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64 Cards in this Set
- Front
- Back
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WHO ART
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Adverse Reaction Terms, developed by WHO, used to code AEs to standard preferred terms and body systems; will be replaced by MedDRA
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Well Characterized
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Well defined biologics that formerly were the only ones filed with a BLA
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Warning letter
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most serious FDA post-audit letter requires immediate action within 15 days
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VAI
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Voluntary Action Indicated: moderately serious FDA post inspection classification, indicated on FDA form 483
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USP
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US Pharmacopeia: nongovernmental, not for profit, setting standards for drugs and dietary supplements. USPs documentary standards and reference standards are used by regulatory agencies and manufacturers of pharmaceuticals, OTC drugs, dietary supplements and food ingredients to ensure that these products are of the appropriate strength, quality and purity
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User Fees
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fees used by the FDA to expedite review time. the fee schedule for different application types is published annually in the federal register. initially established by the prescription drug user fee act of 1992
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unexpected AE
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an adverse event whose nature or severity is not described in the investigators brochure or in the package insert
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treatment IND
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allows limited use of an unapproved drug for patients with a serious or life threatening disease
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surrogate endpoint
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a laboratory or physical sign that is used in trials as a substitute for a clinically meaningful endpoint that is a direct measure of how a patient feels functions or survives and is expected to predict the effect of the therapy
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supplement (sPMA)
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PMA submission for changes to an approved PMA that affect the devices safety or effectiveness
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supplement (sNDA)
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NDA submission for changes to an approved NDA, including SUPAC
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SUPAC
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Scale up and post approval changes: SUPAC is a way for companies to change their manufacturing after marketing. they could need less or more manufacturing than they needed during the clinical trials. the companies should maintain all of the quality that the drug had when approved while changing different aspects of manufacturing
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substantial equivalence
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comparison of a new device to a legally marketed predicate device; substantial equivalence establishes safety and effectiveness
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subpart H
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21 CFR 314.500; approval based upon a surrogate endpoint or a product approved with restrictions and/or requirements for phase IV trials
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subpart E
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21 CFR 312; accelerated review for life threatening and severely debilitating illness
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subject
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clinical trial participant; may be a healthy volunteer or a patient
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standard review
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FDA review category for drugs with therapeutic qualities similar to those already approved for marketing
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SRD
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Single rising dose: a study design typically used in phase 1 studies to assess the safety and tolerability of a study drug. the first dose will be given to a cohort of patients and if that is well tolerated a higher single dose will be given to another cohort. if that is received well, it will again be increased until a maximum tolerated dose is found
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SR
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significant risk: usually referring to whether or not a device is more than minimal risk or just minimal risk. depending on how it is classified, depends on how much IRB review will be necessary and how much investigation of the device will be necessary
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sponsor
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company, person, organization or institution taking responsibility for initiating, managing, or financing a clinical trial
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SPL
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Structured product label: content of package insert in XML format
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source documents
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original documents and records containing information captured in a clinical study. case report forms are monitored against source documents. includes office charts, lab results, xrays, etc
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SNDA
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Supplemental New Drug Application: Supplemental NDA is new addition of information that can be used to file a new indication most commonly with a drug, could be similar to 505 b2
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significant risk device
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An investigational device that:
o Is intended as an implant o Is represented to be for use in supporting or sustaining human life o Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease or otherwise preventing impairment of human health and o Presents a potential for serious risk to the subject’s health, safety or welfare |
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SE
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Substantially equivalent:
a. Can often go hand in hand with a 510k submission where the device has to be substantially equivalent to an already marketed device b. Can also be used when talking about non-inferiority or equivalence trials, if the data falls into the Confidence interval can be described as substantially equivalent |
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SBA
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Summary Bias of Approval: now called a “review”; Now called approval packages, they are a government documents that are a distillation of the approval process, these are made available to the public
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RTF
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refusal to file
Letter sent by FDA when incomplete NDA or ANDA is filed. FDA will not review the application until complete. Letter is sent within 60 days of submission. |
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RLD
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reference listed drug
Drug product listed in the Approved Drug Products with Therapeutic equivalence Evolutions book (also known as the Orange Book). |
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RFD
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company submission to FDA to obtain a formal agency determination on which center with which to work in developing a new product. A company may submit an RFD for a combination product or for a drug, device or biological product when the jurisdiction is unclear or in dispute
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REMS
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risk evaluation and mitigation strategy
A strategy to manage a known or potential serious risk with a drug or biologic. May be required by the FDA. Strategies can include package inserts, medication guides, various communication plans, and other elements to help ensure the drug’s safe use. |
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Records for investigators
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o Correspondence
o Investigational Drug receipt, use, disposition o Case Histories Informed Consent Source documentation (case report forms and medical records) Safety reports Protocol and other records Laboratory information |
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sponsor records
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o Correspondence
o Investigational drug shipment and disposition o Investigator agreements and financial disclosure o Clinical study report and publications o Monitoring and safety reports (serious adverse events) o Investigator list o IRB list and other records o Decoding and randomization records (if applicable) |
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investigator reports (21 CFR 312.64)
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o Progress reports (to sponsor and IRB; at least annually)
o Safety reports o Financial report o Financial disclosure reports |
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sponsor reports (21 CFR 312.31) form 1571
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o IND Amendments
Amendments to an IND, any new developments or changes Investigator or new information must be submitted within 30 days of signature date. o IND Safety Reports (21 CFR 312.32, Form 1571, 3500 A) Telephone report • Unexpected fatal or life-threatening adverse effect (AE) associated with the use of the drug and seven calendar days (either by phone or fax) Written reports • Serious and unexpected AE associated with the use of the drug • Other serious AEs, 15 calendar days o IND Annual Reports (21 CFR 312.33, Form 1571) Must be submitted within 60 days of the anniversary date of when the IND became effective. |
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record (21 CFR 312.57)
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o Sponsor: 2 years after NDA approval or development of drug is discontinued
o Investigator: same as sponsor |
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QSR
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Quality System Regulations (21 CFR 820): applies GMPs to medical devices
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PTC
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points to consider: type of guidance published by FDA, usually by CBER
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protocol
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document describing a clinical trial's objectives, design and methods. All GLP and GCP studies must follow a protocol
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promotion and advertising (Rx Drug Advertising)
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Regulated by DDMAC, Division of Drug marketing, Advertising and communications
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preclinical studies
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Animal studies of pharmacokinetics (PK) and toxicity generally performed prior to clinical studies. These studies mush comply with Good Laboratory Practices (GLPs).
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PMS
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post marketing surveillance
Ongoing monitoring of the safety of approved drugs; may include Phase IV studies and AE reporting. |
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PMN
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Premarket Notification
A premarket notification is also called a required 510(k) for nonexempt Class I and Class II devices |
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PMA
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Premarket Approval
Marketing application required for class 3 devices |
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PK
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Pharmacokinetics:
The study of the processes of absorption, distribution, metabolism, and excretion (ADME) of chemicals and medicines |
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PI
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principal investigator
runs the clinical trial at the site level, is responsible for patient safety and a well run trial |
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package insert
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all info from NDA condensed into one piece of paper to give prescriber and pharmacist info about the drug
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PHC
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Public Health Committee
a committee designated to tend to matters of a particular state, where health for the citizens are concerned. The description below pertains to the Connecticut general assembly, but typically, each state has a public health committee that is designated to tend to health matters of its citizens. (See description below for example of specific duties): “The Public Health Committee is one of the joint standing committees of the Connecticut General Assembly. It has cognizance of all programs and matters relating to the Department of Public Health; the Department of Mental Health and Addiction Services and the Department of Developmental Services; the Office of Health Care Access; and all other matters relating to health, including emergency medical services, all licensing boards within the Department of Public Health, nursing homes, pure food and drugs, and controlled substances, including the treatment of substance abuse.” |
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phase 2
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Well-controlled clinical trials of approximately 100-300 subjects who have ht condition of interest, includes PK, dose ranging, safety and efficacy.
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phase 3
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Larger, well-controlled clinical trials of hundreds to thousands of subjects, including both safety and efficacy data. Generally, two well-controlled studies are needed to establish efficacy.
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pharmacovigilance
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adverse event monitoring and reporting
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PDUFA
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Prescription Drug User Fee Act of 1992: Passed to accelerate and improve the quality of FDA’s drug and biologic application reviews. PDUFA required drug and biologics manufacturers to pay fees for their applications and supplements. NOTE: Generics, cosmetics, and OTC drugs are exempted from these fees. So too are medical devices except medical devices to pay fees under MDUFMA.
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PDMA
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Prescription Drug Marketing Act: Prescription Drug Marketing Act. Passed in 1988, PDAMA was enacted to address certain prescription drug marketing practices that diverted large quantities from the primary market, including distribution of free samples, the use of coupons redeemable for drugs at no cost or low cost, and the sale of deeply discounted drugs to hospitals and healthcare entities.
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PD
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Pharmacodynamics: Study of the reactions between drugs and living structures.
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OSHA
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Occupational Safety Health Administration: OSHA is part of the US Dept of Labor and is the main federal agency responsible for the enforcement of safety and health legislation. Its mission is to prevent work-related injuries, illnesses, and deaths by the rules it enforces.
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Orange Book
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FDA-published listing of Approved Drug Products with Therapeutic Equivalence Evaluations generally known as generics (has an orange cover).
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OGD
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Office of Generic Drug Products (FDA): Is part of the Office of Pharmaceutical Sciences within the Center for Drug Evaluation and Research (CDER). Abbreviated New Drug Applications are reviewed by FDA’s Office of Generic Drugs.
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OAI
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Official Action Indication: serious FDA post inspection classification, indicated on FDA form 483
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NSE
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Not Substantially Equivalent: Designation for device that does not qualify for 510(k) clearance; may require a PMA.
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NLM
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National Library of Medicine: The NLM is on the campus of the National Institutes of Health in Bethesda, MD, and is the world’s largest medical library. The Library collects materials and provides information and research services in all areas of biomedicine and health care.
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NIH
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National Institutes of Health: The NIH is part of the U.S. Dept. of Health and Human Services and serves as the primary Federal agency for conducting and supporting medical research.
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NF
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National Formulary (incorporated into the USP-NF): The NF is published with the US Pharmacopeia and includes standards for excipients, botanicals, and other similar products.
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NDC
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National Drug Code: The first five digits identify establishment and last five digits identify drug name, package size and drug type. Identifies the labeler/vendor, product and trade package size. The first segment (5 digits), the labeler code, is assigned by FDA. The second segment, the product code, identifies a specific strength, dosage form and formulation for a particular firm. The third segment (last 5 digits), the package code, identifies the package size.
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NDA Field Alert
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Report filed with FDA within three working days of obtaining information on any distributed drug product that has contamination, significant chemical or physical change, deterioration, batch failure or labeling causing mistaken identity.
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NCCLS
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National Committee for Clinical Laboratory Standards-Follows GLP, used to accurately and reliably reproduce results with an emphasis on microbial contamination of medicinal products, most of the world tries to use these standards as well
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