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The Most Engaging Decision You’ll Read All Year – Five Stars

FDA Law

Koblitz — You know a court decision is going to be worth reading when the judges compare FDA’s regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting. FDA extended PMTA compliance deadlines for years so it could figure out appropriate application instructions and so that manufacturers could figure out how to comply.

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Would I FIE to You? FDA’s First Interchangeable Exclusivity Determination Results in Expiration

FDA Law

Important to note here is that each interchangeable biosimilar was first approved as a biosimilar and each biosimilar manufacturer had been sued under the so-called “patent dance” procedure prior to seeking licensure of the biosimilar products as interchangeable. This all sounds complicated, I know.

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Arsenicum album for Kerala school students: a bogus prophylaxis

Tiny Physician

The Kerala government has taken off all the restrictions imposed due to the case surge as caseload has come down, and is also planning to restart schools from the second half of November. However, there is no clinical trial on its effect on COVID 19 infection or its complications. To send a DM, use Telegram. References 1.