FDA Agrees With GAO Recommendations To Give Prosecutions Higher Priority
FDA's plans to increase prosecutions of noncompliant food and drug industry officials, as recommended by an internal committee, should include the dietary supplement market, stakeholders say
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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.’
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The use of J&J’s Darzalex Faspro in high-risk smoldering multiple myeloma could result in overtreatment, but the FDA committee voted in favor of the new claim for delay in development of multiple myeloma.
The glofitamab trial results are not generalizable due to the small number of enrolled US lymphoma patients and adverse results across multiple endpoints for patients from non-Asian regions, the Oncologic Drugs Advisory Committee said.
The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.