Drug recall information for consumers, health care professionals and industry
drug recalls page, FDA’s role
FDA Publishes Filing Checklists to Prevent Submission Delays
The U.S. Food and Drug Administration today made public filing checklists used internally by Center for Drug Evaluation and Research…
Fosfomycin Injection
Fosfomycin Injection
FDA Rationale for Recognition Decision: Gentamicin, Tobramycin, and Amikacin for Enterobacterales and P. aeruginosa
FDA has completed its review of the rationale document titled, “Aminoglycoside Breakpoints for Enterobacterales and Pseudomonas aeruginosa” submitted by the…
Gentamicin – Injection products
Gentamicin – Injection products;
Tobramycin – Injection products
Tobramycin – Injection products
Distinguishing Between Oral and Transdermal Administration Routes of Methyltestosterone Through Human Urine and Dried Blood Spot Analyses for Doping Control Purposes
This study aimed to evaluate whether it is analytically possible to distinguish the transdermal absorption of methyltestosterone from oral administration. The…
Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers
Significant changes from the 2017 version include additional recommendations related to IRB review; informed consent, including a template; and new…
Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments
This guidance is the third in a series of four methodological patient-focused drug development guidances that describe how stakeholders can…
Guidance Recap Podcast | Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments
Guidance Recap Podcast: Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments