USPS Ground Advantage volume jumps as shipping changes take root
The Postal Service has secured more direct customer contracts as volume for services used by package consolidators wanes.
GDUFA Type II API DMF Payment Receipts Report
GDUFA Type II API DMF Payment Receipts Report
October 29, 2024: Meeting of the Pharmacy Compounding Advisory Committee – 10/29/2024
This meeting is scheduled to start at approximately 8 a.m. Eastern Time and will be held at FDA White Oak…
Tri-Union Seafoods Issues Recall of Select Genova®, Van Camp’s®, H-E-B and Trader Joe’s® Tuna Cans Due to Clostridium Botulinum Risk
Tri-Union Seafoods has made the decision to voluntarily recall select lots of canned tuna products sold under the Genova®, Van…
De minimis exemption temporarily returns for products from China
Duty-free treatment for sub-$800 products will end again once systems are put in place to collect tariff revenue more effectively,…
HIPAA Security Section 312 Changes
Earlier this week I provided a side-by-side comparison of the HIPAA section 308 changes. Today I have a similar sheet…
Aztreonam and Avibactam Injection
Aztreonam and Avibactam Injection
Notice of Updates
Webpage providing notices of updates to FDA’s STIC webpages for antibacterial and antifungal drugs.
GM weighs production shifts, sourcing reviews to mitigate tariffs
CFO Paul Jacobson said it has multiple playbooks to help offset the impact of higher costs throughout its supply chain.
Public Meeting on the Recommendations for the Over-the-Counter Monograph Drug User Fee Program (OMUFA) Reauthorization – 11/20/2024 – 11/20/2024
The Food and Drug Administration (FDA or Agency) is announcing a hybrid public meeting to discuss proposed recommendations for the…