While the US Court of Appeals for the Fifth Circuit has temporarily stayed the Texas district court’s ruling invalidating the US Food and Drug Administration’s (FDA’s) approval of mifepristone, the decision will still...more
The US Food and Drug Administration recently issued an order authorizing R.J. Reynolds Vapor Co. to market its Vuse Solo electronic nicotine delivery system and corresponding e-liquid pods. These authorizations mark the first...more
As the world awaits a successful COVID-19 vaccine, employers are beginning to consider the implications a new vaccine will have on their workplaces. Although much remains speculative, employers can look to the regulation of...more
11/10/2020
/ Americans with Disabilities Act (ADA) ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
Employer Liability Issues ,
Equal Employment Opportunity Commission (EEOC) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
OSHA ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Title VII ,
Trump Administration ,
Vaccinations ,
Workers' Compensation Claim
From the beginning of the coronavirus (COVID-19) pandemic, FDA actively provided guidance to members of the drug and biologic industries, including sponsors, investigators, pharmacies, and compounders....more
7/1/2020
/ Biologics ,
Biosimilars ,
CGMP ,
Clinical Trials ,
Coronavirus/COVID-19 ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Life Sciences ,
National Institute of Health (NIH) ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regulatory Requirements ,
Research and Development
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
Amarin is an important US district court opinion affirming the importance of the Second Circuit’s Caronia decision and finding that pharmaceutical and medical device companies have a constitutionally protected right to...more
8/11/2015
/ Amarin ,
Caronia ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Misbranding ,
Off-Label Promotion ,
Pharmaceutical Industry ,
Physicians ,
Preliminary Injunctions ,
Prescription Drugs