On Jan. 15, 2021, the U.S. Department of Health & Human Services (HHS) issued a notice, “Making Permanent Regulatory Flexibilities Provided During the COVID-19 Public Health Emergency by Exempting Certain Medical Devices From...more
On Dec.30, 2020, the Department of Health and Human Services (HHS) Office of the General Counsel released an advisory opinion concluding that drug manufacturers are obligated to deliver discounts under the 340B Drug Pricing...more
On Dec. 11, the U.S. Food and Drug Administration (FDA) issued the first emergency use authorization (EUA) for a vaccine for the prevention of the coronavirus disease 2019 (COVID-19). An EUA differs from an approval in that...more
On Dec. 10, the United States Supreme Court issued its ruling in Rutledge v. Pharmaceutical Care Management Association. The Court reversed the 8th Circuit to uphold a state’s ability to regulate the price at which pharmacy...more
12/14/2020
/ Drug Pricing ,
Employee Retirement Income Security Act (ERISA) ,
Health Insurance ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Preemption ,
Prescription Drug Coverage ,
Prescription Drugs ,
Rutledge v Pharmaceutical Care Management Association ,
SCOTUS
The U.S. Food and Drug Administration (FDA) recently released the Draft Guidance for Industry, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research. In this guidance, the FDA defers to the...more
8/11/2020
/ Cannabis Products ,
Clinical Trials ,
Controlled Substances Act ,
DEA ,
Draft Guidance ,
Drug Compounding ,
Farm Bill ,
Food and Drug Administration (FDA) ,
Medical Research ,
Pharmaceutical Industry ,
Prescription Drugs
This update approaches three months of coverage of the Food and Drug Administration (FDA) and related regulatory response to COVID-19. Updates and developments continue in the COVID-19 response despite a decrease in media...more
Efforts to increase testing are occurring at the national and state levels. The Food and Drug Administration (FDA) continues to crack down on firms marketing products – including drugs, testing kits and personal protective...more
With this update, we have covered and provided Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and state boards of pharmacy actions related to COVID-19 for more than one month. This update will...more
The medical device industry and the Food and Drug Administration (FDA) have been experimenting with three-dimensional (3D) printing for years. Shortages of medical devices such as personal protective equipment (PPE) and...more
Multiple regulatory agencies continue to do their part in the fight against COVID-19. This week, the U.S. Drug Enforcement Administration (DEA) and Food and Drug Administration (FDA) and state boards of pharmacy all acted to...more
Shortages of gloves, gowns, face masks, respirators, ventilators, drugs and hand sanitizer continue to be reported. The crackdowns on prescribing of chloroquine and hydroxychloroquine, currently being studied to treat...more
In response to the COVID-19 outbreak in the United States, the Food and Drug Administration (FDA) has issued an increasing number of EUAs, now in the double digits, for in vitro diagnostic (IVD) products and personal...more
The U.S. now has the most confirmed coronavirus cases in the world, and the FDA and state boards of pharmacy are issuing daily guidance on how to stop the spread or join in the fight through relaxed standards or expedited...more
3/30/2020
/ Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Safety ,
Manufacturers ,
Medical Devices ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Pharmacies ,
Restaurant Industry ,
Veterinarians
Hand sanitizer, critical infrastructure, drug shortages and Emergency Use Authorizations (EUAs) are the FDA updates on COVID-19 over the weekend....more
The Food and Drug Administration (FDA) and the state boards of pharmacy continue to issue guidance and policy daily. Now, the Drug Enforcement Administration (DEA) has joined in to provide guidance to industry and healthcare...more
Here, we provide you with the first update to important actions in the life sciences sector that the Food and Drug Administration (FDA) and state boards of pharmacy are taking to address the pandemic so far. ...more
The new coronavirus continues to be the leading global news headline. We have established a comprehensive online resource center to help address and answer legal questions about coronavirus disease 2019 (COVID-19). ...more
With just days remaining until the “Deemed to Be a License” transition takes effect, the FDA issued an unexpected sweeping change to compounding practice. ...more
Food/Dietary Supplements -
FDA Announces Proposed Information Collections – The Notice “announces the FDA information collection request from the OMB for a generic clearance that will allow FDA to use qualitative...more
Food/Dietary Supplements -
FDA Publishes Guidance on Nutrition and Supplement Facts Labels – The FDA “prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement...more
Food/Dietary Supplements -
FDA Provides Update on Frozen Berry Sampling – The FDA stated, “As of September 30, 2019, the FDA has tested 339 domestic samples and 473 import samples of frozen berries. ...more
Food/Dietary Supplements -
FDA Issues Statement on E. coli in Lettuce – FDA issued an update to the E. coli O157:H7 illnesses linked to romaine lettuce....more
Food/Dietary Supplements -
Court Enters Consent Decree Against Food Facility – A Michigan-based food manufacturer will “discontinue selling food products until the company complies with federal regulations and other...more
Food/Dietary Supplements -
FDA Releases Final Serving Size Guidance – The guidance is intended to “help manufacturers of packaged foods comply with the FDA’s updated Nutrition Facts labeling regulations. ...more
Food/Dietary Supplements -
FDA Warns Consumers Not to Use Certain Products Following Consent Decree – The FDA issued a warning to consumers to steer clear of certain drug, dietary supplement and medical device products...more