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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.
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). [1] It is divided into three chapters: Chapter I — Food and Drug Administration
In its Guidance for Industry "Data Integrity and Compliance With Drug CGMP" US-FDA states “it is the role of management with executive responsibility to create a quality culture where employees understand that data integrity is an organizational core value and employees are encouraged to identify and promptly report data integrity issues ...
The U.S. JASON task force report on "A Robust Health Data Infrastructure" says that FHIR is currently the best candidate API approach, and that such APIs should be part of stage 3 of the "meaningful use" criteria of the U.S. Health Information Technology for Economic and Clinical Health Act.
On Monday, the U.S. Food and Drug Administration (FDA) announced that, for the first time, it is setting guidelines for an acceptable level of lead in processed baby food, including canned fruit ...
But, as with all FDA guidances, it was not intended to convey the full force of law—rather, it expressed the FDA's "current thinking" on Part 11 compliance. Many within the industry, while pleased with the more limited scope defined in the guidance, complained that, in some areas, the 2003 guidance contradicted requirements in the 1997 Final ...
China currently accounts for 13% of the world's API manufacturers, according to the FDA. A worker produces diclofenac sodium injection at a pharmaceutical company in Suqian, China, on September 13 ...