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Working to Reduce Medication Errors | FDA
- https://www.fda.gov/drugs/information-consumers-and-patients-drugs/working-reduce-medication-errors
- The reports come from drug manufacturers, and healthcare professionals and consumers through MedWatch, the Agency's safety information and adverse event …
FDA Mistakes: 7 Drugs That Shouldn't Have Been Approved
- https://allthatsinteresting.com/fda-mistakes
- Here are just a few disastrous FDA mistakes that unleashed harmful drugs into the market. FDA Mistakes: Quaaludes Image Source: Newsweek Quaaludes were a sedative and …
How FDA Failures Contributed to the Opioid Crisis
- https://journalofethics.ama-assn.org/article/how-fda-failures-contributed-opioid-crisis/2020-08
Medication Errors Related to CDER-Regulated Drug …
- https://www.fda.gov/drugs/drug-safety-and-availability/medication-errors-related-cder-regulated-drug-products
- The reporting of medication errors to FDA’s Adverse Event Reporting System (FAERS) is voluntary in the United States, though FDA encourages healthcare providers, …
Medical Devices | FDA - U.S. Food and Drug Administration
- https://www.fda.gov/Medical-Devices
- FDA Issues Two Warning Letters to Leading Manufacturer of Endoscopes CDRH recently issued two warning letters to a leading manufacturer of endoscopes, Olympus Medical …
2022 Medical Device Recalls | FDA - U.S. Food and …
- https://www.fda.gov/medical-devices/medical-device-recalls/2022-medical-device-recalls
- 11/01/22. Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices. 10/18/22. Jiangsu …
MedWatch: FDA Safety Information & Adverse Event …
- https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program
- MedWatch, the FDA’s medical product safety reporting program for health professionals, patients and consumers. Report a Problem Safety Information Stay Informed MedWatch …
Medical Device Common Entry Errors | FDA
- https://www.fda.gov/industry/common-entry-submission-errors/medical-device-common-entry-errors
- To expedite entry screening of medical device products by the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) system, …
Examples of Medical Device Misconnections | FDA
- https://www.fda.gov/medical-devices/medical-device-connectors/examples-medical-device-misconnections
- The IV tubing was mistakenly connected to the trach cuff port The IV fluid over-expanded the trach cuff to the point of breaking and continuous IV fluids entered the …
Risky Drugs: Why The FDA Cannot Be Trusted
- https://ethics.harvard.edu/blog/risky-drugs-why-fda-cannot-be-trusted
- The New England Journal of Medicine has published, without comment, proposals by two senior figures from the FDA to loosen criteria drugs that allege to …
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