by David McConkey | Mar 16, 2023 | FDA Approvals, FDA Public Information, Industry News, New Drugs, New Pharma Products, Pharmaceuticals, Product-Innovation, US-FDA
Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact The U.S. Food and Drug Administration (FDA) on December 22, 2022 announced the approval of a new HIV drug called...
by Devices and Pharma | Mar 12, 2023 | Consumer Information, FDA Enforcement, FDA Warning letters, Industry News, Pharmaceuticals, US-FDA
Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Warning Letter Sites Violations of Law In early February of this year, the U.S. Food and Drug Administration (FDA)...
by David McConkey | Mar 8, 2023 | Consumer Information, FDA Approvals, FDA Public Information, Industry News, Med-Devices, New devices, Product-Innovation, US-FDA
Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact The Food and Drug Administration (FDA) on 12 December 2022 announced the approval of Agilent’s Resolution CTDX...
by David McConkey | Mar 6, 2023 | Consumer Information, FDA Approvals, FDA Public Information, Industry News, New Drugs, New Pharma Products, Pharmaceuticals, Product-Innovation, US-FDA
Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact The US Food and Drug Administration (FDA) announced on 06 January, 2023 that it had granted accelerated approval for...
by Devices and Pharma | Mar 1, 2023 | Alerts, FDA Enforcement, FDA Warning letters, Industry News, Med-Devices, US-FDA
Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Identifies several violations of the FD&C Act and QSR On February 7, FDA issued a warning letter it had sent to...
by Devices and Pharma | Mar 1, 2023 | Alerts, Consumer Safety, FDA Public Information, Industry News, Med-Devices, Product Safety, US-FDA
Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Letter outlines risks associated with the heart valve On February 27, the FDA released a letter to healthcare...