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Federal Register Notice: FDA seeks comments on requirements on content and format of labeling for human prescription drug and biol...[ Price : $8.95]
Cephalon agrees to pay $425 million to resolve criminal and civil charges over alleged off-label promotions involving Gabitril, Ac...[ Price : $8.95]
An FDA analysis provides new evidence that statins do not increase the incidence of amyotrophic lateral sclerosis.[ Price : $8.95]
An FDA Early Communication says the agency is analyzing data from a German clinical trial showing there were more deaths in patien...[ Price : $8.95]
Indevus Pharmaceuticals and FDA reach an agreement on additional safety data and a risk management strategy that will be submitted...[ Price : $8.95]
GPhA says Congress should act to specifically exclude bioequivalence studies from FDA Amendments Act requirements for clinical tri...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance on end-of-phase 2A meetings for IND sponsors who wish to utilize clinical t...[ Price : $8.95]
Federal Register Notice: FDA publishes its list of approved PMAs.