Αποτελέσματα Αναζήτησης
3 Ιουλ 2024 · The FDA approved a new drug from Eli Lilly, which will be sold under the brand name Kisunla, that has shown to modestly slow a decline in memory loss and thinking abilities for people with ...
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The FDA uses postmarket requirement and commitment studies to gather additional information about a product's safety, efficacy, or optimal use. New Drug Application (NDA)--This is the...
The table below lists all official FDA Guidance Documents and other regulatory guidance. You can search for documents using key words, and you can narrow or filter your results by product,...
9 Σεπ 2024 · Yes. The proposed rule introduces Patient Medication Information or PMI. This would be a new type of Medication Guide that would require FDA approval. Specifically, the proposed rule, if finalized ...
16 Φεβ 2017 · Over the past 5 years, the FDA has approved 182 new drugs. This overview explains the FDA’s drug-approval process, including its approach to benefit–risk assessment, drug labeling, risk...
