E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports
E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports
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M14 General Principles on Planning, Designing, Analyzing, and Reporting of Non-interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines
M14 General Principles on Planning, Designing, Analyzing, and Reporting of Non-interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines -
New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers
New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers -
Field Safety Notices: 23-27 February 2026
List of Field Safety Notices from 23-27 February 2026.
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NDA and BLA Calendar Year Approvals
NDA and BLA Calendar Year Approvals -
Efficacy Supplement Approvals
Efficacy Supplement Approvals -
FDA Adverse Event Reporting System (FAERS) Public Dashboard
Four FAERS summary statistics reports updated with data through December 31, 2013. -
Savannah Bee Company Recalls Honey BBQ Sauce-Mustard Due to Undeclared Wheat and Soy
SAVANNAH, GA 2-27-2026 – Savannah Bee Company is recalling their HONEY BBQ SAUCE- MUSTARD, 16FL OZ B1L1360525 Best Before 05/16/27 UPC 8 50033 93758 9 due undeclared wheat and soy. People who have an allergy or severe sensitivity to wheat or soy run the risk of serious or life-threatening allergic r -
USA LESS Co. is Recalling Rhino Choco VIP 10X Due to Undeclared Tadalafil
BROOKLYN, N.Y., Feb. 27, 2026 /PRNewswire/ — USALESS.COM is recalling its RHINO CHOCO VIP
10X, in 10 gr, 12 pc packages that come in a black cardboard box marked with UPC Code 724087947668 on the back and with an expiration date of 10/2027 stamped on the back. The product is sold in retail stores a -
Medicines: reclassify your product
Pharmacy (P), prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
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MHRA statement on Pathways clinical trial
As with all clinical trials, the MHRA’s top priority is the safety and wellbeing of the trial participants.
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Certification Process for Designated Medical Gases
This guidance explains how FDA administers the certification process and describes the annual reporting requirements for designated medical gases (DMGs).