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The FDA has issued a warning letter to Rainbow Gold Products in Sardis City, Ala., a drug repackaging and relabeling facility, for products containing a misbranded and mislabeled drug. Read More
The European Medicines Agency updated its guidance on post-authorization procedures, including recommendations for sponsors to voluntarily seek scientific advice. Read More
Health Canada is proposing changes to its prescription drug pricing regulations with the establishment of a risk-based approach, applying new economic factors in the decision framework, and updating the list of countries it uses for average price comparisons. Read More
Merck and Upsher-Smith Laboratories agreed to pay $60.2 million to settle a 17-year-long class action suit over plans to delay a generic potassium deficiency treatment — a case that survived three rounds of mediation, over four years of discovery, and a trip to the U.S. Supreme Court. Read More
Even though the FDA user fee reauthorization bill is well on its way through Congress, HHS Secretary Tom Price is appealing to lawmakers to push for an increase in fees that would leave industry footing the entire bill for medical product approvals. Read More
In a letter sent Tuesday to President Trump, 11 Senate Democrats urged the White House to scrap plans for fiscal 2018 budget cuts that would affect implementation of the 21st Century Cures Act. Read More