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Archive for month: November, 2016

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FTC Plans Crackdown on Marketing Claims of OTC Homeopathic Drugs

The Federal Trade Commission (FTC) on Tuesday announced a new enforcement policy that will hold efficacy and safety claims for OTC homeopathic drugs to the same standard as other products making similar claims.

Regulatory Affairs Professionals Society

Read more at http://www.raps.org/Regulatory-Focus/News

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European Medicines Agency post-authorisation procedural advice for users of the centralised procedure

The EMA has released a guidance document on the post-authorisation centralised procedure.

This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency’s position on issues, which are typically addressed in discussions or meetings with MAHs in the post-authorisation phase.

European Medicines Agency

Source: http://www.ema.europa.eu/docs

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New guidance on type II variations and marketing authorisation extensions for orphan-designated medicines

The European Medicines Agency (EMA) has updated its post-authorisation guidance on extensions of marketing authorisations and type II variations to include further details on the information companies need to provide when submitting a type II variation or a marketing authorisation extension for an orphan-designated medicine.

European Medicines Agency

Source: http://www.ema.europa.eu/ema

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