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Drug company executives recommend ways FDA could increase the use of real-world evidence in regulatory decisions.[ Price : $8.95]
FDA warns South Koreas Huons Co. about CGMP violations in its manufacturing of finished drugs.[ Price : $8.95]
A Skadden Insights post raises the concern of FDA-regulated companies caused by the significant leadership changes at the agency.[ Price : $8.95]
FDA issues an early alert warning healthcare providers about a potentially high-risk device issue involving introducer kits used w...[ Price : $8.95]
FDA warns Amazon it is marketing unapproved new drugs on its Web site.[ Price : $8.95]
Former FDA commissioner Scott Gottlieb supports the agency's newly announced initiative to accelerate early-stage clinical trials...[ Price : $8.95]
FDA posts a draft guidance outlining how sponsors can use quantitative systems pharmacology models to determine starting doses for...