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Orthokeratology lens. Orthokeratology, also referred to as Night lenses, Ortho-K, OK, Overnight Vision Correction, Corneal Refractive Therapy (CRT), Accelerated Orthokeretology, Cornea Corrective Contacts, Eccentricity Zero Molding, and Gentle Vision Shaping System (GVSS), is the use of gas-permeable contact lenses that temporarily reshape the cornea to reduce refractive errors such as myopia ...
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680.
An approved drug is a medicinal preparation that has been validated for a therapeutic use by a ruling authority of a government. [1] This process is usually specific by country, unless specified otherwise.
The PDUFA date serves as a good first approximation of when a final decision on drug approval can be expected. Sponsors frequently publish PDUFA dates for their pending applications, [1] and while there is no official list of PDUFA dates, [10] several websites collect PDUFA dates from press announcements in a calendar form.
The FDA may either approve the application or issue a Complete Response Letter. [2] Grounds behind issuing a CRL may include labeling issues, current Good Manufacturing Practice concerns or concerns about the safety or effectiveness of the drug. [3] A sponsor receiving CRL may withdraw the application, request a hearing or resubmit the ...
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In most countries, a marketing authorisation is valid for a period of 5 years. After this period, one should apply for renewal of the marketing authorisation, usually by providing minimal data proving that quality, efficacy and safety characteristics are maintained and the risk-benefit ratio of the medicinal product is still favourable.