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The Future Of Vision And Eye Care

The Medical Futurist

The California-based firm, Second Sight , the German company, Retina Implant AG, and the French venture, Pixium Vision were the forerunners of the field, developing implantable visual prosthetics to restore vision to patients who are blind as a result of the rare condition of retinitis pigmentosa.

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A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.

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It Takes Three [Components] to Make a Thing Go Riiiiiight – OPDP Challenges Two-Part Ad

FDA Law

Component 1 was a disease state component – identified as “The Journey Forward: Ryan Murphy” or “The Journey Forward: Allysa Seely.” (Note that Allysa Seely is a Paralympian gold medal triathlete, and swimmer Ryan Murphy is a 2016 Olympian and gold medalist.)

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Joint Basis for FDA/HHS Marijuana Rescheduling Recommendation Unveiled

FDA Law

FDA conducted the eight-factor scheduling analysis required by the CSA in 2016 and found that marijuana continued to meet the scheduling criteria for remaining in schedule I. 12, 2016); Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed. Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed.

Medical 69
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A Review of H5N1

Alabama Academy of Family Physicians

Since 2016, HPAI H5N1 has been detected in wild birds in the United States during screening efforts by wildlife authorities. Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed. H5N1 is currently known to be widespread among wild birds and is thought to be spread by migratory waterfowl.

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Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

FDA Law

We wondered how given that HHS and the Drug Enforcement Administration (“DEA”) conducted eight-factor scheduling analyses in 2016, concluding that there was “no substantial evidence that marijuana should be removed from Schedule I.” 12, 2016) ; Denial of Petition to Initiate Proceedings to reschedule Marijuana, 81 Fed. 12, 2016).

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MedTech Conference Download

FDA Law

For whose manufacturers who do not intend to continue device distribution, FDA generally does not intend to request market removal of those devices distributed before the applicable EUA termination or guidance withdrawal date. Maisel also discussed disposition of already distributed devices.

Medical 59