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
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