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EMA has issued revised guidance for its PRIority MEdicines (PRIME) scheme that provides early consultation and scientific advice between applicants and regulators for medicines under development and not currently authorized in the EU. Read More
Optimizing dietary management during drug trials is critical to accurately assessing drug efficacy in clinical trials for inborn errors of metabolism (IEM), the FDA says in a new draft guidance. Read More
CMS has issued a proposed rule that aims to spend $9 billion to reimburse nearly 1,650 hospitals participating in the 340B drug discount program for underpayment of fees over the past five years. Read More
Coloplast has signed a $1.3 billion agreement to acquire Kerecis, a biologics wound care manufacturer based in Iceland, with an FDA-cleared patented technology platform based on intact fish skin. Read More
The FDA has classified Draeger Medical’s Oxylog 3000 Plus emergency and transport ventilator as class I, the most serious type of recall because of the risk of serious injury or death. Read More
Multiple U.S. government agencies, in collaboration with India’s Directorate of Revenue intelligence, have stopped over 500 shipments of “illicit, and potentially dangerous, unapproved prescription drugs, combination medical devices, and synthetic drug precursors from reaching American consumers.” Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Read More
Novo Nordisk has sought legal action against 10 medical spas, weight loss and wellness clinics, and compounding pharmacies in four states for illegally selling non-FDA-approved compounded and counterfeit semaglutide products. Read More
The European Medicines Agency (EMA), the European Commission (EC) and the Heads of Medicines Agencies (HMA) are phasing out the “extraordinary regulatory flexibilities” that were put in place during the COVID-19 pandemic to ease potential medicine shortages. Read More
The Association of Accessible Medicines (AAM) has filed a lawsuit against a new Minnesota law that controls pharmaceutical pricing, calling the law unconstitutional and discriminatory. Read More