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The Prescription Interdiction and Litigation Task Force is looking at existing lawsuits against opioid manufacturers by state and local governments to offer federal assistance where possible. Read More
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee is requesting that sponsors of antiretrovirals submit, by May 8, supplementary safety information related to the risk of autoimmune hepatitis. Read More
Wisconsin and West Virginia passed laws allowing pharmacists to substitute interchangeable biosimilars, bringing the total number of states with such laws to 40. Read More
Three senators wrote to Tri-Source Pharma demanding an explanation for dramatic price spikes for the company’s off-patent cancer drug lomustine. Read More
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Vertice Pharma asked the FDA to revise its draft guidance on bioequivalence requirements for sucralfate oral suspension ANDA to accept in vitro studies for bioequivalence to the reference drug.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