approved application. 

Report Reaction was established to aid both US and Foreign manufacturers who sell OTC Drugs, subject to a Drug Monograph, in the US, to comply with these new labeling requirements for their Drugs.

More information may be obtained in the above folders labeled US OTC Drug Marketers or Foreign Drug Marketers.

For assistance in filing other FDA forms and compliance with OTC Drug regulations, please contact David C. Steinberg at www.Steinbergconsult.com

For assistance in designing Drug Facts labels, contact Holly Young at  www.hirschhornandyoung.com

David C. Steinberg
President