FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only […]

Docket Number: FDA-2018-D-0178 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance provides recommendations to sponsors on the clinical development of drugs […]

We reviewed cases from U.S. poison control center calls and published articles in the medical literature1,2 of serious ocular adverse events following accidental ocular exposure to […]

We searched the FDA Adverse Event Reporting System (FAERS) database and reviewed four epidemiological studiesa1,2,3,4 to investigate the association between fluoroquinolone antibacterial use and the risk […]

[8-29-2018] The U.S. Food and Drug Administration (FDA) is warning that cases of a rare but serious infection of the genitals and area around the genitals […]

[11-29-2018] The U.S. Food and Drug Administration (FDA) is warning that rare but serious cases of stroke and tears in the lining of arteries in the […]

en Español Drug Safety Communication (PDF – 59KB) 09-24-2020  FDA Drug Safety Communication The U.S. Food and Drug Administration (FDA) is warning that taking higher than recommended […]

The U.S. Food and Drug Administration (FDA) is warning that hepatitis C treatments Viekira Pak and Technivie can cause serious liver injury mostly in patients with […]

The Food and Drug Administration (FDA) is warning that the medicine lamotrigine (Lamictal) for seizures and bipolar disorder can cause a rare but very serious reaction […]