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Correction: Vol. 31, No. 2

by | Mar 26, 2025 | News

Correction: Vol. 31, No. 2 Volume 31, Number 5—May 2025 Altmetrics Click a source for Altmetric details What is the Altmetric Attention Score? The Altmetric Attention Score for a research output provides an indicator of the amount of attention that it has received....

BPI Labs, LLC – 699533

by | Mar 26, 2025 | News

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Chandra Kasireddy Recipient Title Chief Operating Officer BPI Labs, LLC 12393 S Belcher Road Ste 450Largo, FL 33773United States chandrak@belcherpharma.com Issuing Office: Center for Drug Evaluation...

Americo F. Padilla, M.D. – 700447

by | Mar 26, 2025 | News

Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 25-HFD-45-01-01 Product: Drugs Recipient: Americo F. Padilla, M.D. 8955 Southwest 87th Court, Suite 110Miami, FL 33176-2264United States Issuing Office: Center for Drug Evaluation and Research...

Gepotidacin – Oral Products

by | Mar 26, 2025 | News

 Minimum Inhibitory Concentrations(mcg/mL)Disk Diffusion(zone diameter in mm)PathogenSIRSIREnterobacteralesa≤ 1632≥ 64≥ 128-11≤ 7Staphylococcus saprophyticus≤0.25–≥ 23–Enterococcus faecalis≤4–≥ 14  S = susceptible; I = intermediate; R = resistanta...

Annual Study

by | Mar 26, 2025 | News

Sign up for Compounding and Compounding Quality Center of Excellence EmailsThe FDA Compounding Quality Center of Excellence conducts the Compounding Outsourcing Facilities Annual Study to better understand industry perspectives and challenges, as well as dynamics...