On March 31, 2020, the United States Food and Drug Administration (FDA) issued guidance surrounding notification procedures if a manufacturer suffers a permanent discontinuance or interruption in manufacturing under the...more
Recently, a New York-based dietary supplement manufacturer (and its subsidiaries) issued a nationwide recall of all lots of dietary supplement products manufactured and sold between January 2013-November 2019. Because the...more
2/12/2020
/ CGMP ,
Consent Decrees ,
Department of Justice (DOJ) ,
Dietary Supplements ,
Drug Compounding ,
Due Diligence ,
Enforcement Actions ,
FDA Warning Letters ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Inspections ,
Manufacturers ,
Patent Infringement ,
Product Recalls
With its recent issuance of additional warning letters and the release of a consumer update, the Food and Drug Administration (FDA) appears to be signaling that it will continue its deliberate approach in determining an...more
11/27/2019
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Dietary Supplements ,
FDA Warning Letters ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Health and Safety ,
Hemp ,
Hemp Cultivation ,
Interim Final Rules (IFR) ,
Regulatory Agenda ,
USDA
Introduction: Citizen Petitions in the News -
Citizen petitions and stay of action petitions (collectively, citizen petitions or petitions) are in the news. Formally, citizen petitions are a mechanism for "interested...more
11/7/2019
/ Abbreviated New Drug Application (ANDA) ,
Administrative Proceedings ,
Anti-Competitive ,
Biosimilars ,
Citizen Petitions ,
Dietary Supplements ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Noerr-Pennington Doctrine ,
Public Health ,
Sham Citizen Petitions
Navigating the U.S. Healthcare Regulatory Landscape for Wearable Devices -
Complex Environment Includes Key Federal Agencies FDA, FTC, OCR, CPSC, CMS, and OIG -
The wearable device market is emerging as a key player...more
6/19/2019
/ Biotechnology ,
California Consumer Privacy Act (CCPA) ,
Centers for Medicare & Medicaid Services (CMS) ,
Consumer Product Safety Commission (CPSC) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
FTC Act ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
Technology-Assisted Review ,
Telemedicine ,
Value-Added Services
Dietary supplements are big business. Three out of four Americans take a dietary supplement, and the rate rises to four out of five among older Americans. Dietary supplements are a $40 billion dollar industry, with between...more
Dietary supplements are big business. A recent estimate pegs the U.S. market for dietary supplements at over $35 billion annually. The U.S. Food and Drug Administration (FDA) estimates the number of dietary supplements to be...more
On August 7, 2015, the U.S. District Court for the Southern District of New York released its Amarin opinion addressing whether truthful, non-misleading off-label promotion of U.S. Food and Drug Administration (FDA)-approved...more
8/12/2015
/ Abbott Laboratories ,
Allergan Inc ,
Amarin ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
GlaxoSmithKline ,
Off-Label Promotion ,
Pharmaceutical Industry ,
Prescription Drugs
Personal care products, which include cosmetics, are a large, profitable, growth industry. In the United States, cosmetics are regulated by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug & Cosmetic...more