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1 Οκτ 2024 · Recalls, Market Withdrawals, & Safety Alerts. The list below provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products. Not all...
- Enforcement Reports
FDA considers a recall to be a firm's removal or correction...
- Industry Guidance For Recalls
Public Warning and Notification of Recalls Under 21 CFR Part...
- Major Product Recalls
Recalls associated with Almark’s recall of hard-boiled egg...
- Archive for Recalls, Market Withdrawals & Safety Alerts
The Recalls, Market Withdrawals & Safety Alerts are...
- Enforcement Reports
EXANTA® (ximelagatran) Tablets NDA 21-686 FDA Advisory Committee Briefing Document 3 Development of ximelagatran The efficacy and safety of ximelagatran has been studied in a broad range of thrombogenic states in large, worldwide, comparator-controlled, and primarily outcome-based clinical studies.
The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Division of Gastrointestinal and Coagulation Drug Products has requested that AstraZeneca participate in a Cardiovascular and Renal Drugs Advisory Committee review of this application.
22 Ιουλ 2021 · This article will provide an overview of recall procedures, their impact on the pharmaceutical industry, and the various steps taken to reduce pharmaceutical recalls.
1 Οκτ 2024 · Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C Guidance for Industry and FDA Staff. Industry Recall Guidance: Product Recalls, Including Removals and Corrections ...
Exanta FDA Approval Status. FDA Approved: No. Brand name: Exanta. Generic name: ximelagatran. Company: AstraZeneca. Treatment for: Prevention of Thromboembolism in Atrial Fibrillation.
FDA provides a searchable list of recalled products. Drug recalls are actions taken by a firm to remove a product from the market and may be conducted on a firm's own initiative, by FDA...
