In her third report on opioid abuse in the U.S., Sen. Claire McCaskill (D-Mo.) recommends giving the DEA more authority to penalize pharmaceutical distributors for failing to meet reporting obligations,…
A new report from four Democratic senators claims contacts between Novartis and President Donald Trump’s former personal attorney and Novartis were more extensive than previously disclosed. Source: Drug Industry Daily
Sponsors of drugs to treat hypertension have two approval options, explains an FDA draft guidance released Friday. Source: Drug Industry Daily
The FDA issued an alert Friday about a possible extortion scam targeting consumers, stating that imposters are issuing forged FDA warning letters to individuals who attempt to purchase medications online…
The Healthcare Distribution Alliance has sued the state of New York over a new law that imposes a $600 million surcharge on opioid manufacturers and distributors. Source: Drug Industry Daily
Citing favorable clinical trial data, an FDA advisory committee voted Thursday in favor of the safety and efficacy of GlaxoSmithKline’s new drug application for tafenoquine indicated for radical cure and…
FDA Commissioner Scott Gottlieb said the agency will form a new drug shortage task force to seek solutions to the ongoing drug shortages. Source: Drug Industry Daily
In a follow-up inspection to a March 2017 warning letter, the FDA issued a Form 483 to Ranier’s Compounding Laboratory, accompanied by a public safety alert warning healthcare professionals and…
Cosmo Technologies filed a second lawsuit against Actavis alleging the drugmaker infringed upon Cosmo’s patent with its newly approved generic for the colitis drug Uceris (budesonide). Source: Drug Industry Daily
The FDA issued an untitled letter to Arog Pharmaceuticals for promotional claims it made on a display booth and a webpage about an unapproved investigational new drug’s safety and efficacy.…