The Cross-Border Biotech Blog

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

Tag Archives: FDA Amendments Act

Dreaming of REMS: A Second Reason Why FDAAA Risk Evaluation and Mitigation Strategies Might Be a Benefit to Drug Developers

Over at The In Vivo Blog, Michael McCaughan has another thought-provoking piece on REMS — the FDA’s Risk Evaluation and Mitigation Strategies that impose tight controls on the distribution channels for certain drugs. Michael compares two drugs for the same indication — opioid-induced constipation therapy, if you must know — and though they have similar [...]

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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