The FDA shot Signature Formulations a warning letter arising from an October inspection of the manufacturer’s Phoenix, AZ, facility that revealed cleaning and maintenance deficiencies and failure to test products…
Two Democratic senators slammed HHS Secretary Alex Azar for blaming pharmacy benefit managers and drug distributors — and letting manufacturers off the hook — for high drug prices. Source: Drug…
Drug manufacturers set higher prices even when rebates for pharmacy benefit managers decrease, contradicting allegations that rebates may help drive the increases, according to a new report released by the…
PhRMA slammed a new report from the National Governors Association laying out strategies governors are considering to lower drug prices — including the use of value-based pricing, a cap on…
The Justice Department and the Drug Enforcement Administration are proposing a major cut in production of the most commonly abused opioids in 2019. Source: Drug Industry Daily
Endo lifted its stay of litigation against the FDA and is going ahead with a lawsuit challenging the agency’s policy on bulk drug compounding. Source: Drug Industry Daily
Westminster Pharmaceuticals recalled two of its thyroid drugs after manufacturing them with APIs sourced from a Chinese supplier the FDA cited for GMP violations. Source: Drug Industry Daily
The FDA issued a warning letter to an API manufacturing facility in Yicheng City, Hubei, based on a September 2017 inspection that found many repeat violations including a lack of…
Merck and GlaxoSmithKline called for more information from the FDA in comments on the agency’s draft guidance for sponsors using the limited population pathway for antibacterial and antifungal drugs (LPAD).…
Purdue Pharma violated a 2015 agreement with New York by deceptively marketing opioids, including Oxycontin, New York Attorney General Barbara Underwood alleges in a new lawsuit. Source: Drug Industry Daily