Archive for August 2018

The U.S. District Court for the District of New Jersey issued a permanent injunction barring online distributor Just Enhance from illegally selling sexual enhancement products on more than 100 websites. Source: Drug Industry Daily

A European Union task force released a two-year plan on Wednesday to prevent or deal with drug shortages in the region. Source: Drug Industry Daily

In the latest CMS move aimed at reducing drug prices, Administrator Seema Verma released new guidance on how Part D plan sponsors can negotiate formulary coverage based on specific indications starting in 2020. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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 Industry Daily

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 opioid alternatives and improve benefit and risk assessments of new opioid drugs in the works. Source: Drug Industry Daily

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 Daily

In a citizen petition filed Monday, Pfizer asked the FDA to issue draft guidance to prevent misleading communications by reference drug sponsors on the effectiveness of biosimilars.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 Daily

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