Drug Review Documents Hint At Impact Of Broad Changes At FDA
The last year has been a year of dramatic changes at FDA, as the agency implements the sweeping new authorities of the FDA Amendments Act. As industry tries to stay abreast of the new world of FDA, taking a closer look at how some of those changes played out in individual case studies - through the lens of Pharmaceutical Approvals Monthly's drug review profiles - can yield valuable lessons for companies preparing for the gauntlet of an FDA review
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Every month, Pharmaceutical Approvals Monthly dissects a new drug review by FDA. Using FDA’s own review documents, including the discipline reviews, decision memos, meeting minutes, emails, and other documents, we strive to illuminate the agency decision-making process.
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