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Despite being closed for more than a year, OTC drugmaker American Family Pharmacy was hit with an FDA warning letter for a litany of cGMP violations, including failing to follow quality control procedures, lacking production and process control procedures and having misbranded drug products. Read More
The HHS Office of Inspector General is planning to examine the FDA’s oversight of postmarketing studies of approved drugs and how well information exchange is occurring in the pharmaceutical supply chain as part of its six priorities for the agency in fiscal year 2016. Read More
Taking aim at what they call the “skyrocketing costs of pharmaceuticals,” Democratic members of the House Committee on Oversight & Government Reform are slated to launch the Affordable Drug Pricing Task Force during a press conference today. Read More
Valeant is offering patients access to its dermatology products for zero dollar copay under a program through major pharmacy chains and independent pharmacies. Read More
The pharmaceutical and biologics industries aren’t hiding their displeasure with a decision from the Centers for Medicare & Medicaid Services to treat all biosimilars based on the originator product as identical for billing and reimbursement purposes. Read More
The FDA issued eight warning letters to active pharmaceutical ingredient manufacturers during fiscal year 2015 — all of them to non-U.S. companies and all for data integrity issues. Read More
A Texas drug compounder is recalling all lots of its sterile drug products after an FDA inspection found it had not investigated failed sterility tests. Read More
The European Commission released new rules clarifying the responsibilities of qualified persons overseeing global, multisite manufacturing operations and the data they need to collect. Read More