FDA outlines new GMP rules for Medical Gases IMPORTANT CHANGES Please take notice FDA came out with a new proposed rule for certain Medical Gases titled “Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases.”. FDA estimates this ruling will affect approximately 1,696 firms in the medical gases industry
More and more drugs are being compounded by compound pharmacies. The FDA does regulate compound pharmacies and periodically these companies and drugs run into a problem that require a recall. FDA is alerting patients, health care professionals, veterinarians, and animal owners/caretakers about a voluntary recall by Drug Depot, LLC, doing business as APS Pharmacy, of
FDA Update The FDA Continues to Streamline their Process As They Announce Minor Updates to Refuse to Accept Policy for 510(k)s – Final Guidance Helps to Clarify What Is Acceptable to the FDA On April 25, 2022 the U.S. Food and Drug Administration (FDA) updated the 2019 final guidance: Refuse to Accept Policy for 510(k)s.
Finally it is recognized that racial and ethnic diversity are more than skindeep as the FDA takes important steps to increase diversity in clinical trials. Agency’s Focus on Inclusion in Trials for All Medical Products Aligns with Biden Administration’s Cancer Moonshot Goal of Addressing Inequities and Beyond. The U.S. Food and Drug Administration issued a
FDA Warns – OTC Skin Lightening Products Can Cause Potentially Harmful and Irreversible Side Effects mdi like to provide updates on various FDA situations showing how the FDA follows up with sending out multiple warning letters on a specific situation. Here is a recent case of 12 companies promoting the same product. FDA issued warning letters to
New medical technologies are always being developed to make things easier. Here is a new Covid test that would make things a lot easier for determining the presence of Covid. The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to InspectIR Systems for their InspectIR COVID-19 Breathalyzer test. The InspectIR COVID-19
A lot is going with the covid testing. And the FDA is taking a closer look to all the test kits on the market. Here are the results of one such FDA testing the “TESTS”. Not All COVID-19 Test Kits are Created Equal. FDA Warning… Do Not Use SD Biosensor STANDARD Q COVID-19 Ag Home
The FDA has been deciding on how to work the ISO 13465-2016 into the QSR for many years. The covid situation has put this process on hold, but it is appears it is now back on the agenda. These changes are supposed to make the FDA QSR more in line with the ISO standard. The
Sanitation Tunnels for COVID-19 Disinfection Not Encouraged by FDA These times have lent themselves to some crazy Covid prevention devices and treatment. Here is one that the FDA feels should not be used. The U.S. Food and Drug Administration issued a guidance for industry and investigators titled “COVID-19 Public Health Emergency: Policy on COVID-19-Related Sanitation
FDA Update February 10, 2022 Warning – FDA could be knocking on your door! The FDA Restarts Routine Domestic Surveillance Inspections With the decline of Covid-19 cases across the country, the FDA has decided to re-start their routine domestic surveillance inspections in the US. The FDA will also resume their foreign surveillance inspections provided that
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