Tarmac Products, Inc. – 595993 – 09/18/2025
CGMP/QSR/Medical Devices/Adulterated
Tarmac Products, Inc. – 595993 – 11/09/2020
CGMP/QSR/Medical Devices/Adulterated
Over-the-Counter (OTC) Drug Review | OTC Monograph Reform in the CARES Act
Information about Over-the-Counter (OTC) Monograph Reform
Key Information about Nonprescription, Over-the-Counter (OTC), Oral Phenylephrine
Information for consumers related to oral phenylephrine as an active ingredient in nonprescription drugs used to alleviate symptoms of cold,…
OTC Drug Review Process | OTC Drug Monographs
The Over-the-Counter (OTC) Drug Review was established to evaluate the safety and effectiveness of OTC drug products marketed in the…
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