FDA Commissioner Scott Gottlieb announced more recalls Thursday in the FDA’s ongoing investigation into contaminated valsartan products and said the impurity may be a byproduct of the API manufacturing process.…
The FDA called out Indian API manufacturer Vamsi Labs for failing to complete investigations at its Solapur, Maharashtra facility, including one of API batches shipped to the U.S. Source: Drug…
FDA Commissioner Scott Gottlieb Wednesday said the agency plans to scrap its existing guidance on developing new pain drugs and replace it with guidances designed to promote development of new…
The FDA on Tuesday issued Ascend Therapeutics an untitled letter over misleading claims for its estrogen therapy Estrogel. Source: Drug Industry Daily
Drug sponsors wishing to take part in the FDA’s pilot meeting program to discuss complex innovative trial designs (CIDs) with agency staff may now file meeting requests. Source: Drug Industry…
In a citizen petition filed Monday, Pfizer asked the FDA to issue draft guidance to prevent misleading communications by reference drug sponsors on the effectiveness of biosimilars. Source: Drug Industry…
Compounding pharmacy Kelley-Ross & Associates in Seattle drew a warning letter from the FDA after an agency inspection in July found numerous sanitation violations. Source: Drug Industry Daily
A New York couple filed a class-action lawsuit against a distributor and two dispensers of valsartan products, claiming they were exposed to carcinogenic materials. Source: Drug Industry Daily
A federal court in Delaware Monday refused to undo a 2017 decision awarding $70 million to Amgen in its patent infringement battle with Hospira. Source: Drug Industry Daily
Illinois consumers covered under the Affordable Care Act will have access to expanded coverage for opioid addiction in 2020. The move comes after the Centers for Medicare and Medicaid Services…