Podcast: REMS and restricted generic access


Date: 2 August 2017. Duration: 5:29.

MLex Chief Global Antitrust Correspondent Leah Nylen talks with Assistant Editor North America Can Celik about Risk Evaluation and Mitigation Strategies [REMS] and steps the US Food and Drug Administration is considering to ensure branded drugmakers can't use restricted distribution plans to prevent generics from entering the market.

For more on this issue, read Leah's recent insight "FDA to consider making REMS letters public as generics makers urge more action to prevent abuse" (18 July 2017)


Leah Nylen

Chief Global Antitrust Correspondent