Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Kheiron Medical Technologies, Letsgetchecked, Liquiglide, Livanova.
Health Canada is proposing amendments to the Food and Drugs Act that would provide greater oversight of the manufacture of drugs for export. Currently, facilities that manufacture or prepare drugs in Canada for use outside the country are not required to obtain a drug establishment license or to follow Canadian requirements for good manufacturing practices, and they are exempt from fees.
After delaying it twice, the U.S. Department of Health and Human Services (HHS) is proposing to rescind a Trump-era rule that would have given certain low-income patients insulin and injectable epinephrine products at the steeply discounted 340B rate.
Noticeably lacking in the G7 communique following its recent U.K. summit is support for a proposed World Trade Organization waiver on intellectual property related to drugs and other medical products used to prevent, contain or treat COVID-19 infections.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alx, Amylyx, Ascendis, Avenue, Enochian, GBT, Gesynta, Humanigen, Istari, Jasper, Lipocine, Moderna, Sorrento, Tilt.
The FDA’s multiyear effort to rewrite the Quality System Regulation (QSR) to align with ISO 13485 could significantly ease the regulatory burden for device makers in multiple markets, but that effort has floundered over the past couple of years. The associated rulemaking is back on the FDA’s agenda, signaling that device makers might soon be able to deploy a single and relatively inexpensive quality management system, which in principle would significantly reduce their compliance costs.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Exthera Medical, Icad, Quidel.
The U.S. isn’t the only country tossing COVID-19 vaccines due to potential cross-contamination of the drug substances manufactured at an Emergent Biosolutions Inc. plant.
Biogen Inc.’s pricing of its newly approved Alzheimer’s drug, Aduhelm (aducanumab), has made it the latest bull’s eye for lawmakers and advocacy groups targeting U.S. drug prices, especially given the controversy surrounding the drug’s approval, which has resulted in the resignation of three of the 11 members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Gilead, Incyte, Kyowa Kirin, RDIF, Rhovac, Vicore.
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