On Oct. 23, the FDA issued draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses [SIUU] of Approved/Cleared Medical Products: Questions and Answers,”...more
11/6/2023
/ Comment Period ,
Communication Restrictions ,
Evidentiary Standards ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medical Devices ,
New Guidance ,
Pharmaceutical Industry ,
Public Comment ,
Scientific Evidence
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
Food - FDA Releases Resources on Food Traceability Proposed Rule – The FDA released a resource to allow users to explore the results of the Risk-Ranking Model for Food Tracing used in the development of the Food Traceability...more
11/20/2020
/ Biologics ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Fraud ,
Healthcare Fraud ,
Manufacturers ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Virus Testing
FDA Released Food Traceability Proposed Rule – The United States Food and Drug Administration (FDA) is proposing to establish additional traceability recordkeeping requirements for manufacturers, processors, packers or...more
10/9/2020
/ DEA ,
Food and Drug Administration (FDA) ,
Food Safety ,
Imports ,
Medical Devices ,
Pharmaceutical Industry ,
Product Labels ,
Recordkeeping Requirements ,
Seafood ,
Supply Chain ,
Tobacco ,
USDA
Food - Hemp Production Program Comment Period Reopened – The U.S. Department of Agriculture (USDA) is providing an additional 30 days for public comments on the interim final rule that established a domestic hemp production...more
FDA Plans to Restart On-Site Inspections the Week of July 20 -Commissioner Hahn announced the goal of restarting inspections, which were halted due to COVID-19. The FDA has developed a COVID-19 Advisory Rating system to...more
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
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 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
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
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
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
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
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