Regulatory Affairs Professionals Society

FDA to exempt five more unclassified devices from premarket notification

The US Food and Drug Administration (FDA) announced its intent on Thursday to exempt certain unclassified medical devices ...
RAPS

FDA issues long-awaited final NDC rule

The US Food and Drug Administration’s (FDA) widely anticipated final rule on national drug codes (NDCs) was published on Wednesday. The rule, which will take effect on 7 March 2033, replaces the ...

Food and Drug Administration (FDA): What It Is and Does

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.
Health Affairs

The FDA Amendments Act And Drug Safety: Where Are We Twenty Years Later?

Nearly two decades ago, Congress passed the US Food and Drug Administration (FDA) Amendments Act of 2007 , partially in ...