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Primary Care Providers Can Prescribe with Confidence

Information and resources are available to help primary care providers manage OUD with the help of medications for opioid use…

FDA Rationale for Recognition Decision: Voriconazole

FDA Rationale for Recognition Decision: Voriconazole

FDA Rationale for Piperacillin-Tazobactam Breakpoints for Enterobacterales

FDA Rationale for Piperacillin-Tazobactam Breakpoints for Enterobacterales

FDA Rationale for Piperacillin Tazobactam Breakpoints for Pseudomonas aeruginosa

FDA Rationale for Piperacillin Tazobactam Breakpoints for Pseudomonas aeruginosa

FDA Rationale for Recognition Decision: Daptomycin

FDA Rationale for Recognition Decision: Daptomycin

FDA Rationale for Breakpoints Recognition Decision: Polymyxins and Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter spp.

FDA Rationale for Breakpoints Recognition Decision: Polymyxins and Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter spp.

Rationale for FDA’s Position on Ceftazidime Breakpoints against Stenotrophomonas Maltophilia

Rationale for FDA’s Position on Ceftazidime Breakpoints against Stenotrophomonas Maltophilia

FDA Rationale for Recognition Decision: Ceftaroline fosamil

FDA Rationale for Recognition Decision: Ceftaroline fosamil

FDA Rationale for Recognition Decision: Cefiderocol

FDA Rationale for Recognition Decision: Cefiderocol

Setting and Implementing Standards for Narrow Therapeutic Index Drugs

CDER’s Narrow Therapeutic Index Drugs (NTI) working group works to resolve key NTI scientific and regulatory issues.