We want to keep our clients up to date as we learn of any changes at the FDA that will affect normal business processes.
The following 3 points have come to our attention in the last few days.
- For any questions regarding the status of a product in the NDC Directory, you may access downloadable NDC database files available at the bottom of the National Drug Code Directory Currently, the searchable site is not being updated, but the downloadable files are current. Please see screen shots below to download the correct database for research. If the NDC appears in the downloadable file, it is the equivalent of the NDC appearing in the NDC Directory searchable site.
- CDER Ombuds services are currently unavailable at the Food and Drug Administration.
We have learned of an unannounced FDA drug facility inspection in Canada. We do not have further details on whether the FDA anticipates continuing this practice and whether it will extend beyond Canada to other international sites.
Drug Database download instructions:
We will keep you informed as changes come to our attention. Do not hesitate to reach out with any questions.
Posted in Cosmetics, Drug and Device Corner, Drugs, Medical Devices.