regulation articles
Which FDA center oversees new drug review for safety and effectiveness?
What food categories does the USDA/FSIS primarily regulate, separating them from FDA oversight?
What is the key pre-market approval difference between a new drug and a supplement?
What risk level classification requires the most rigorous Premarket Approval (PMA) for medical devices?
What official daily publication houses proposed rules and notices from agencies like the FDA?
Approximately what percentage of the U.S. food supply falls under the FDA's regulatory jurisdiction?
What requirement applies to cosmetics regarding market entry, unlike prescription drugs?
What strategic focus did the Food Safety Modernization Act (FSMA) establish for food processing facilities?
Under which U.S. federal department does the Food and Drug Administration (FDA) operate?
Which act granted the FDA authority to regulate the manufacture and marketing of tobacco products?
How is the Labeled Shelf Life for a drug defined according to stability working groups?
Which category of stability criteria addresses changes in measurable characteristics like elasticity or tensile strength for medical devices?
For most food products regulated by the FDA and FSIS, dating primarily indicates quality, but what is the primary exception mandated by this distinction?
What must drug applicants submit to the FDA to support a proposed expiration date and storage conditions?
Which statistical methodology for drug shelf life estimation is often dictated by the "worst-case" batch in a stability study?
What crucial interaction is explicitly stressed in FDA guidance when establishing stability for medical devices?
What are identified as the primary enemies post-purchase for commercially sealed, shelf-stable goods managed by consumers?
What term describes the actual, but unknowable, storage time a drug product will remain fit for use and effective?
What does an expiration date printed on a medical device specifically mark regarding its shelf life?
Which universal factor dictating shelf life across drugs, devices, and food includes variables like humidity and light exposure?
What does achieving The Joint Commission (TJC) certification signal for a hospital?
Which credential demonstrates specialized knowledge in healthcare quality concepts managed by NAHQ?
How does lapses in staff Basic Life Support (BLS) certification affect a hospital's standing?
What is the contrast between organizational accreditation (TJC) and CPHQ certification?
What is the significance of AHE certification for Environmental Services professionals?
Which association manages credentials ensuring staff handle patient information according to ethical standards?
What is the overarching goal of accreditation programs offered by DNV?
What administrative oversight issue is cited regarding renewing BLS certifications every two years for 800 nurses?
What must a hospital typically demonstrate to achieve certification as a chest pain center?