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  2. Orthokeratology - Wikipedia

    en.wikipedia.org/wiki/Orthokeratology

    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 ...

  3. Food and Drug Administration Safety and Innovation Act

    en.wikipedia.org/wiki/Food_and_Drug...

    The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.

  4. Accelerated approval (FDA) - Wikipedia

    en.wikipedia.org/wiki/Accelerated_approval_(FDA)

    Drugs approved under the FDA Accelerated Approval Program still need to be tested in clinical trials using endpoints that demonstrate clinical benefit, and those trials are known as phase 4 confirmatory trials. If the drug later proves unable to demonstrate clinical benefit to patients, the FDA may withdraw approval.

  5. Does This FDA Approval Mean Anything? - AOL

    www.aol.com/2012/10/12/perrigo

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  6. Just in time for back to school: This FDA-registered KN95 ...

    www.aol.com/lifestyle/just-time-back-school-fda...

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  7. Biologics license application - Wikipedia

    en.wikipedia.org/wiki/Biologics_License_Application

    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.

  8. US FDA approves Dupixent to treat younger kids with ... - AOL

    www.aol.com/news/us-fda-approves-dupixent-treat...

    The U.S. Food and Drug Administration (FDA) in 2022 approved the blockbuster anti-inflammatory drug for treating eosinophilic esophagitis (EoE) in patients aged 12 years and older, making it the ...

  9. Approved Drug Products with Therapeutic Equivalence ...

    en.wikipedia.org/wiki/Approved_Drug_Products...

    The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons. Inclusion of products on the List is independent of any current regulatory action through administrative or judicial means against a drug product.