Priya Sinha

Arnall Golden Gregory LLP

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Latest Posts › Life Sciences

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Open Up Your Eyes: FDA Expects Real Transparency in ClinicalTrials.gov Disclosures

Based on client inquiries and FDA actions, the Food and Drug Administration is focusing more on companies not submitting data to www.ClinicalTrials.gov. It is taking stronger action against those companies it believes are...more

5/8/2024 / Clinical Trials , Compliance , Disclosure Requirements , Food and Drug Administration (FDA) , Life Sciences , Pharmaceutical Industry , Regulatory Oversight

Welcome to the Machine: FDA Issues White Paper on AI and Medical Products

For music aficionados, many would agree that the rock band, Pink Floyd, was ahead of its time. “Welcome to the Machine,” from the 1975 album Wish You Were Here, was one of those transformative songs for one of this Bulletin’s...more

4/9/2024 / Artificial Intelligence , Compliance , Food and Drug Administration (FDA) , Health Technology , Life Sciences , Medical Devices , Pharmaceutical Industry , Regulatory Oversight , White Papers

I Can See Clearly Now: FDA Issues Final Rule on DTC Rx Ads Relating to Presentation of the Major Statement in TV and Radio Format

In 1972, Johnny Nash sang the catchy song, “I Can See Clearly Now.” A little more than 50 years later, the Food and Drug Administration’s Office of Prescription Drug Promotion issued a Final Rule relating to...more

12/1/2023 / Advertising , Food & Drug Regulations , Food and Drug Administration (FDA) , Life Sciences , Marketing , OPDP , Pharmaceutical Industry , Prescription Drugs

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