Internet information is not necessary for the proper use of foods, dietary supplements or drugs, and should therefore be classified as advertising, the Washington Legal Foundation maintains in a citizen petition submitted to FDA April 13.
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ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.
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.
