Food - FDA Is Investigating an Outbreak of Cyclospora in Bagged Salads – The FDA is investigating a multistate outbreak of cyclospora infections potentially linked to salad products....more
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
Food - FDA Published Report on 2019 E. Coli Outbreak in Romaine Lettuce – The report provides an overview of the investigation approach and factors that potentially contributed to the contamination of romaine lettuce with E....more
Food - FDA Seeks Comment on the Proposed Collection of Information on Reportable Food – Reportable food is an article of food (other than infant formula) for which there is a reasonable probability that the use of or exposure...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
Food - FDA Extended Comment Period for Rule on Food Standards – The comment period on the proposed rule was extended until July 20. The proposed rule, “Food Standards; General Principles and Food Standards Modernization,”...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
Food - Investigations Are Ongoing Into Recalled Mushrooms – FDA, CDC, and state and local partners are currently investigating a multistate outbreak of Listeria monocytogenes infections linked to enoki mushrooms. FDA...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
Cosmetics - FDA Requested Comments on Information Collection for Cosmetics – FDA announced it is seeking comment on information collection activities regarding FDA’s cosmetic labeling regulations and its Voluntary Cosmetic...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
As the response to COVID-19 consumes more and more healthcare, industry and regulatory resources, developments in the FDA and pharmacy space not relating to COVID-19 are limited. When other developments are available, the FDA...more
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
Coronavirus (COVID-19) -
The FDA and Pharmacy Weekly Digest will continue to provide weekly coverage of the FDA and the pharmacy sector during the current public health emergency....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
FDA Launched Webpage on Agricultural Biotechnology – The webpage is part of the Feed Your Mind education initiative to help consumers better understand genetically engineered foods, commonly called GMOs or genetically...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 Extended the Comment Period for the Laboratory -
Accreditation Program Proposed Rule – Once the laboratory accreditation program is established, the FDA will require that the testing of food...more
Food/Dietary Supplements -
FDA Released a Supplemental Draft Guidance for the Intentional Adulteration Rule Under the Food Safety Modernization Act – The Food & Drug Administration (FDA) announced the availability of a...more
Food/Dietary Supplements -
FDA and CDC Announced the End of a Salmonella Outbreak in Fresh Fruit – The Food & Drug Administration (FDA) completed its investigation into an outbreak of illnesses caused by Salmonella that...more