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REMS Abuse Website: Has It Changed The Behavior Of Innovators?

Executive Summary

Updated numbers from the US FDA's REMS abuse website show that Celgene has received two additional safety determination letters, raising question's about whether the public list has changed the practices of brand companies hindering generic company access to samples.

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Gottlieb: Brand Industry 'Gaming' Tactics Have Shifted

US FDA's focus on areas such as REMS abuse may have prompted certain brand sponsors to shift their focus to the commercial space to keep generic competition off the market, former commissioner Scott Gottlieb tells the Association for Accessible Medicines.

Gottlieb: Branded Industry 'Gaming' Tactics Have Shifted From Regulatory To Commercial Space

US FDA's focus on areas such as REMS abuse may have prompted certain brand sponsors to shift their focus to the commercial space to keep generic competition off the market, former commissioner Scott Gottlieb tells the Association for Accessible Medicines.

Gottlieb Tells Brand Firms To Sell Samples For Generics – Or Face The Consequences

The idea could help quiet growing criticism over system gaming and high drug prices.

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