In an International Bar Association article, life sciences regulatory & compliance partner Josh Oyster, counsel Beth Weinman and associate Jessica Bushman examined how the US Food and Drug Administration (FDA) has announced sweeping reforms to its drug review and approval processes using an unconventional approach in restricted-access journals to communicate policy changes.
The authors note that industry and consumers of regulated pharmaceutical products may not stand idly by if FDA continues to disregard good guidance practices.
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