We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA is undertaking changes to its premarket and postapproval risk-assessment programs in an effort to minimize the injuries patients suffer from prescription drugs, according to federal officials.
The FDA yesterday issued a series of guidances designed to help drug manufacturers comply with its new final rule on labeling of human prescription drugs and biologic products.
The FDA yesterday issued sweeping changes to its drug labeling rules and published four guidance documents designed to help drug manufacturers comply with the first major revision to labeling in more than 25 years.
The FDA listened carefully to industry, answered many important questions and clarified other issues in its new structured product labeling (SPL) Implementation Guide for FDA Content of Labeling Submissions and companion guides, experts tell PIR.
State lawmakers are considering a legal challenge to a proposed FDA rule, which they argue improperly limits state authority to require more stringent labeling requirements.
Clinical trial sponsors should establish data monitoring committees (DMCs) to enhance the safety of trial participants when safety concerns are unusually high, according to a recent FDA draft guidance that helps sponsors determine when DMCs are needed and how such committees should operate.
The FDA’s latest bid to accelerate new drug approvals, while praised by the pharmaceutical industry, is facing a backlash from some lawmakers and advocacy groups who point to the proposal as evidence the agency is too close to industry and does not place enough emphasis on public health.
The National Academies’ Institute of Medicine (IOM) will hold its final drug safety meeting this week in preparation for a long-awaited report that observers say could serve as a catalyst for drug safety legislation.
The FDA has released a series of guidances and a final rule aimed at speeding products to market by streamlining the investigational new drug (IND) application process.