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FDA Issues New Draft Guidance on Identification of Suspect Products and Notification

Meredith Manning

Meredith Manning,

Washington, D.C.

Michael N. Druckman

Michael N. Druckman,

Washington, D.C.

Sari Bourne

Sari Bourne,

Washington, D.C.

16 June 2014
On June 11, 2014, the FDA announced the availability of a draft guidance entitled "Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification." The draft guidance clarifies for trading partners certain new requirements in the Federal Food, Drug, and Cosmetic Act, as amended by the Drug Supply Chain Security Act (DSCSA). The DSCSA mandates that certain trading partners investigate "suspect products" and notify the FDA and immediate trading partners regarding "illegitimate products," both of which are defined in the DSCSA. The draft guidance identifies scenarios that could increase the risk of a "suspect product" entering the drug supply chain, recommends certain precautions that should be taken by supply chain trading partners to identify "suspect products," and sets forth the process by which trading partners should act in notifying the FDA of "illegitimate products" and terminating this notification. Although the draft guidance is informative, it does not address certain ambiguities that may be important to assess the obligations that it discusses. For more information on the draft guidance, please click here.
Meredith Manning

Meredith Manning,

Washington, D.C.

Michael N. Druckman

Michael N. Druckman,

Washington, D.C.

Sari Bourne

Sari Bourne,

Washington, D.C.

EMA to Revise Herbal Medicines Guideline

On 1 September 2016, the European Medicines Agency ("EMA") opened for public consultation a Draft revision to its Guideline on the assessment of clinical safety and efficacy in the...

08 September 2016
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