Spurred by a March 5, 2024 citizen petition to the Food and Drug Administration (FDA), a flurry of class action complaints have been filed claiming that drug makers failed to warn consumers about the presence of benzene in...more
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) brought significant changes for the US Food and Drug Administration’s (FDA’s) regulation of cosmetic products. Recent FDA action, including the issuance of final...more
The US Food and Drug Administration (FDA) was busy in 2023 with significant, and even bullish, developments occurring across several areas, from drug and biologic development and manufacturing to labeling, advertising, and...more
The US Food and Drug Administration (FDA) has issued a draft guidance to assist “responsible persons” that are required to submit a cosmetic manufacturing facility registration and cosmetic product listing under the...more
FDA recently published a Federal Register notice announcing a public listening session on good manufacturing practices (GMPs) for cosmetic products under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which...more
While the Biden administration and US Congress continue to debate ways to address perceived prescription drug pricing concerns, the Food and Drug Administration (FDA) is taking action. Under its Drug Competition Action Plan...more
A bipartisan group of lawmakers in the US House of Representatives’ Judiciary Antitrust Subcommittee recently voted three bills out of committee that target the pharmaceutical industry practices of so-called “reverse...more
8/16/2021
/ AMG Capital Management LLC v FTC ,
Antitrust Violations ,
Biosimilars ,
Competition ,
Exclusive Licenses ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
FTC Act ,
Generic Drugs ,
Hatch-Waxman ,
Manufacturers ,
Noerr-Pennington Doctrine ,
Pharmaceutical Industry ,
Reverse Payment Settlement Agreements
In a May 27 Federal Register notice, the US Department of Health and Human Services (HHS) announced the reinstatement of the Unapproved Drugs Initiative, the FDA’s compliance policy governing marketed unapproved drugs. The...more
In an apparent effort to combat prescription drug shortages and price spikes, the US Department of Health and Human Services (HHS) recently announced the forthcoming termination of FDA’s Unapproved Drugs Initiative (UDI). ...more
The $2 trillion economic stimulus package laid out in the Coronavirus Aid, Relief, and Economic Security (CARES) Act includes $11 billion in appropriations for vaccines, therapeutics, and other medical needs, and $34.9...more
4/5/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Drug Distribution ,
Federal Loans ,
Financial Stimulus ,
Food Manufacturers ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Distribution ,
Pharmaceutical Industry ,
Prescription Drugs ,
Relief Measures ,
Small Business ,
Suppliers
During the coronavirus (COVID-19) outbreak, FDA guidance allows healthcare providers to prescribe drugs subject to Risk Evaluation and Mitigation Strategies without conducting the required laboratory tests or imaging studies....more
Now is the time for pharmaceutical manufacturers to review their Open Payments/Sunshine Act internal compliance procedures, data collection forms and databases, and reporting and recordkeeping templates for payments and...more
The documents issued by the US Food and Drug Administration on shared system risk evaluation and mitigation strategies signal the FDA’s willingness to grant waivers from the shared program requirement, but that may complicate...more
New authority allows FDA inspectors to quickly detain products during inspections if they believe the products are misbranded or adulterated....more