Docket Number: FDA-1993-D-0184 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The FDA published Good Guidance Practices in February 1997. This guidance was […]

Issued by: Guidance Issuing Office Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice FDA Guideline […]

For Immediate Release: January 30, 2025 Today, the U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat […]

Were there any differences in side effects of the clinical trials among sex, race, and age groups? Adverse reactions through Week 16 of the placebo-controlled trials […]

HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this […]

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]

[11-03-2011] The U.S. Food and Drug Administration (FDA) is updating the public about its ongoing safety review of Tumor Necrosis Factor (TNF) blockers and malignancy (cancer) […]

One of CDER’s priorities is to communicate important regulatory and scientific information to different audiences, including patients, health care professionals, and the general public. Effective communications […]

FDA reviewed many published research studies, including both nonclinical and clinical data. Nonclinical Studies We reviewed published nonclinical studies showing that early exposure to anesthetic drugs […]