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June 3, 2022

Generic Drugs – Specific Labeling Resources

Who Is the Audience for This Website? FDA’s generic drug-specific labeling resources are primarily directed to industry staff who develop generic drug labeling. For more information […]
June 3, 2022

Selection of Appropriate SPL Codes for Human Prescription Drug Labeling

This supplementary webpage is primarily directed to Structured Product Labeling (SPL) developers to assist in selection of appropriate SPL codes for human prescription drug* labeling.  See […]
June 3, 2022

Carton and Container Labeling Resources

On this webpage Who Is the Audience for This Website? FDA’s carton and container labeling specific resources on this webpage are primarily directed to industry staff […]
June 3, 2022

Patient Labeling Resources

On this page Who is the audience for this webpage? FDA’s patient labeling specific resources on this webpage are primarily directed to industry staff who develop […]
June 3, 2022

Prescribing Information Resources

Who is the Audience for This Webpage? FDA’s Prescribing Information (PI) resources on this webpage are primarily directed to industry staff who develop PI. For other […]
June 3, 2022

FDA’s Labeling Resources for Human Prescription Drugs

FDA’s labeling resources for human prescription drugs are primarily directed to industry staff who develop human prescription drug* labeling. Human prescription drug labeling (1) contains a […]
June 3, 2022

ACL Repair: Long-Term Improvement Worse in Females ACL Repair: Long-Term Improvement Worse in Females

Elizabeth S. Bjornsen Males who underwent anterior cruciate ligament reconstruction (ACLR) improved more quickly than females who underwent the same procedure, according to a study based […]
June 3, 2022

High-Dose Antipsychotics Effective in Refractory Schizophrenia High-Dose Antipsychotics Effective in Refractory Schizophrenia

NEW ORLEANS – Patients with severe schizophrenia who fail to respond to treatment with standard doses of second-generation antipsychotics show significant improvement with – and tolerance […]
June 3, 2022

Novavax Hopes Its COVID Shot Wins Over FDA, Vaccine Holdouts Novavax Hopes Its COVID Shot Wins Over FDA, Vaccine Holdouts

GAITHERSBURG, Md. (AP) — Americans may soon get a new COVID-19 vaccine option — shots made with a more tried-and-true technology than today’s versions. The big […]
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