FDA Commissioner Scott Gottlieb outlined what the agency hopes to learn from an advisory committee Friday at a meeting about safety measures for transmucosal immediate-release fentanyl (TIRF) products. Source: Drug…
Medicare could save billions of dollars each year if the federal government negotiated directly with drug companies for all federal drug benefit programs including Medicare Part D, according to a…
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.…