Todd Rundgren’s 1978 classic, “Can We Still Be Friends?” (arguably, his best song), came to mind when we saw that the Food and Drug Administration issued a draft guidance, “Formal Dispute Resolution and Administrative...more
“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
FDA has recently published two much-anticipated items related to artificial intelligence (“AI”), one pertaining to medical devices and the other to drug manufacturing. FDA has cleared or approved hundreds of products that...more
Last month, the Food and Drug Administration’s Office of Orphan Products Development (“OOPD”) found that one prescription drug company was able to, essentially, breach another’s orphan drug exclusivity (and have its new drug...more
Many of us remember the television commercial where an older woman falls and cries out, “Help! I’ve fallen and I can’t get up.” This image and quote came to our mind when FDA recently issued a Warning Letter to a medical...more
Recently, a medical device company received a Warning Letter from FDA for a number of quality-related deficiencies, including issues with Medical Device Reporting (“MDR”), the promptness (or lack thereof) of handling and...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a roundup 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
Channeling Joe Jackson’s 1982 catchy hit, “Steppin’ Out,” the National Advertising Division (“NAD”) of the BBB National Programs recently released a decision regarding a prescription drug advertisement, resulting in the...more
Recently, the Food and Drug Administration published a Notification to clarify its policy about orphan drug exclusivity. The agency issued the announcement because the U.S. Court of Appeals for the 11th Circuit found that FDA...more
Recently, the Food and Drug Administration published a revision to its final guidance document titled, “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices,” originally issued...more
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
“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
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
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
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
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
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
Please join AGG Food & Drug attorneys Alan G. Minsk and Laura S. Dona for a complimentary webinar reviewing past FDA letters issued to pharmaceutical and medical device companies for unlawful promotion in 2021 and where FDA...more
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
2/1/2022
/ Advertising ,
Biden v Missouri ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Employer Mandates ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Workers ,
Infectious Diseases ,
Life Sciences ,
Medical Devices ,
National Federation of Independent Business v Department of Labor and OSHA ,
OPDP ,
Opioid ,
OSHA ,
Pharmaceutical Industry ,
Prescription Drugs ,
Supply Chain ,
Vaccinations
Late last year, the Food and Drug Administration’s Office of Prescription Drug Promotion issued an Untitled Letter to a drug company for unlawful promotion of its biologic product....more
1/25/2022
/ Advertising ,
Biologics ,
Direct to Consumer Sales ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Marketing ,
Misleading Impressions ,
OPDP ,
Pharmaceutical Industry ,
Prescription Drugs ,
Television Commercials
Many of us remember the Seinfeld episode where the owner of a soup restaurant refuses to fulfill an order if the consumer talks back or otherwise upsets him, angrily stating, “No soup for you.” Recently, the Food and Drug...more
With a nod to the Electric Light Orchestra’s 1976 song, “Telephone Line,” the Drug Enforcement Administration (“DEA”) issued an Advanced Notice of Proposed Rulemaking (“ANPR”) regarding the practice of telepharmacy. The...more
Recently, the Food and Drug Administration issued a draft guidance, “Content of Premarket Submissions for Device Software Functions,” to help industry understand what it should include in regulatory marketing submissions to...more
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
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