In a draft guidance released May 9, the U.S. FDA described the benefit-risk principles it uses when conducting quality-related assessments of chemistry, manufacturing and controls (CMC) information submitted as part of a new drug application, biologics license application or supplement.
Even though at least two different U.S. district courts have ruled that the 340B enforcement letters the Department of Health and Human Services’ (HHS) Health Resources and Services Administration has sent to biopharma companies violate the Administrative Procedures Act, the agency continues to send the letters, along with threats of civil money penalties, to companies that place restrictions on the 340B discounts to contract pharmacies.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cvrx, Lucira Health, Philips.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Johnson & Johnson, Myovant, Pfizer.
Nano-x Imaging Ltd.’s (Nanox) subsidiary Nanox.AI has received the FDA’s 510(k) clearance for Healthost, an artificial intelligence (AI) software device providing qualitative and quantitative analysis of the spine from CT scans.
A risk of rare but potentially life-threatening blood clots in combination with low platelet levels after a jab of Johnson & Johnson's Janssen COVID-19 vaccine has convinced the U.S. FDA to limit its use. The vaccine is now authorized in the U.S. only for adults who wouldn't otherwise be vaccinated and those who can't or shouldn't, for medical reasons, get another approved vaccine. Through March 18, 2022, the FDA and CDC have identified 60 confirmed cases, including nine fatal cases of the condition, called thrombosis with thrombocytopenia syndrome – a rate of 3.23 cases per million doses of vaccine administered.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Bio Products, Daiichi, Incyte, Jiangsu Recbio, Kempharm, Moleculin, Newsoara, Palisade, Vistagen, Xortx.
Mark it as a day to remember. The U.S. FDA has awarded de novo marketing authorization for the first in vitro diagnostic (IVD) test for Alzheimer’s disease (AD), enabling diagnosis of the dreaded disease years earlier than current clinical tests. Fujirebio Diagnostics Inc.’s Lumipulse G β-Amyloid Ratio (1-42/1-40) measures specific proteins in cerebral spinal fluid to provide rapid assessment of the risk of amyloid plaques, an indicator of the disease that may develop decades before cognitive impairment occurs.
When it comes to innovation, Europe has a thing or two it can learn from the U.S. according to European leaders. Speaking at the Medtech Forum meeting in Barcelona, Medtech Europe CEO Serge Bernasconi said Europe’s focus on safety issues is stifling innovation across the continent.
The legislation that would reauthorize the U.S. FDA’s user fee programs is now in the works in the House of Representatives, but the legislation is fairly lean when considering the number of issues facing the agency.
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