FDA officials discuss the status of Safe Use Initiative activities and future projects at a public workshop in November. According to the agency's website, FDA will gather input and perspectives for directions toward the development of "collaborative, cross-sector safe medication use activities with healthcare stakeholders." FDA scheduled the meeting for Nov. 16, 8:30 a.m. to 4:45 p.m. EST, and Nov. 17, 8:30 a.m. to 12 p.m., in Silver Spring, Md. FDA launched the initiative in 2008 to reduce the likelihood of preventable injury and death caused by medical errors, unintentional exposure to drugs, misuse, abuse or attempts at self-harm (1"The Tan Sheet" May 10, 2010)
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.
For the Trump Administration, the blockbuster GLP-1 drugs for obesity have become a poster child for the disparity between US and foreign prices.
Pink Sheet reporter and editors consider the issues that could emerge during upcoming private FDA forums with pharma CEOs, as well as the impact of the surprising move by HHS Secretary Robert F. Kennedy Jr. to limit the CDC recommendation for annual COVID-19 vaccine boosters.
