FDA revises guidance on postmarketing studies to reflect ARIA system, SUPPORT act
The FDA on Thursday revised its draft guidance on postmarketing studies and clinical trials under Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The FDA says the draft guidance, first issued for comment in 2011, is being revised to detail the factors the agency considers when determining whether a postmarketing study or clinical trial will be required for a drug or biologic or whether postmarketing reports and the agency’s active postmarket risk identification and analysis (ARIA) system are sufficient to assess a product’s risks in the postmarket setting.
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