Fdc tuyển dụng 2023
•Result of 15 years of intense lobbying efforts Show Nội dung chính
•Streamlining of generic drug approval process •Applies equally to U.S. drugs and imports Upgrade to remove ads Only SGD 41.99/year
Terms in this set (43)Pure Food and Drug Act of 1906 -Required drugs to be safe, but no pre-approval process Sherley Amendment (1912) A drug is misbranded if the drug makes false therapeutic claims Purpose of FD&C Limit interstate commerce to drugs proven safe and effective; prevents adulteration and misbranding of products Elixir Sufanilamide Disaster of 1937 Antifreeze (diethylene glycol) was used in a medication and it killed many people - considered misbranding because it did not meet definition of an elixir Could not be removed due to safety issues because FDA did not hold this power at the time - only removed due to the elixir misbranding Proved that the Pure Food and Drug Act of 1906 did not work --> FD&C of 1938 creation Requirements of FD&C -FDA had to declare drugs safe before marketing Durham-Humphrey Amendment of 1951 -Established category of RX and OTC drugs and labeling requirements (legend drugs) Legend drugs RX drugs; must contain on the label Caution: Federal law prohibits dispensing without a prescription Thalidomide Disaster of 1961 Taken by pregnant women for N/V in Europe, but was actually causing birth defects This led to the FDA withholding approval in the USA - FD&C did its job Kefauver-Harris Amendment of 1962 -New drugs must be proven safe AND effective before marketing -Requires informed consent and adverse effect reporting in clinical trials Drug Efficacy Study Implementation (DESI) Established by the FDA to review all products between 1938 and 1962 and determine if they are effective, since they were already proven safe Conducted by National Academy of Sciences/National Research Council New England Compounding Center Had a recall because fungus inside of a steroid spinal injection was causing meningitis Drug Quality and Security Act of 2013 (DQSA) Created outsourcing facilities that must register with the FDA and comply with good manufacturing practices; do not have to be a pharmacy Official compendium the United States Pharmacopeia and the National Formulary (USP/NF); official listing of recognized drugs in the US; and Homeopathic Pharmacopoeia of the United States; official compendia for homeopathic products in the US Plus any supplements to these Food Articles used for food or drink for human or animals, gum, and components of these articles Food additive Directly or indirectly affects the characteristic of the food - all must be approved EX: Packaging is indirect, preservative is direct Drug 1) Recognized in the USP/NF/HUSP Structure function claim example St Johns Wort impacts levels of serotonin in the brain (does not outright say depression) New drug Drugs that have not gone through the FDA process yet to be proven safe and effective - once it is approved its no longer considered new Counterfeit drug Drug bears the trademark of a manufacturer that did not actually manufacture it Device Apparatus that is recognized by the USP/NF or intended to diagnosis/treat/prevent disease or affects structure-function of the body AND does not complete its purpose through chemical action within the body or metabolism Cosmetic Applied to the human body for altering appearance and any components of this article; does not include soap Label vs labeling Label - Anything directly on the container Tobacco Any product derived from tobacco for human consumption Dietary supplement Product intended to supplement the diet containing... Not considered a food, drug, or food additive; it has its own category --> NOT OTC DRUGS EX: St. John's Wort, Ginseng, Gingko, Saw Palmetto Dietary Supplement Health and Education Act of 1994 (DSHEA) Allows non-drug structure function claims Major claim types Structure-function: Must be truthful and does not need premarket approval Health claim: Must have relationship between substance and disease; needs premarket approval Drug claim: Subject to drug regulations; must cure, treat, prevent, or diagnosis Labeling exclusions If the information is reprinted in entirety and used in connection with sales; must be physically separated from the product and cannot say treatment on the cover page EX: Brochure Adulteration & Misbranding FDA has burden of proof, but courts cannot defer to them; instead company has to prove it is not misbranded or adulterated Considered this if it has harmful substance in it or has risk of illness under conditions of use on the label OTC drugs Must also be proven safe and effective Federal Trade Commission (FTC) Regulates advertising of OTC drugs Orphan Drug Act Incentives for manufacturers to make drugs for these diseases by giving 7 yrs of market exclusivity Prescription Drug Marketing Act Requirements for drug samples, prevents reselling drugs from hospitals, regulates wholesalers, and bans reimporting American made drugs except by the manufacturer PDUFA and GDUFA PDUFA --> Manufacturers pay fees for NDAs Prescription drug user fee amendment United States vs Johnson Showed weakness of Pure Food and Drug Act of 1906 Misbranding did not prevent false claims - only in relation to drug strength, quality, and purity - which led to manufacturers omitting label information out of fear of violation Amendment in 1912 prevented false claims, but was difficult to prove fraudulent intent and enforce the amendment Food Additives Amendment of 1958 Components of food must have premarket safety approval and contains the Delaney Clause which says that no additive can be linked to cancer Color Additive Amendments of 1960 Safety of color additives must be established premarket and cannot cause cancer; a color can be approved for one use but not others Drug Price Competition and Patent Term Restoration Act of 1984 Waxman-Hatch Amendment Gives patent extensions to innovative drugs and streamlines generic approval Food and Drug Administration Modernization Act of 1997 Requires FDA to define scope of responsibility in a mission statement and publish compliance plans after consulting with healthcare professionals and industry representatives Creates fast track approvals for life saving drugs/medical devices and creates a data bank of clinical trial information Expands authority on OTC drugs and ingredient labeling requirements How does the FDA work? Component of the Department of Health and Human Services, in which the commissioner is appointed by the President and Senate Divided into five offices Receives advice from outside experts on advisory committees Medical food A food to be taken under the supervision of a physician and intended for the dietary management of a disease/condition for which distinctive nutritional requirements are established by scientific evaluation Not considered a drug nor is special dietary foods Ephedra Dietary supplement removed from the market due to its lack of safety Supplement and Nonprescription Drug Consumer Protection Act of 2006 Requires supplement manufacturers to warn of adverse events DHSEA criticisms Makes it hard to remove unsafe supplements off of the market and prevents FDA from evaluating unsafe products premarket FDA requires supplements to undergo good manufacturing practices, but cannot inspect products prior to marketing Sets with similar termsLaw Lecture 253 terms Kayla_Creel Pharmacy Law69 terms carrie4022 Pharm Ch 141 terms Deborah_Huber4 Combo with "PA 103 Law and Ethics Week #3" and 5 o…93 terms drvlh2016 Sets found in the same folderState Licensing & Regulation33 terms Sydkyd515 Pharmacy Technician Midterm221 terms kelly_wells PTU -- Pharmacy Technician Roles, Package Inserts,…99 terms ALTAMT module 2: laws, regulations, and controlled substa…16 terms Lisa_Tunnell5TEACHER Other sets by this creatorLaw Review Packet229 terms Sydkyd515 Calculations97 terms Sydkyd515 Scope of Practice11 terms Sydkyd515 Maryland Controlled Substances26 terms Sydkyd515 Other Quizlet setsImmunology 1-105 terms mgl67 Geo Final Study Guide33 terms phillygildea Abdomen - Case Based Questions15 terms stephanie_mallia Econ Test 135 terms waaa76 What was the purpose of the Food Drug and Cosmetic FDC Act of 1938 quizlet?The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. What does the Food Drug and Cosmetic Act do for consumers quizlet?The Pure Food and Drug Act of 1906 prohibited the sale of misbranded or adulterated food and drugs in interstate commerce and laid a foundation for the nation's first consumer protection agency, the Food and Drug Administration (FDA). What is the Food Drug and Cosmetic Act of 1938?FDR signed the Food, Drug, and Cosmetic Act on 25 June 1938. The new law brought cosmetics and medical devices under control, and it required that drugs be labeled with adequate directions for safe use. What is the purpose of the Federal Food Drug and Cosmetic Act?The enactment of the 1938 Food, Drug, and Cosmetic Act tightened controls over drugs and food, included new consumer protection against unlawful cosmetics and medical devices, and enhanced the government's ability to enforce the law. |