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...
Jan 12, 2022 | Medical Devices, Webinar
U.S. FDA’s Latest Requirements for the 510(k) Presented by John Lincoln, EAS Independent Consultant April 19, 2022 at 1pm eastern The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process, others are exempt, and...
Dec 21, 2021 | Medical Devices, Webinar
Medical Device Product Risk Management Presented by John Lincoln, EAS Independent Consultant February 28, 2022 at 1pm eastern Both the U.S. FDA and the EU’s MDR require product risk management as part of virtually all regulatory compliance efforts. Companies...
Dec 21, 2021 | 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 Cover Letter Attachments for...
Nov 19, 2021 | Drug and Device Corner, Drugs, Medical Devices
Final reminder that we are entering the last month of the registration renewal period for medical device facilities and drug establishments, as well as drug listing certifications. The FDA has provided an Electronic Drug Registration and Listing Instructions website...
Oct 27, 2021 | Drug and Device Corner, Drugs, Medical Devices
REMINDER that we are in the renewal period for all drug establishment, and medical device facility registrations, as well as the drug listing certification period. The agency announced this month their intention to withdraw the Temporary Guidances for Alcohol-Based...
