FDA update RE: FDA Announces the Availability of a Proposed Rule: Revising the National Drug Code Format and Drug On July 22, 2022, FDA announced the availability of a proposed rule to adopt a single, uniform 12-digit format (a universal 6-4-2 format) for FDA-assigned NDCs. In addition, the FDA proposes to revise the label requirements
FDA Update PATIENT LABELING for HUMAN Rx and Biological Products Patients and Caregivers Alike Can Finally Rely on Clear Usage Instructions for Prescription and Biological Drugs as the FDA Issues Final Guidance on Instructions for Use Documents The U.S. Food and Drug Administration has issued a final guidance, “Instructions for Use – Patient Labeling for
FDA Update “Put Down the Wand” FDA Warns Against the Use of Certain Ultraviolet (UV) Wands That Give Off Unsafe Levels of Radiation Periodically what seems like a good idea goes awry. During the pandemic everyone was looking to keep all surfaces including hands disinfected. One method of disinfecting surfaces was the use of a
FDA Update According to the FDA a Permanent Solution to the Baby Formula Supply Chain Shortage is On the Way A baby formula problem caused by the FDA is that same FDA that is now trying to fix it. As usual, our REACTIVE government came up short in anticipating a problem and did not offer
FDA Update FDA Request for Advisory Committee Nominations: Consumer Organizations and Individuals The Food and Drug Administration seeks input from consumers on medical and scientific issues. A key method of ensuring that FDA obtains the points of view of consumers is by including Consumer Representatives on Agency advisory committees. The FDA, relies on their many
Further Protection Against Counterfeit, Stolen, Contaminated, or Otherwise Harmful Drugs is On the Way FDA is announcing the availability of two guidances to help trading partners comply with the Drug Supply Chain Security Act (DSCSA). These documents are critical steps toward implementing the DSCSA enhanced drug distribution security requirements that will go into effect on
IMPORTANT 30-DAY NOTICE FOR FSVP IMPORTERS RE: “UNK” Food Importer News from the U.S. FDA Center for Food Safety and Applied Nutrition NEW for food importer – Beginning July 24, 2022, the entity identification code “UNK” will no longer be accepted in the Entity Number field by U.S. Customs and Border Protection (CBP). Consistent with
FDA Update – PULSE OXIMETERS The FDA has some concerns on the precision on Pulse Oximeters when it is used by people of different skin tones. They recently came out with this update. Can Skin Tone Affect the Precision of Pulse Oximeters? The FDA is Working to Determine the Accuracy As Well As Limitations The
FDA Update Periodically the FDA issues Guidance documents for 510(k) submissions. here is a recent one for Radiological devices. FDA Issues Final Guidance about Technical Performance Assessments for Quantitative Imaging in Premarket Submissions The U.S. Food and Drug Administration (FDA) issued the final guidance, Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions. This
We knew this would be happening at some time and it appears that it will next month – the EUA will end. As the COVID-19 Crisis Returns to Pre-Pandemic Levels… FDA Intends to Withdraw Final Guidance: Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices – Questions
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