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The New Civil Liberties Alliance (NCLA) filed a petition asking the FDA to stop using ‘improper” agency guidance to impose obligations on drugmakers and instead issue clear rules and notice-and-comment procedures. Read More
Multi-district litigation over Roche’s anti-acne drug Accutane (Isotretinoin) hit a wall this week when the New Jersey Supreme Court ruled against allowing certain expert testimony. Read More
The European Medicines Agency said Wednesday it needs to scale back or suspend more activities, blaming Brexit for staff reductions that are disrupting its ability to function. Read More
FDA Commissioner Scott Gottlieb outlined what the agency hopes to learn from an advisory committee Friday at a meeting about safety measures for transmucosal immediate-release fentanyl (TIRF) products. Read More
Medicare could save billions of dollars each year if the federal government negotiated directly with drug companies for all federal drug benefit programs including Medicare Part D, according to a new report released Wednesday by Sen. Claire McCaskill (D-Mo.). Read More
Demopoulos spent a large part of his life researching glutathione and he is credited by Molecular Defenses Corporation as inventing the free radical pathology field. Read More
Biosimilar products have been licensed in some countries as generics or as small molecule drugs with supporting data that don’t meet the WHO’s regulations. Read More