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is proceeding with its plans for compulsory patient package inserts (PPIs) in all prescription drugs , but there are no data as to the safety and effectiveness of this major therapeutic innovation. The article ...
Under a new Food and Drug Administration's proposal , consumers could receive an information leaflet, called a patient package insert or PPI, with most prescription drugs . This study examines ...
elected to take the drug once they had pur chased it; only a few seem to have chrmged their decision as Patient package inserts (PPIs) fared well in an FDA -spon a result of the information they received. 5 ...
Abstract Background The Food and Drug Administration ( FDA ) and pharmaceutical manufacturers conduct most postmarketing pharmaceutical safety investigations. These efforts are frequently based on data ...
, often including a boxed warning in bold print. Patient -directed package inserts for drugs with rare but potentially lethal adverse effects also have become increasingly common. Options Explored "We've ...
about limitations in the effectiveness of the package insert , the FDA has surveyed physicians and consulted other health care professionals about optimal labeling. The FDA plans to propose major revisions ...
to container labeling. After reviewing comments to the December 2000 proposed rule “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products,” FDA reconsidered its ...
associated with FDA -approved indications, pharmaceutical manufacturers described 7 in package inserts disseminated between 1 and 14 years following FDA approval of the relevant drug , with a median time of 5 ...
prescription drug labeling via patient package inserts . ACTIVATED CHARCOAL ADSORPTION OF THEOPHYLLINE IN VITRO by Charles Sintek, Leslie Hendeles and Miles Weinberger for most drugs is unknown. Thus the present ...
are generally for injectable drugs or inhalants, include administration information for patients . In 1998, FDA also predicted that most of the medication guides would be required for newly approved drugs ...
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