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From Our Perspective: OMUFA – Past, Current, and Future

The OTC Monograph drug user fee program, which we refer to as “OMUFA,” is similar to our other user fee…

Prevalence of AAS‐Positive Samples at Drug Abuse Laboratory Sweden Between 2014 and 2023 and Sub‐Study of Dual Use of AAS and Narcotics

Throughout 2014–2023, over 20,000 AAS analyses have been conducted at the drug of abuse laboratory, Karolinska University Hospital. Approximately 20%…

Prevalence of AAS‐Positive Samples at Drug Abuse Laboratory Sweden Between 2014 and 2023 and Sub‐Study of Dual Use of AAS and Narcotics

Throughout 2014–2023, over 20,000 AAS analyses have been conducted at the drug of abuse laboratory, Karolinska University Hospital. Approximately 20%…

PDUFA VII Commitment: An Assessment of the Sentinel System (2022 to 2024)

PDUFA VII Commitment: An Assessment of the Sentinel System (2022 to 2024)

FDA-TRACK: Biosimilar User Fee Act Procedural Response Goals Summary

FDA-TRACK: Biosimilar User Fee Act Procedural Response Goals Summary

Media Networks Sydney Pty. Limited – 711342 – 09/16/2025

Failure to Comply with Drug Listing Requirements/Misbranded

Flexi Bion may be harmful due to hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Flexi Bion, a product promoted and sold…

Piperacillin – Injection Products

Piperacillin – Injection Products

Sleep, Skin, Bodybuilding and Other Product Notifications

Learn about the warnings for sleep, skin and bodybuilding products that contain hidden drugs and other hidden ingredients.

Agebox iKids Growth Night Formula may be harmful due to hidden ingredient

FDA laboratory analysis confirmed that Agebox iKids Growth Night Formula contains ibutamoren not listed on the product label.