law exam 1.pdf

Who administers the food drug and cosmetic act (FDCA)? - FDA The FDA is a component of the _________. - Department of health and human services (DHHS) The pure food and drug act of 1906 is aka ______. - Wiley- Heyburn Act The pure food and drug act of 1906 prohibited _______ and _________ of food an...

Who administers the food drug and cosmetic act (FDCA)? - FDA The FDA is a component of the _________. - Department of health and human services (DHHS) The pure food and drug act of 1906 is aka ______. - Wiley- Heyburn Act The pure food and drug act of 1906 prohibited _______ and _________ of food and drugs in interstate commerce. - Adulteration and misbranding ________ was prompted by public concern over unsanitary practice in the food and drug industries. - Pure food and drug act of 1906 The Food, Drug, and Cosmetic Act of 1938 (FDCA) was prompted by the _______. Sulfanilamide tragedy The ________ stated that no new drug could be marketed until proven safe for use. Food, Drug, Cosmetic Act of 1938 ________ established 2 classes of drugs (OTC vs. PrescriptioN). - Durham- humphrey amendment of 1951 Which act was prompted by the thalidomide disaster? - Kefauver-harris amendment of 1962 _________ strengthened the new drug approval process by requiring that drugs be proven safe AND effective. - Kefauver-harris amendment of 1962 what qualifies a drug as an orphan drug? - rare diseases/conditions= fewer than 200,000 Americans The drug price competition and patent term restoration act of 1984 is aka the _______. Waxman- Hatch Amendment of 1984 _________ allowed companies to submit an ANDA for approval of generic products. Drug price competition and patent term restoration act of 1984 (Waxman- hatch amendment) __________ are available only if the patent has not expired. - Patent- term extensions _______ works independently of a drug's patent status. - Market exclusivity ________ was created for innovator manufacturers and established patent- term extensions or market exclusivity for 2- 5 years, depending on when the regulatory review of the drug began and how much time it required. - Drug Price Competition and patent term restoration act of 1984 what are the most significant provisions to the Food and Drug Administration Modernization Act of 1997? - - pharmacy compounding - expediting study and approval of fast track drugs - elimination of certain labeling requirements - dissemination of off label treatment info - encouragement of pediatric studies which act created the elimination of certain labeling requirements, including changing "caution: Federal law prohibits dispensing without a prescription" to "RX only?" - Food and Drug Administration Modernization Act of 1997 (FDAMA) A drug is defined as articles intended for use in the _____________________________ of disease in man or other animals. - diagnosis, cure, mitigation, treatment, or prevention ________ is a drug that is "not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use." - New drug what are the 2 purposes of the IND? - 1. protect the safety of the humans who will participate in the clinical trials 2. Ensure that the clinical studies are designed properly so as to prevent problems during the NDA review If the FDA does not reject the IND request within __________, _________ may begin. - 30 days of submission - human clinical testing Describe the subject of phase 1 clinical trials - small number of healthy individuals Describe the purpose of phase 1 clinical trials - evaluate toxicology, PK, pharmacology, and also to determine safety Who are phase 1 clinical trials conducted by? - the sponsoring company (drug company) Describe the subject composition of phase 2 clinical trials - 100 or more pts who have the disease that the drug is intended to treat What is the purpose of phase 2 clinical trials? - - determine effectiveness of drug and to obtain info about adequate dosage, relative safety, and AE's Who are phase 2 clinical trials conducted by? - sponsoring company Describe the subject composition of phase 3 clinical trials - hundreds or thousands or pts (often occur in clinical settings such as hospitals/doctors offices) What is the purpose of phase 3 clinical trials? - to obtain data concerning the drugs effectiveness as compared to a control group that receives a placebo (most are double blinded) Who are phase 3 clinical trials conducted by? - independent investigators at remote and varied clinical sites (NOT THE DRUG COMPANY) In ALL 3 phases of clinical trials, the FDCA requires the investigators to secure _________ of the patients for the administration of an experimental drug. - informed consent True/False Only about 1 in 10 drugs demonstrate enough merit to submit an NDA. - True Under the provision of postmarking surveillance, the manufacturer must submit to the FDA what 5 things? - 1. reports of serious AE's 2. new info related to the drugs safety and efficacy 3. info about current clinical studies 4. quantity of drug distributed 5. info about labeling and advertising How does the FDA monitor drugs after they have been approved? - post marketing surveillance _______ granted the FDA the authority to require phase 4 testing for any prescription drug. - FDAAA FDAMA modified the FDCA to state that an investigational new drug may be provided for _________ outside controlled clinical trials to treat patients with serious or immediately life-threatening diseases for which no comparable or satisfactory therapy is available Widespread access Under what circumstances can an individual patient acting through a physician may request an investigational drug from the manufacturer? - 1. The physician determines that the patient has no comparable or satisfactory alternative therapy and that the risk to the patient from the drug is no greater than the risk from the disease or condition. 2. FDA determines enough evidence of safety/efficacy to support use, and the use of drug will not interfere with clinical investigations in support of marketing approval. 3. The sponsor (manufacturer) submits to the FDA a protocol describing the use of the drug ______ creates an alternative pathway to investigational drugs by removing the FDA from the process, allowing the patient to go straight to the manufacturer. - Right- to- try Which amendment allowed for right- to- try laws? - amendment to FDCA in may of 2018 An emergency use authorization (EUA) is a mechanism to facilitate the availability and use of ________,________, during public health emergencies, such as the current covid-19 pandemic. - medical countermeasures, including vaccines a _______ does NOT constitute the approval of the drug in full statutory meaning of the term, but instead authorizes the FDA to facilitate availability of an unapproved product. Emergency Use Authorizations (EUA's) From a safety perspective, what expectations does the FDA have of the manufacturers, following EUA's? - - EUA submission includes all data from phase 1 and 2 trials - phase 3 data will include a median follow up of at least 2 months after completion of full regimen What are 2 things that an Abbreviated New Drug Application must demonstrate? - 1. bioequivalance 2. acceptable manufacturing methods and controls what does a type 1 chemical classification of a new drug indicate? - a new molecular entity What does a type 6 chemical classification of a new drug indicate? - new therapeutic indication for a drug already approved _______ indicates that the drug represents a major therapeutic gain because there are no other effective drugs available for treating a particular illness or because it has significant advantages compared to currently marketed drugs. - Type P (Priority) ______ drugs are given priority review. - Type P (Priority) ________ indicates that the drug is similar to other drugs on the market. - Type S (Standard) ______ drugs get standard review. - Type S (Standard) What are the 2 types of therapeutic classification? - - Type P (Priority) - Type S (Standard) Nonprescription drug product advertising is regulated by the ________. - Federal trade commission (FTC) True/False There are no federal regulations that address direct- to- consumer prescription drug advertising. - True ______ is a numbering system that aids in identifying a drug product. - National drug code (NDC) NDC is required for _______ drugs. - Prescription and OTC True/False There is a federal law requiring that NDC numbers must appear on individual dosage units and on prescription labels. - False (there is NO federal law requiring that) Describe the first section (first 5 digits) of the NDC number - manufacturer code: identify the manufacturer, packager, or distributer Describe the second section of the NDC number - product code: identifies the strength, dosage form, and formulation Describe the third section of the NDC number - Package code: identifies the package size and type The FDA requires that manufacturers _________ solid dosage forms, whether they are rx or nonrx products. - imprint What does the imprint code on solid dosage forms indicate? - manufacturer and specific drug product Manufacturers must be registered with the FDA and are normally inspected by the FDA for compliance with CGMP how often? - once every 2 years ________ are a set of regulations that establishes minimum requirements for the methods, facilities, or controls used in the manufacture, processing, packaging, or holding of a drug product. - Current Good Manufacturing practices (CGMP) ______ refers to the composition of a drug. - Adulteration ______ refers to the labeling of a drug. - Misbranding