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The committee agreed that the company’s trial data showed the drug to be effective and that it adequately addressed the potential risk of cardiovascular adverse events. Read More
The FDA cited an API manufacturing facility in Torrance, California, for deficiencies in quality assurance, preventive maintenance, audits and batch records. Read More
The FDA issued draft guidance Wednesday that outlines what the agency considers an ideal and robust verification system to be that’s also in line with legislative requirements. Read More
President Trump signed a massive anti-opioid legislative package Wednesday and gave an update on the administration’s efforts to deal with the opioid addiction crisis. Read More
The FDA teamed up with international regulators and law enforcement agencies to target illegal online distributors that sold unapproved versions of opioid, antiviral and oncology drugs to the U.S. Read More
FDA Commissioner Scott Gottlieb said the agency is considering ways to increase the availability of the opioid overdose drug naloxone, including expanded over-the-counter access. Read More