FDA has reevaluated the rationale document submitted by the Clinical and Laboratory Standards Institute (CLSI) to susceptibility test interpretive criteria (STIC) docket #FDA-2017-N-5925 entitled, “Polymyxin Breakpoints […]

Amikacin Injection FDA does not recognize M100 standard (MIC and disk diffusion) for Enterobacterales and Pseudomonas aeruginosa Antibacterial 4/21/2023 Amoxicillin and clavulanate Oral FDA does not […]

Image By: Robert M. Califf, M.D., Commissioner of Food and Drugs What we now call real-world data (RWD) have been used for years in medical product […]

On February 11, 2025, the Food and Drug Administration approved brentuximab vedotin (Adcetris, Seagen Inc., a subsidiary of Pfizer) in combination with lenalidomide and a rituximab […]

Docket Number: FDA-2017-D-6821 Issued by: Guidance Issuing Office Center for Veterinary Medicine Center for Biologics Evaluation and Research Center for Drug Evaluation and Research As part […]

On February 11, 2025, the Food and Drug Administration approved mirdametinib (Gomekli, SpringWorks Therapeutics, Inc.), a kinase inhibitor, for adult and pediatric patients 2 years of […]

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 […]

What is the RDRC Program? The Radioactive Drug Research Committee (RDRC) program began when the Food and Drug Administration published a Federal Register notice on July […]

Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 25-HFD-45-02-01 Product: Drugs Recipient: Recipient Name Jack Oswald Recipient Title CEO ISOThrive, Inc. 2165 Toyon […]