Tricida Inc. executives were not surprised when the FDA issued a complete response letter for veverimer to treat chronic metabolic acidosis. Despite an Aug. 22 PDUFA date, the company had received an FDA notification on July 16 that there were deficiencies that would preclude discussion of labeling and postmarketing requirements and commitments.
HONG KONG –Stempeutics Research Pvt Ltd. received the green light from the Drug Controller General of India (DCGI) to launch its Stempeucel therapy to treat critical limb ischemia (CLI) due to Buerger’s disease and atherosclerotic peripheral arterial disease.
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.
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