The National Institutes of Health launched a new initiative to address the opioid crisis, increasing funding for research on opioid misuse, addiction and pain from approximately $600 million in fiscal…
The FDA published a final guidance for industry on what applicants should submit for NDAs and ANDAs for liposome products. Source: Drug Industry Daily
U.S. drugmakers could be impacted by the Trump administration’s proposed tariff on thousands of Chinese goods, which includes pharmaceutical products and ingredients used in drug manufacturing — including epinephrine, psychotherapeutic…
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. Source: Drug…
The European Medicines Agency is seeking public comments on a new template for GMP non-compliance statements, specifically in cases where a manufacturing site’s failed inspection could lead to shortages of…
Wisconsin and West Virginia passed laws allowing pharmacists to substitute interchangeable biosimilars, bringing the total number of states with such laws to 40. Source: Drug Industry Daily
Three senators wrote to Tri-Source Pharma demanding an explanation for dramatic price spikes for the company’s off-patent cancer drug lomustine. Source: Drug Industry Daily
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,…
Vertice Pharma asked the FDA to revise its draft guidance on bioequivalence requirements for sucralfate oral suspension ANDA to accept in vitro studies for bioequivalence to the reference drug. Source:…
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…