Us patent act - Study guides, Class notes & Summaries

Which of the following brand name products may not be substituted under New York's "negative formulary"? - Phenergan IR tablets, suppositories, solution for injection, oral suspension correct answers SUPPOSITORIES (along with ER formulations, they need to determine bioequivalence. Therapeutic equivalents that may be substituted must be... correct answers Bioequivalent and approved ANDA What are some enforcement tools utilized by the FDA? correct answers 1) Seizure of drugs 2) Criminal ...

Assumed Name Certificate - A domestic or foreign corporation, limited liability company, limited partnership, limited liability partnership, or other foreign filing entity that regularly conducts business or renders a professional service in this state under a name other than its legal name (the name stated in its certificate of formation. E.g) Copyright Rights - 1. Right to reproduce the work 2 Right to publish or distribute the work 3. Right to display the work in public 4. Right to per...

PTCB - Pharmacy Laws Verified Solutions Pure food and drugs act of 1906 ️prohibit the interstate transportation or sale of adulterated or misbranded food or drugs What does Adulterated mean? ️Consists of any filthy, decomposed, putrid susbtance Perpared, packed, or help under unsanitary conditions Perpared in containers composed of any poisonous or deleterious substance Containing unsafe color additives Recognized in an official compendium but differing in strength, quality, o...

US Rac Exam With 100% Questions With Correct Answers Kefauver-Harris Amendments - Answer - 1962 amendments to FD&C Act. Require drug manufacturers to prove products safe and effective prior to marketing. Gave FDA control over prescription drug advertising established GMPs and requirement of informed consent Drug Price Competition and Patent Term Restoration Act - Answer - 1984. Hatch-Waxman Act. Permitted FDA to approve ANDAs for generic drugs when patent of innovator drug expired. No anim...

hyperventilation, if someone is blowing off too much CO2 they become more Correct Answer- Alkaline, respiratory alkalosis if a patient's lung are not functioning very well and they are unable to remove or blow off CO2 very well, the CO2 will build up in their system becoming Correct Answer- acidic, respiratory acidosis Perfusion Correct Answer- is adequate arterial blood flow through the peripheral tissues (peripheral perfusion) and blood that is pumped by the heart to oxygenate major b...

Pure Food and Drug Act - Answer 1906 - Forbade the manufacture or sale of mislabeled or adulterated food or drugs, it gave the government broad powers to ensure the safety and efficacy of drugs in order to abolish the "patent" drug trade. Still in existence as the FDA. The Food Drug and Comestic Act of 1938 - Answer Established the Food and Drug Administration (FDA). Primarily regulates drug development, manufacturing, and marketing- focus on quality. Only safe and properly labeled dr...

NAPSR CNPR Exam - 14th Edition Correct answers latest update True or False? The FDA regulates the introduction of new drugs and enforces U.S. drug laws. True True or False? Pharma companies must submit extensive data to the FDA demonstrating the safety and effectiveness of new drugs before receiving approval for sale. True What is the average review time for a new drug? 18 months Sales Team (pg 7) Pg 7 What is considered the "engine of innovation," focused on dis...

Pass the Virginia MPJE Rated A+ Legislative bodies that enact laws governing pharm practice in VA assembly primary regulatory bodies US congress and va general Federal Food & Drug Administration (FDA) federal drug enforcement *administration* (DEA) and the VA BOP majority are governed by DEA and VA BOP The Pure Food and Drug Act of ____ 1906 - Forbade the manufacture or sale of *-*mislabeled* or *adulterated* food or drugs, it gave the government broad powers to ensure th...

Intellectual Property correct answers property of the mind for which property rights are recognized. patent correct answers granted by government by application to someone that came up with a new product or changes to an existing product. Has to be applied for and granted by the US government. Doctors patent a lot of techniques. Copyright correct answers cant copy right words but the order within those words are placed Trademarks correct answers some design or expression or use of color...

RAC Chapter 16N (13) - Generic Drug Submission Questions and Answers What is considered a generic drug? ANSWER The term "generic drug" is not defined in the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C Act) or in US Food and Drug Administration (FDA) regulations. It generally is used, however, to refer to a drug product with the same active ingredient, dosage form, strength and route of administration as a brand-name drug and for which FDA has concluded that the generic can be sub...