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ARTICLE · 31 MARCH 2017

FDA Issues Its First Postmarketing Safety Reporting Regulations For Combination Products

Finnegan, Henderson, Farabow, Garrett & Dunner LLP
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The Food and Drug Administration (FDA) recently published a final rule setting forth the first postmarketing safety reporting regulations for combination products that have received FDA...

United StatesConsumer Protection
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Jennifer Roscetti
Jennifer Roscetti
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The Food and Drug Administration (FDA) recently published a final rule setting forth the first postmarketing safety reporting regulations for combination products that have received FDA marketing authorization. Postmarketing Safety Reporting for Combination Products, 81(244) Fed. Reg. 92603-92626 (Dec. 20, 2016) (to be codified at 21 C.F.R. pt. 4) ("Final Rule"); see also 21 C.F.R. § 3.2(e) (defining "combination product" as, inter alia, a product comprised of two or more regulated components). The rule has an effective date of January 19, 2017, with some provisions requiring compliance on that date and others requiring compliance within eighteen months. Final Rule at 92603, 92619.

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