The US Food and Drug Administration (FDA) has issued a draft guidance to assist “responsible persons” that are required to submit a cosmetic manufacturing facility registration and cosmetic product listing under the...more
In a continuing effort to improve the quality system effectiveness of human drug manufacturing sites, FDA revised MAPP 5014.1, Understanding CDER’s Risk-Based Site Selection Model (Site Selection MAPP or the Policy)....more
The US Consumer Product Safety Commission (CPSC) will take a hard and fast approach to product safety in FY23, according to its recently passed operating plan, with enforcement being at the top of its priority list....more
On October 17, 2022, the US Food and Drug Administration (FDA) implemented revisions to two of its compliance policy guides (CPGs). CPGs are intended to advise FDA staff as to the agency's strategy when assessing and...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
The Federal Trade Commission (FTC) recently issued a final rule that marks a major shift in the regulatory landscape for labeling that has already begun to impact other regulatory bodies—namely, the US Department of...more
January was a busy month for the US Food and Drug Administration’s precision medicine efforts, as the agency produced guidance on ASO drugs for patients with debilitating or life-threatening genetic disorders and guidance on...more
The coronavirus (COVID-19) pandemic continues to impact the biopharmaceutical industry. In a recent guidance, Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency (the...more
As the coronavirus (COVID-19) pandemic resurges, PREP Act liability immunity continues to be critical for manufacturers and users of COVID-19 medical products. ...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
In light of the hand sanitizer shortage during the coronavirus (COVID-19) pandemic, many manufacturers are seeking alternative sources of alcohol for incorporation into their hand sanitizer products. The need for alcohol has...more
The US Supreme Court held on May 20 that a judge, not a jury, must decide the question of whether federal law prohibited drug manufacturers from adding warnings to the drug label that would satisfy state law. To succeed on a...more
6/3/2019
/ Agency Disapproval ,
Clear Evidence Standard ,
Failure To Warn ,
FDA Approval ,
Federal v State Law Application ,
Food and Drug Administration (FDA) ,
Judicial Authority ,
Jury Trial ,
Manufacturers ,
Merck Sharp & Dohme Corp. v. Albrecht ,
Preemption ,
Prescription Drugs ,
Question of Fact ,
Question of Law ,
Remand ,
SCOTUS ,
State Law Claims ,
Vacated ,
Warning Labels
Court holds that FDA guidance cannot require preapproval for label modifications to existing tobacco products, but can require preapproval for quantity modifications....more
The draft guidance provides insight into FDA’s expectations regarding data controls and compliance for pharmaceutical companies.
In recent years, issues involving the integrity of and controls around manufacturing data...more
Proposed requirements dictate a substantial upgrade of the current regulatory standard of care.
On October 29, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed rule—Current Good Manufacturing...more