Instead of sending a turkey and cranberry sauce, in the spirit of 2020 where nothing is normal, the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) made a different delivery this year for...more
On November 20, 2020, the United States Department of Health and Human Services (HHS) issued a Federal Register notice to: (1) withdraw the Food and Drug Administration’s (FDA) Compliance Policy Guide (CPG) Sec. 440.100...more
A few weeks ago, AGG’s Food and Drug Practice Team launched its podcast series to discuss topics affecting the FDA-regulated industry. The series, called “I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues,”...more
AGG is pleased to present the second episode in a podcast series titled, “I Wish I Know What I Know Now: Conversations with AGG on FDA Issues,” covering key due diligence issues to consider when acquiring or investing in life...more
Some of us remember radio stations playing two songs from the same artist or band, back to back, with the alliterative “Two for Tuesday” slogan. The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP)...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug practice....more
AGG is proud to introduce our newest podcast series titled “I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues.” Each month, we will release a new podcast where different members of our Food and Drug practice...more
On August 31, 2020, the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) sent a Warning Letter to the sponsor of a drug for a violative direct-to-consumer (DTC) radio advertisement.1 The radio...more
Over the past few months, several clients have alerted us to the delayed or discontinued status of their clinical trials due to the COVID-19 pandemic. Studies typically conducted in physicians’ offices, clinics, or hospitals...more
Maybe it’s a product that you’ve imported into the U.S. dozens of times. Maybe this is your first time importing this product or you’re working with a new business partner. Maybe you’re very familiar with the process, or...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug practice....more
The Food and Drug Administration’s Office of Prescription Drug Promotion isn’t letting the Dog Days of Summer stop it from taking action against what it perceives as unlawful marketing. In its first Untitled Letter of 2020...more
The Red Rocker, Sammy Hagar, sang in 1984, “I Can’t Drive 55.” When counseling clients at our Firm about the potential of enforcement risk by the Food and Drug Administration (or any other regulatory authority for that...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug practice....more
Al Stewart’s 1970s song, “On the Border,” comes to mind every so often when an existing or new client contacts us as their product is stopped at the United States border by the Food and Drug Administration. Lately, during...more
The Food and Drug Administration issued a Warning Letter to a medical device company after conducting an inspection of the facility’s medical device operations....more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug practice....more
The FDA Reauthorization Act of 2017 (FDARA) created a new pathway to incentivize the development of generic drugs where there is inadequate competition. Under this new pathway [new Section 506H of the Federal Food, Drug, and...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug practice....more
In response to the COVID-19 pandemic, the Food and Drug Administration issued a guidance document on non-invasive remote monitoring devices to assist in facilitating patient monitoring during the COVID-19 public health...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug Practice....more
On March 13, 2020, Eagle Pharmaceuticals, Inc. refused to “take it easy” (yes song lyric pun included) against the Food and Drug Administration when it took a stand and prevailed in a court case against the agency concerning...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug Practice. ...more
On February 3, 2020, the Food and Drug Administration’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research issued jointly a draft guidance entitled, “Promotional Labeling and Advertising...more
AGG recently presented a webinar on “FDA Regulation of Rx Drug and Medical Device Advertising & Promotion: The Year in Review.” The webinar focused primarily on an in-depth review of the enforcement letters issued by FDA to...more