Laura Dona on Food & Drug Regulations

This Time of Year: OPDP Issues First Letter in 2024 for Unlawful Promotion

Better Than Ezra’s early 1990s single, “This Time of Year,” came to mind when we saw the Food and Drug Administration’s Office of Prescription Drug Promotion issue its first Untitled Letter (also known as a Notice of...more

1/24/2024 / Advertising , Food & Drug Regulations , Food and Drug Administration (FDA) , Life Sciences , Marketing , OPDP , Pharmaceutical Industry , Prescription Drugs

It's a Heartache: FDA's OPDP Issues an Untitled Letter for Unlawful Promotion of a Cholesterol-Lowering Drug Product

“It’s a Heartache, Nothing But a Heartache.” Yes, the opening lyrics to Bonnie Tyler’s 1977 hit, but also what might have been felt in FDA’s Office of Prescription Drug Promotion when it issued an Untitled Letter to a drug...more

6/23/2022 / Advertising , Enforcement Actions , FDA Warning Letters , Food & Drug Regulations , Food and Drug Administration (FDA) , Healthcare , Life Sciences , Marketing , Misleading Statements , OPDP , Pharmaceutical Industry , Prescription Drugs

Out of Touch: FDA Takes Exception With Drug Company’s Promotion for Topical Drug Product

Who doesn’t remember Hall and Oates’ 1984 hit, “Out of Touch?” Perhaps, reviewers in the Food and Drug Administration’s Office of Prescription Drug Promotion were humming this song when it recently issued an Untitled Letter...more

4/18/2022 / Advertising , Direct to Consumer Sales , Enforcement Actions , Food & Drug Regulations , Food and Drug Administration (FDA) , Healthcare , Life Sciences , Marketing , Misleading Impressions , OPDP , Pharmaceutical Industry , Prescription Drugs , Television Commercials

AGG Food & Drug Newsletter - March 2022

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

3/28/2022 / 510(k) RTA , Cosmetics , FDA Warning Letters , Food & Drug Regulations , Food and Drug Administration (FDA) , Healthcare , Investigational New Drug Application (IND) , Life Sciences , OPDP , Personal Care Products , Pharmaceutical Industry , Prescription Drugs , Regulatory Reform , Regulatory Requirements

Don’t Go Changing . . . Unless You Ask FDA

The Food and Drug Administration recently issued a Warning Letter to a medical device manufacturer for making significant changes to its 510(k)-cleared products for uses outside the scope of the 510(k) clearance, among other...more

3/15/2022 / 510(k) RTA , FDA Warning Letters , Food & Drug Regulations , Food and Drug Administration (FDA) , Healthcare , Life Sciences , Medical Devices , Pharmaceutical Industry

Roll With the Changes: FDA’s Proposed Amendments to Converge its Quality Management System Requirements With ISO Requirements

In the words of the rock band REO Speedwagon, from the 1978 song “Roll with the Changes,” “It had to happen, felt the tables turnin’.” Earlier this month, the Food and Drug Administration’s Device Good Manufacturing Practice...more

3/15/2022 / Comment Period , Food & Drug Regulations , Food and Drug Administration (FDA) , Healthcare , ISOs , Life Sciences , Medical Devices , Pharmaceutical Industry , Proposed Rules , Regulatory Agenda , Regulatory Reform

Slow Down, You Move Too Fast: OPDP Issues a Warning Letter for Promoting an Investigational New Drug

In 1966, Simon & Garfunkel sang “The 59th Bridge Song,” which opens with the lyric, “Slow down, you move too fast.” A drug company recently found out the hard way that pre-approval promotion does not leave the Food and Drug...more

2/25/2022 / Advertising , Enforcement Actions , FDA Approval , FDA Warning Letters , Food & Drug Regulations , Food and Drug Administration (FDA) , Healthcare , Investigational New Drug Application (IND) , Life Sciences , Marketing , Misleading Statements , OPDP , Pharmaceutical Industry , Prescription Drugs

AGG Food & Drug Newsletter - January 2022