A new package insert rule from the federal Food and Drug Administration is designed to better manage the risks of medication use and reduce medication errors, according to the agency. Under the rule, ...

Jan. 18, 2006 — -- For the first time in 25 years, the Food and Drug Administration will change the requirements for the lengthy package inserts that are included with most prescription drugs.

Every doctor knows of the package insert: the little paper with tons of fine print that is enclosed with medication bottles. In short: package inserts are the formal “labeling” mandated by the the ...

For the first time in 25 years, the US Food and Drug Administration has implemented major changes to the way prescription drug leaflets are presented, in a bid to clarify the information they contain ...

(THE CONVERSATION) – Many adults take prescription drugs, and usage rates are continually increasing. With approximately 1.3 million emergency department visits in the U.S. caused by adverse drug ...

Trying to decipher the medical jargon on drug labels can be daunting for the average consumer. Even doctors have trouble. But the stakes are high: Research suggests that medication errors may be ...

WASHINGTON — Embarrassed by reports of deaths linked to painkillers and suicides related to antidepressants in 2004, the Food and Drug Administration went into information overdrive. It issued more ...

Variability in drug response to many therapeutic drug classes is well recognized. These interpatient differences have been seen for both drug efficacy and adverse effects. Pharmacogenomics (Pgx) aims ...

The absence of safety and efficacy data for drugs in individuals with obesity in package inserts may compromise health outcomes. Bruno Halpern, MD, PhD, a specialist in endocrinology and internal ...