CPSC CRP TESTING LESS LIKELY WITH COMPANY DATA ON FILE, Consumer Product Safety Commission Project Manager Suzanne Barone, PhD, said at a Feb. 13 Nonprescription Drug Manufacturers Association and Pharmaceutical & Medical Packaging News workshop in Somerset, N.J. Noting that CPSC has "limited funds" for testing marketed child-resistant packaging, Barone explained that companies that voluntarily submit their own passing CRP data to CPSC are not likely to be subject to commission testing unless difficulties come to light through consumer complaints or adverse events.
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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.
