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...
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...
Oct 12, 2021 | Cosmetics, Drugs
Did you know that products designed to clean and beautify that ALSO affect the structure or function of the human body must bear special labeling? Per FDA’s 21 USC 359, these combination cosmetic – OTC Drug products must comply with OTC drug monographs and bear “Drug...
