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. Source:…

The European Medicines Agency updated its guidance on post-authorization procedures, including recommendations for sponsors to voluntarily seek scientific advice. Source: Drug Industry Daily

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…

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…

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…