Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aligos, Editas, Exelixis, HHS, Kazia, Merck, Turning Point.
The U.S. Department of Health and Human Services (HHS) has ordered the FDA to cease requiring developers of lab-developed tests (LDTs) to go through the agency’s premarket review mechanisms before offering an LDT. The context of the order might at first blush be interpreted as limiting the scope of the order to the public health emergency (PHE) to the COVID-19 pandemic, but the statement expands the temporal scope by referencing a need for rulemaking on the FDA’s part, one of several indications that this order is intended to outlast the PHE.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alkermes, Astrazeneca, Biomarin, Genmab, Kazia, Miragen, Opthea, Vertex.
PERTH, Australia – An independent review of recent reforms to Australia’s Therapeutic Goods Administration (TGA) advertising framework confirmed that the changes to the new advertising code resulted in improvement, with the new code being clearer and easier to understand. The advertising reforms are part of larger regulatory reforms implemented to increase the pathways for marketing approval for drugs and devices while reducing regulatory red tape and redundancies.
The U.S. FDA has granted emergency use authorization (EUA) to Lumiradx UK Ltd. for its point-of-care SARS-CoV-2 antigen test, which aims to speed the diagnosis of people suspected of having the virus that causes COVID-19. The test detects antigen nucleocapsid protein from a nasal swab taken from symptomatic patients and delivers results in less than 12 minutes.
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