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A safety data sheet ( SDS ), [ 1] material safety data sheet ( MSDS ), or product safety data sheet ( PSDS) is a document that lists information relating to occupational safety and health for the use of various substances and products. SDSs are a widely used type of fact sheet used to catalogue information on chemical species including chemical ...
Form FDA 483. The U.S. Food and Drug Administration (FDA) is authorized to perform inspections under the Federal Food, Drug, and Cosmetic Act, Sec. 704 (21 USC §374) "Factory Inspection". [ 1] Form FDA 483, [ 2] "Inspectional Observations", is a form used by the FDA to document and communicate concerns discovered during these inspections.
The FDA Adverse Event Reporting System ( FAERS or AERS) is a computerized information database designed to support the U.S. Food and Drug Administration 's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses FAERS to monitor for new adverse events and medication errors that might ...
Description. Drug Master File (DMF) is a document containing complete information on an Active Pharmaceutical Ingredient (API) or finished drug dosage form. It is known as European Drug Master File (EDMF) or Active Substance Master File (ASMF) and US-Drug Master file (US-DMF) in Europe and United States respectively.
Risk Evaluation and Mitigation Strategies ( REMS) is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects. REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. [ 1] The REMS program was formalized in 2007.
The Unique Device Identification (UDI) System is intended to assign a unique identifier to medical devices within the United States, Europe, China, South Korea, Saudi Arabia and Taiwan. [1] It was signed into law in the US on September 27, 2007, as part of the Food and Drug Administration Amendments Act (Section 226) of 2007 .
MedWatch is the Food and Drug Administration ’s “Safety Information and Adverse Event Reporting Program.”. It interacts with the FDA Adverse Event Reporting System (FAERS or AERS). MedWatch is used for reporting an adverse event or sentinel event. Founded in 1993, this system of voluntary reporting allows such information to be shared ...
July 26, 2024 at 11:26 AM. (Reuters) -The U.S. Food and Drug Administration on Friday warned patients and doctors about dosing errors associated with compounded versions of Novo Nordisk's weight ...