The US Food and Drug Administration (FDA) is proposing several changes to its adverse event reporting forms, known within the industry as Forms 3500, 3500A and 3500B. FDA has three adverse event ...
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is bringing sweeping changes to the cosmetics industry. One such change requires a “responsible person” to maintain and submit certain ...
Adverse reactions to prescription drugs (adverse drug events, or ADEs) are quite common and usually do little harm to patients. But in a small percentage of cases, they can have serious consequences ...
Consolidating adverse event databases is a smart move, but without public education, real-time transparency risks becoming ...