CDER Statement
[3-11-2024] Today, FDA issued a revised draft guidance, Early Alzheimer’s Disease: Developing Drugs for Treatment Guidance for Industry. Once finalized, the guidance will provide recommendations to help drug companies developing medicines to treat patients with early...CDER Statement
[03/13/2024] EUA-labeled Paxlovid is no longer authorized for emergency use, regardless of the labeled or extended expiration date. For both NDA-approved and EUA-authorized uses, only NDA-labeled Paxlovid may be dispensed. Today’s revision to the Paxlovid EUA...FDA approves safety labeling changes for opioid pain medicines
[12/15/2023] Today, FDA is announcing final approval and implementation of required labeling updates to continue efforts to address the evolving opioid crisis, and to urge health care professionals to take a more patient-centered approach when prescribing opioid...Blaine Labs, Inc Issues Voluntary Nationwide Recall of Wound Care Gel Products Due to Microbial Contamination
Summary Company Announcement Date: April 08, 2026 FDA Publish Date: April 08, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Products were found to contain Lysinibacillus fusiformis, an environmental organism Company Name: Blaine Labs,...All Drug Purchases Are
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