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The Chinese government adopted a major reshuffling of its cabinet departments late last month, including restructuring the State Food and Drug Administration under the authority of a new umbrella agency, the State Market Regulatory Administration. Read More
The research showed that a substantial proportion of off-patent drugs could have additional manufacturers if a system of reciprocal approval were developed. Read More
Vertice Pharma asked the FDA to revise its draft guidance on bioequivalence requirements for sucralfate oral suspension ANDA to accept in vitro studies for bioequivalence to the reference drug. Read More
The FDA could offset drug price spikes or shortages by allowing reciprocal approvals for certain generic drugs with limited competition, according to joint research from Johns Hopkins, Yale, Harvard and the Council on Foreign Relations, published in BMJ. Read More
The FDA released its justification for the administration’s fiscal year 2019 budget request, detailing how the agency would allocate funds to boost pharmaceutical innovation, combat the opioid crisis and reform over-the-counter drug regulation among other priorities. Read More