Search results
Results From The WOW.Com Content Network
The Generic Product Identifier ( GPI) is a 14-character hierarchical classification system created by Wolters Kluwer's Medi-Span that identifies drugs from their primary therapeutic use down to the unique interchangeable product regardless of manufacturer or package size. The code consists of seven subsets, each providing increasingly more ...
It also talks about the FDA citizen petition. The 1100 series includes updated rules deeming items that statutorily come under the definition of "tobacco product" to be subject to the Federal Food, Drug, and Cosmetic Act as amended by the Tobacco Control Act. The items affected include E-cigarettes, Hookah tobacco, and pipe tobacco. [5]
The National Medical Products Administration is directly under the State Council of the People's Republic of China, which is in charge of comprehensive supervision on the safety management of food, health food and cosmetics and is the competent authority of drug regulation in mainland China. [6]
Inclusion of products on the List is independent of any current regulatory action through administrative or judicial means against a drug product. In addition, the Orange Book contains therapeutic equivalence evaluations (2 character rating codes) for approved multisource prescription drug products ( generic drugs ).
A stethoscope (U.S. FDA product code BZS), a popular Class I medical device as determined by the U.S. FDA, ubiquitous in hospitals. The regulatory authorities recognize different classes of medical devices based on their potential for harm if misused, design complexity, and their use characteristics.
The Unique Ingredient Identifier ( UNII) is an alphanumeric identifier linked to a substance's molecular structure or descriptive information and is generated by the Global Substance Registration System (GSRS) of the Food and Drug Administration (FDA). It classifies substances as chemical, protein, nucleic acid, polymer, structurally diverse ...
The drug identification number (DIN) is the 8 digit number located on the label of prescription and over-the-counter drug products that have been evaluated by the Therapeutic Products Directorate (TPD) and approved for sale in Canada. [citation needed] Once a drug has been approved, the Therapeutic Products Directorate issues a DIN, which ...
Epedigree. Epedigree on a package with Levothyroxine. An epedigree (sometimes referred to as e-pedigree or electronic pedigree) is an electronic document which provides data on the history of a particular batch of a drug. It satisfies the requirement for a drug pedigree while using a convenient electronic form.