On Jan. 5, the FDA authorized Florida’s Section 804 Implementation program (SIP), making Florida the first state to secure such approval.
Generally, there are three pathways to importing a prescription drug into the United...more
On Oct. 23, the FDA issued draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses [SIUU] of Approved/Cleared Medical Products: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
Concerns have grown tremendously in recent years regarding noncompliance in clinical trial reporting. Shockingly, the National Institutes of Health (NIH) failed to disclose the results of over one-third of the clinical trials...more
8/23/2023
/ Clinical Trials ,
Compliance ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Medical Research ,
National Institute of Health (NIH) ,
OIG ,
Pharmaceutical Industry ,
Registration Requirement ,
Reporting Requirements ,
Sponsors
On June 27, 2023 the FDA published Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry. In this draft guidance, FDA provides examples of activities prohibited...more
6/29/2023
/ Comment Period ,
Draft Guidance ,
Drug Compounding ,
Food and Drug Administration (FDA) ,
Hospitals ,
Outsourcing ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Supply Chain ,
Wholesale
On May 10, the U.S. Food and Drug Administration (FDA) published a discussion paper, “Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products.” The paper is a collaboration between...more
5/15/2023
/ Artificial Intelligence ,
Biologics ,
Center for Biologics Evaluation and Research (CBER) ,
Center for Drug Evaluation and Research (CDER) ,
Discussion Draft ,
Food and Drug Administration (FDA) ,
GAO ,
Life Sciences ,
Machine Learning ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Research and Development
The U.S. Court of Appeals for the Third Circuit is currently hearing arguments from pharmaceutical manufacturers Novo Nordisk, Sanofi and AstraZeneca and the Department of Health and Human Services (HHS) on whether the 340B...more
11/22/2022
/ AstraZeneca ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Medicare ,
Novo Nordisk ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Sanofi ,
Section 340B
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. 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
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
Food - FDA Released Retail Food Employee Health Handbook – The FDA published the Employee Health and Personal Hygiene Handbook to help food employees avoid spreading viruses and bacteria to food....more
11/2/2020
/ Biosimilars ,
Coronavirus/COVID-19 ,
Employee Handbooks ,
Food and Drug Administration (FDA) ,
Food Safety ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacist ,
Product Labels ,
Supply Chain ,
Vaccinations
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
Food - FDA Released Final Rule on Gluten-Free Labeling – The final rule establishes compliance requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, that use the...more
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
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
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
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
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
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