The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: Dr. Reddy’s

REMS and Generics — Like Oil and Water

A great post from Michael McCaughan at the In Vivo Blog walks through the very complicated interaction between the world of REMS — the FDA’s Risk Evaluation and Mitigation Strategies that impose tight controls on the distribution channels for certain drugs — and the world of generics. Under the FDA Amendments Act, which started the [...]

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