The FDA warned API manufacturer Yuki Gosei Kogyo about major data integrity violations observed during a Nov. 13-17 inspection of its facility in Fukushima, Japan. Source: Drug Industry Daily
The World Health Organization (WHO) invited comments on a draft question-and-answer document that aims to clarify its 2009 guidelines on the evaluation of biosimilars. Source: Drug Industry Daily
The FDA Tuesday released its fiscal year 2019 fee rates for drug compounders that register with the agency as outsourcing facilities. Source: Drug Industry Daily
Pfizer CEO Ian Read said he expects the White House to do away with drug rebates as part of its push to reduce drug prices. Source: Drug Industry Daily
The FDA issued a Form 483 to active pharmaceutical ingredient manufacturer IDT Australia citing quality shortcomings and other deviations observed during a December inspection of its Boronia, Victoria, facility. Source:…
The European Medicines Agency (EMA) on Monday issued updated guidelines for the agency’s orphan designation submission process. Source: Drug Industry Daily
The FDA released its BsUFA II fees for FY 2019, lowering biological product development fees from the fiscal 2018 rates while leaving application and program fees unchanged. Source: Drug Industry…
The House Energy & Commerce Committee has called on the Federal Trade Commission to “closely analyze” recent mergers by pharmacy benefit managers to assess the impact on prescription drug prices.…
The FDA sent a warning letter to compounder Gipsco Investment cautioning that it’s not exempt from the agency’s oversight and was producing adulterated and misbranded products. The action stems from…
The FDA released an updated version of its 2013 Manual of Policies and Procedures (MAPP) outlining CDER’s procedures for determining pharmacologic classes for use in prescribing information for drugs. Source:…