The European Commission issued revised guidance for regulatory authorities, marketing authorization applicants and holders on the listing of excipients on product labeling and package leaflets. Source: Drug Industry Daily
Oregon’s Senate advanced legislation that would introduce a drug cost and price transparency program, sending it to Gov. Kate Brown (D) for signature. Source: Drug Industry Daily
The FDA served Korean drug manufacturer Nowcos a warning letter after an inspection revealed multiple validation deficiencies and inadequate stability studies. Source: Drug Industry Daily
Following FDA inspections and a warning letter, the Department of Justice filed a civil complaint against the outsourcing facility Cantrell Drug Company, of Little Rock, Arkansas seeking a preliminary injunction…
A Valeant Pharmaceuticals unit agreed to pay $58 million to settle multi-district litigation that accused it of violating antitrust laws to keep generic versions of Solodyn off the market. Source:…
Attorney General Jeff Sessions directed the Drug Enforcement Agency to evaluate the possibility of lowering caps on opioid production for drugmakers. Source: Drug Industry Daily
A pediatric cardiologist pleaded guilty to illegally supplying Aegerion Pharmaceuticals with information about his patients. Source: Drug Industry Daily
Sen. Claire McCaskill (D-Mo.) introduced legislation that would eliminate tax breaks for drugmakers that advertise directly to consumers. Source: Drug Industry Daily
The FDA issued two draft guidances aimed at implementing the Drug Supply Chain Security Act’s provisions for an electronic track-and-trace system for certain prescription drugs extending throughout the supply chain…
The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a revised guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease, focusing on the design…