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  • Regulatory NewsRegulatory News

    Clinton Urges FDA, FTC to Take Action Against Drug Price Hikes

    In two letters sent Monday, Democratic presidential hopeful Hillary Clinton called on the US Federal Trade Commission (FTC) and US Food and Drug Administration (FDA) to take action against pharmaceutical companies that inflate drug prices and keep generics off the market. In her letter to FDA acting commissioner Stephen Ostroff, Clinton echoes a number of similar calls by politicians such as those by Rep. Elijah Cummings (D-MD) , that Turing Pharmaceuticals' 5,000% pric...
  • Regulatory NewsRegulatory News

    How the Clinton, Sanders Plans to Lower the Rise of Drug Prices Will Impact the FDA

    Democratic presidential candidates Hillary Clinton and Sen. Bernie Sanders are attempting to take on an issue the US Food and Drug Administration (FDA) can't control: rising drug prices. But some of their proposals would directly impact FDA authority. On Tuesday, Clinton unveiled a plan that would decrease the market exclusivity for biologics from 12 years to seven years, require drugmakers to spend a minimum amount of money on research and development (R&D), bar ph...
  • New Initiative Aims to Harmonize Africa's Regulations

    A new United Nations-backed initiative aims to give Africans consistent access to "essential, high quality, safe and affordable medicines" through the establishment of regulatory harmonization and capacity-building programs. The initiative, called the East African Community (EAC) Medicines Registration Harmonization Project , brings together several high-level groups, including the New Partnership for Africa's Development (NEPAD), the World Health Organization (WHO)...