![]() ![]() botulinum containment measures and lax environmental monitoring practices following observed during an inspection in August 2021. The agency also released a Form 483 handed to South Korean drugmaker Hugel, Inc., noting several good manufacturing practice (GMP) issues, including inadequate C. for the company’s sabizabulin oral capsule to treat SARS-CoV-2 infection in patients with moderate to severe COVID-19 with a high risk of acute respiratory distress syndrome (ARDS). ![]() On Wednesday, FDA announced it will convene its Pulmonary-Allergy Drugs Advisory Committee on 6 October to discuss an emergency use authorization (EUA) request from Veru Inc. The first submission accepted to the program “is for a tool that proposes to evaluate off-target protein binding for a variety of biotherapeutic modalities, potentially reducing or eliminating the need to conduct some of the more standard nonclinical toxicology tests.” The pilot, launched nearly two years ago, is meant to promote the development of new drug development tools (DDTs) that fall outside the agency’s existing DDT qualification programs. ![]() FDA noted that the reports are different from breast implant associated anaplastic large cell lymphoma (BIA-ALCL).įDA’s drug and biologics centers on Wednesday said they have accepted the first submission to the agency’s Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot. In a safety communication sent on Thursday, the agency said that the occurrence of SCC and lymphomas in the tissue around breast implants is rare, though it is alerting the public to those risks out of an abundance of caution. We also saw FDA warn of the risk for squamous cell carcinoma (SCC) and certain lymphomas in scar tissue around breast implants. Read more from Stat and The Wall Street Journal. At the outset of the hearing, Billy Dunn, director of FDA’s Office of Neuroscience, called on the company to pledge to withdraw the drug, if approved, if its ongoing confirmatory found it to be ineffective. FDA delayed its decision and reconvened its advisory committee to review the new data. After the committee voted 6-4 against the drug’s approval in March, Amylyx went to FDA with new analyses showing the drug could increase survival by 10 months, along with biomarker data from a Phase II study in Alzheimer’s disease. This week, we also saw an FDA advisory committee reverse its position on Amylyx’s amyotrophic lateral sclerosis drug, voting 7-2 in favor of approving the drug based on new analyses and data from a study of the drug to treat Alzheimer’s disease. One potential path for user fee reauthorization: strapping the user fee package to a continuing resolution that will likely be passed in lieu of a full-year appropriations bill, Roll Call reports. The agency has said it can use carryover funds from the current user fee programs into November to delay notifying staff of impending layoffs. With Congress back in session and the end of the fiscal year rapidly approaching, attention once again turns to user fee reauthorization and appropriations.īoth Politico and BioCentury reported this week that an FDA spokesperson said the agency has a “reasonable expectation” that its user fee programs will be reauthorized before it needs to lay off any user fee-funded staff. Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. ![]()
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