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The FDA’s Office of Prescription Drug Promotion (OPDP) sent its first warning letter of the year to Outlook Pharmaceuticals of Cincinnati, Ohio over a sponsored link for its ADHD treatment ProCentra (dextroamphetamine sulfate). Read More
Drugmakers spend an average of $1.3 billion in research and development costs to get a new medicine to market, according to a new study reported in JAMA this week, a number considerably lower than a 2016 Tufts report citing development costs of $2.8 billion. Read More
Prescription drug prices increased by more than three times the rate of inflation between 2008 and 2017, according to a new analysis that accounts for rebates and discounts. Read More
The FDA released final guidance yesterday on the transition of insulin and other biological products from new drug applications (NDAs) to biologics license applications (BLAs) as the March 23 transition date looms. Read More
The FDA issued a warning letter to over-the-counter drugmaker Essnd Global for serious GMP deficiencies at its facility in Maharashtra, India. Read More
Connecticut-based online pharmacy Valisure has petitioned the FDA to recall specific batches of the type 2 diabetes drug metformin from numerous manufacturers because it found high levels of N-Nitrosodimethylamine (NDMA) in the products. Read More