By statute, a company seeking FDA approval of a new drug must include in their new drug application (NDA) any patent that either (1) “claims the drug” and “is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent”; or (2) “claims a method of using such drug for which approval ...
How Do I use the Electronic Orange Book to find approved generic drugs? First, if you have the trade name, search the Electronic Orange Book's Rx or OTC section using the Proprietary Name search. This determines the ingredient(s). Then use the Ingredient Search for all approved products that contain the ingredient(s).
Generally, an authorization provides the authority for a doctor's release of PHI for specified purposes, which are generally other than treatment, payment, or healthcare operations, or, to disclose protected health information to a third party specified by the individual.
A release of information is a legal document that allows patients to specify what parts of their medical records they want to be made public, to whom they want those parts made public, for how long, and under what legal restrictions or rules.
Reference Standard (RS) A “reference standard” is the drug product selected by FDA that an applicant seeking approval of an ANDA must use in conducting an in vivo bioequivalence study required for approval of an ANDA. In the electronic Orange Book, a reference standard is identified by “RS” in the RS column.
“The purpose of listing a patent in the Orange Book is to put potential generic manufacturers on notice that the brand considers the patent to cover its drug.”8 The Orange Book patent list is the statutory mechanism for identifying and potentially resolving certain patent disputes while 505(b)(2) applications9 and ...
How Do I use the Electronic Orange Book to find approved generic drugs? First, if you have the trade name, search the Electronic Orange Book's Rx or OTC section using the Proprietary Name search. This determines the ingredient(s). Then use the Ingredient Search for all approved products that contain the ingredient(s).
The publication, Approved Drug Products With Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book), identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
Orange is an open-source data visualization, machine learning and data mining toolkit. It features a visual programming front-end for exploratory qualitative data analysis and interactive data visualization.
Orange can import any comma, . xlsx or tab-delimited data file or URL. Use the File widget and then, if needed, select class and meta attributes. To specify the domain and the type of the attribute, attribute names can be preceded with a label followed by a hash.