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Update: Use Of Real-World Evidence In FDA Approvals And Product Promotion - Food, Drugs, Healthcare, Life Sciences

Update: Use Of Real-World Evidence In FDA Approvals And Product Promotion - Food, Drugs, Healthcare, Life Sciences
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AGG Food & Drug Newsletter - July 2021 | Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - July 2021 | Arnall Golden Gregory LLP
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Real-World Data or Not So Accurate Data: OPDP Issues Letter to Company for Misplaced Reliance on Real-World Data | Arnall Golden Gregory LLP

Real-World Data or Not So Accurate Data: OPDP Issues Letter to Company for Misplaced Reliance on Real-World Data | Arnall Golden Gregory LLP
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A Drug Company Finds Itself with a Headache and Over Its Head With Unlawful Promotional Messaging | Arnall Golden Gregory LLP

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In keeping with family tradition, another Kardashian made headlines again in our food and drug world for the wrong reasons. And FDA’s Office of Prescription Drug Promotion (OPDP) was not likely amused to issue its third letter in 2021 – its first Untitled Letter this year for unlawful promotion.
1 In this case, OPDP took exception to a direct-to-consumer video of an interview with Khloe Kardashian, a paid spokesperson for a pharmaceutical company that marketed a prescription drug product for acute treatment of migraine with or without aura in adults. The video originally appeared on the television show, ....

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Déjà Vu, We Have All Been Here Before: OPDP Issues Its Second Warning Letter in 2021 | Arnall Golden Gregory LLP

Déjà Vu, We Have All Been Here Before: OPDP Issues Its Second Warning Letter in 2021 | Arnall Golden Gregory LLP
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