[ Price : $8.95]
FDA publishes a guidance clarifying how it evaluates real-world data to determine if they are sufficient to provide real-world evi...[ Price : $8.95]
FDA selects investigational cholesterol and cancer drugs from Merck for expedited regulatory reviews under its Commissioner's Nati...[ Price : $8.95]
FDA issues a Warning Letter to Catalents Bloomington, IN, drug manufacturing plant, citing significant manufacturing violations af...[ Price : $8.95]
Diamond Research Foundation founder Beth Rosenshein petitions FDA to update Premarin labeling with information on the estrogen hor...[ Price : $8.95]
Two Mintz attorneys urge stakeholders to monitor FDA communications involving compliance and review carefully, looking for issues ...[ Price : $8.95]
FDA approves GSKs Exdensur (depemokimab-ulaa), an ultra-long-acting biologic for severe asthma.[ Price : $8.95]
A Medshadow column raises concerns about FDAs stated efforts to allow some drugs to be approved based on a single pivotal trial.[ Price : $8.95]
FDA warns San Diego, CA-based Microvascular Tissue about CGMP violations in its production and marketing of an unapproved new drug...