FDA

FDA Acknowledgment Letter to North Bay Productions

The FDA's Division of Management and Budget (DMB) issued an acknowledgment letter to North Bay Productions on March 13, 2026. This notice confirms receipt of a submission from the company.

Strattera Oral Solution SMPC Posting

The FDA has posted the Summary of Product Characteristics (SMPC) for Strattera oral solution on March 13, 2026. This posting provides updated information regarding the drug's characteristics and usage. It is intended for informational purposes for drug manufacturers and healthcare professionals.

Draft Labeling for Atomoxetine HCL Solution

The FDA has posted draft labeling for Atomoxetine HCL Solution for public comment. This document outlines proposed changes to the drug's labeling, which will impact manufacturers and potentially healthcare providers.

FDA Streamlines Biosimilar Development Guidance

The FDA issued draft guidance to streamline biosimilar development by recommending the reduction of unnecessary clinical pharmacokinetic testing when scientifically justified. This initiative aims to save developers up to 50% in PK study costs, potentially lowering drug prices and increasing patient access to affordable biologic treatments.

FDA Approves Wellcovorin for Cerebral Folate Deficiency

The FDA has approved Wellcovorin (leucovorin calcium) tablets for the treatment of cerebral folate deficiency in adult and pediatric patients with a confirmed FOLR1 gene variant. This marks the first FDA-approved treatment for this rare genetic condition.

FDA Launches Unified Adverse Event Analysis Platform AEMS

The FDA has launched a new unified platform, the Adverse Event Monitoring System (AEMS), to analyze adverse event reports for all regulated products. This modernization aims to improve data accessibility, transparency, and surveillance capabilities, replacing fragmented legacy systems and is expected to save $120 million over five years.

FDA Approves Tec-Dara for Relapsed Multiple Myeloma

The FDA has approved Tec-Dara (teclistamab and daratumumab hyaluronidase-fihj) for relapsed or refractory multiple myeloma. This approval was granted under the Commissioner's National Priority Voucher (CNPV) pilot program, marking a significant acceleration in the review process.

FDA Meeting on State Drug Importation Program

The FDA held a meeting with several states to discuss the Section 804 Importation Program (SIP), which allows states to import certain prescription drugs from Canada. This meeting is part of the FDA's implementation of an executive order aimed at lowering drug prices for American consumers.

Lidl US Recalls Chocolate Ladybugs Due to Undeclared Hazelnut

Lidl US is recalling all lots of Favorina Chocolate Ladybugs - German-Style Nougat due to undeclared hazelnut allergen. The product was distributed to Lidl US stores in several East Coast states between January and March 2026. Consumers with hazelnut allergies are at risk of serious reactions.

Insulet Recalls Omnipod 5 Pods Due to Manufacturing Issue

Insulet Corporation is initiating a voluntary medical device correction for specific lots of Omnipod 5 Pods due to a manufacturing issue that may cause insulin leaks. The FDA has been notified of this action, which impacts approximately 1.5% of global production. Customers can check lot numbers online and request replacement pods.