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Federal Register Notice: FDA releases a guidance on implementing medical device establishment registration and device listing requ...[ Price : $8.95]
The National Institute for Occupational Safety and Health says it is using FDA approval information to revise its list of drugs co...[ Price : $8.95]
FDAs Antiviral Drugs Advisory Committee recommends that FDA approve a broader indication for Pfizers HIV drug Selzentry.[ Price : $8.95]
FDA approves an APP Pharmaceuticals ANDA for a generic copy of GlaxoSmithKlines migraine drug Imitrex injection in two dosage stre...[ Price : $8.95]
We post to our Web site latest FDA-483s, EIRs received from FDA pursuant to our FOIA requests, for Mark Adams, MD; Custom Ultrason...[ Price : $8.95]
CDERs Lawrence Lesko says the way in which Amgen and BMS/Imclone approached retrospective analysis of trial data for relabeling th...