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With the FDA’s foreign inspections on hold through April due to the coronavirus outbreak, the agency is doing “anything and everything” to make use of international regulators to keep inspections going, according to a senior CDER official. Read More
FDA Commissioner Stephen Hahn announced late yesterday that the agency has suspended routine domestic facility inspections in response to the COVID-19 outbreak. Read More
President Trump announced Wednesday that he is invoking the Defense Production Act in response to the growing coronavirus pandemic, enabling the federal government to order private industry to manufacture emergency medical supplies. Read More
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) found that certain cancer medicines that contain ifosfamide, an injectable chemotherapy drug, pose higher risks of brain damage in solution form than in powder form. Read More
An Indian drug manufacturer’s facility in Salcete, Goa drew a warning letter from the FDA for serious violations, including inadequate cleaning that left drug product residues inside manufacturing equipment. Read More
Drug industry trade groups PhRMA and BIO expressed a strong distaste for the Trump administration’s strategy for tackling high drug prices by importing Canadian medicines, arguing that the plan would fail to lower costs and could put patients at risk. Read More
Regeneron has identified hundreds of coronavirus antibodies for developing treatments for COVID-19 and hopes to start clinical trials by early summer. Read More