Jul 6, 2022 | Drug and Device Corner, Drugs, Medical Devices
The FDA is tightening up the validation process in their NDC drug listing system CDER Direct. Prior to 2022, Relabelers and Repackers were able to list their products NDC/label without identifying the source NDC. As of 2022, the drug listing of a repackaged or...
May 26, 2022 | Drug and Device Corner, Drugs, Medical Devices
The passing of the CARES Act in 2020, built on the authorization given to FDA in 2012 by the Food and Drug Administration Safety and Innovation Act (FDASIA), to address the problem of drug supply disruptions and shortages. The agency released a draft guidance to...
Apr 19, 2022 | Drug and Device Corner, Drugs, Medical Devices
We are 5 months out from the UDI / GUDID enforcement date of 22 September 2022 for Class I and unclassified devices, are your processes in place? Do you know what requirements are applicable to your operation? Helpful information can be found on FDA’s webpage GUDID...
Mar 21, 2022 | Drug and Device Corner, Drugs, Medical Devices
FDA announced the fiscal year 2022 OTC-Monograph Drug User Fee rates in the Federal Register Vol 87, No 51 published today 16 March 2022. These fees cover FDA’s FY2022 which runs from October 2021 through September 2022. The facility fees for FY 2022 are due on 1 June...
Feb 22, 2022 | Drug and Device Corner, Drugs, Medical Devices
FDA’s New Draft Rule: “Medical Devices; Quality System Regulation Amendments” On February 22, 2022, FDA published a proposed rule that aims to harmonize the current Quality System Regulation for Medical Devices under 21 CFR part 820 with international standards, ISO...
Jan 24, 2022 | Drug and Device Corner, Drugs, Medical Devices
Reminder: CARES Act Drug Shortage Mitigation Efforts reporting deadlines Reports for calendar year 2020 should be submitted no later than 15 February 2022 Reports for calendar year 2021 should be submitted no later than 16 May 2022 For application holders filing eCTD...
