FDA Cites Yusef Labs for Inadequate Investigations, Quality Concerns
The FDA put drugmaker Yusef Manufacturing Laboratories on notice over failures to address batch discrepancies and other quality issues. Source: Drug Industry Daily
Tennessee House Speaker Calls on State’s AG to Sue Opioid Makers
The Speaker of the Tennessee House wants the state’s attorney general to be the third in the nation to sue opioid manufacturers. Source: Drug Industry Daily
Mylan, Sandoz, Teva and 10 Other Generics Makers Named in Six Price-Fixing Lawsuits
A pharmacy chain brought class action suits against 13 generics manufacturers — including Mylan, Sandoz, and Teva — claiming they conspired to raise prices of six drugs, including blood pressure…
WHO Updates its Essential Medicines List, Adding Drugs for Hep C, HIV & New Antibiotics
The World Health Organization published its biennial update to its list of essential medicines, adding therapies for hepatitis C, HIV and leukemia, as well as new advice on combating antimicrobial…
483 Roundup: Repeating Problems Result in 483s
The FDA hit multiple manufacturers with extensive Form 483s, including an Ohio outsourcing facility where failures to adhere to GMP and overall sterility, cleaning and quality control issues proved to…
EMA, Experts Take on Brexit Questions
The European Medicines Agency answered the most pressing questions related to the United Kingdom’s exit from the European Union, making it clear UK-made products would be subject to import quality…
Warning Letter Roundup: Variety of GMP Repeat Violations Garner FDA Warnings
Significant GMP violations and repeating problems at U.S. companies across the drug supply chain lead the FDA to issue warning letters, including a lack of product testing at an Oklahoma…
Get Audit-Ready with Internal Checklists, GMP Expert Says
What’s the best way to get ready for an FDA GMP inspection? Practice, says international quality expert Thomas Peither. Self-inspection or a fresh set of eyes in the form of…
As Gottlieb Takes the Helm at FDA, Expect Focus on Workforce
FDA Commissioner Scott Gottlieb spent the early weeks of his tenure in the agency’s top job laying out his priorities before senior FDA staff and members of Congress and announcing…
FY 2018 Budget Request A “Recalibration”
President Trump’s budget for fiscal 2018 proposes a “recalibration” of how the FDA funds its core mission of ensuring the safety and quality of drugs, which would cut federal spending…