HHS has once again pushed back the effective date of its final rule instituting fines for drugmakers that overcharge for products under the 340B drug discount program. Source: Drug Industry…

A bill to reauthorize FDA user fees for the next five years received voice-vote approval from a House health subcommittee Thursday. The measure now heads to the full Energy and…

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…

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…

The FDA published 21 new and 16 revised product-specific draft guidances, outlining methods for establishing bioequivalence for generics. Source: Drug Industry Daily

The FDA has issued a boxed warning for Johnson & Johnson’s Invokana (canagliflozin) treatment for type 2 diabetes, describing a doubled risk of leg and foot amputations compared to placebo.…