U.S. Food and Drug Administration
The U.S. Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. The FDA is responsible for regulating products within the U.S. such as human drugs, medical devices, vaccines, blood products, radiation emitting products, and most food products. The AANA monitors FDA activities and regulations which may affect CRNA practice or the products and devices that CRNAs utilize.Bupivacaine Shortage Information and Resources
- AANA
- Considerations for Management of Bupivacaine Formulation
Shortage Affecting Obstetric Anesthesia Services, August 2018 - Safe Injection Guidelines for Needle and Syringe Use
- USP Chapter 797 and Anesthesia Practice
- Considerations for Management of Bupivacaine Formulation
- American Society of Health-System Pharmacists (ASHP)
- Centers for Disease Control and Prevention (CDC)
- U.S Food and Drug Administration (FDA) Bupivacaine Drug Shortage Detail
Shortages, Recalls, and Safety Alerts
- Anesthesia Specific Drug Shortages, Drug and Device Recalls, and Safety Alerts (Login Required)
- General FDA Information
Recent FDA News
- FDA alerts health care professionals and patients not to use compounded drugs from Cantrell Drug Company; agency seeks action to stop production and distribution, March 1, 2018
- FDA Launches Adverse Events Reporting System Public Dashboard, September 29, 2017
- FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: careful medication management can reduce risks, September 20, 2017
- FDA - Information about the Use of Forced Air Thermal Regulating Systems - Letter to Health Care Providers, August 30, 2017
- Timeline of Selected FDA Activities and Significant Events Addressing Opioid Misuse and Abuse, August 29, 2017
- FDA requests removal of Opana ER (oxymorphone hydrochloride) from the market for risks related to abuse, June 8, 2017
- FDA approves label changes for use of general anesthetic and sedation drugs in young children, April 27, 2017
- FDA warns about rare but serious allergic reactions with the skin antiseptic chlorhexidine gluconate, February 2, 2017
- Safety concerns with implantable infusion pumps in the Magnetic Resonance (MR) Environment, January 11, 2017
AANA Comment Letters to FDA
- AANA submits comment letter to the FDA's Opioid Policy Steering Committee regarding prescribing intervention strategy implementation, March 13, 2018
- AANA submits comment letter to FDA supporting a multidisciplinary patient-centered approach to provider education on pain management and safe opioid use, July 10, 2017
- AANA submits comment letter to the FDA regarding the use of prescription opioids analgesics for the pediatric population, September 30, 2016
- AANA submits comment letter to FDA regarding the ER/LA Opioid Analgesics REMS Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics, June 3, 2016
- AANA supports FDA's proposed powdered glove ban to mitigate the adverse events related with these devices and promote patient and healthcare worker safety, May 9, 2016
- AANA submits comments to FDA regarding labeling of injectable medical products in multi-dose, single-dose, and single-patient-use containers, December 21, 2015
- AANA submits comments to FDA regarding patient involvement and input in the medical device lifecycle and engagement and integration of patient preference data into device research and communication with the patient, November 18, 2015
- AANA submits comments to FDA regarding patient involvement and input in the medical device lifecycle and engagement and integration of patient preference data into device research and communication with the patient, November 5, 2015
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