Laura Dona

Arnall Golden Gregory LLP

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Latest Posts › Clinical Trials

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I’m Looking Through You/You Won’t See Me: FDA Issues Guidance Document Concerning Presentation of Certain Information in DTC...

“I’m Looking Through You” and “You Won’t See Me,” both songs from The Beatles’ 1965 Rubber Soul album, came to mind when we read the Food and Drug Administration’s recently issued document, “Presenting Quantitative Efficacy...more

7/6/2023 / Advertising , Clinical Trials , Direct to Consumer Sales , Food and Drug Administration (FDA) , Life Sciences , Marketing , Pharmaceutical Industry , Prescription Drugs , Risk Assessment

And I Won’t Tell No One Your Name: Doesn’t Matter, FDA Reminds IVD Industry of IRB Review in Certain Cases

The authors doubt the Food and Drug Administration was humming the Goo Goo Dolls 1995 hit, “Name,” when it drafted its letter, dated October 18, 2021, to manufacturers of in vitro diagnostics to remind them that the agency...more

10/29/2021 / Biologics , Clinical Trials , Food and Drug Administration (FDA) , IRB , Medical Research

AGG Food & Drug Newsletter - October 2021

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

10/28/2021 / Clinical Trials , Cyber Attacks , Department of Justice (DOJ) , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Inspections , Insurance Industry , Manufacturers , Pharmaceutical Industry

Recruitment Incentives in Clinical Trials

Recruiting a sufficient number of trial participants is a common difficulty for clinical trial sponsors. To obtain such numbers, sponsors may offer financial incentives to investigators or study sites or site personnel to...more

10/27/2021 / Clinical Trials , Food and Drug Administration (FDA) , Pharmaceutical Industry , PHRMA , Recruitment Incentives

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