Last month the United States Food and Drug Administration (“FDA”) issued its final guidance (“Guidance”) for the industry on cosmetic product facility registrations and product listings, as required by the Modernization of...more
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On Oct. 23, the FDA issued draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses [SIUU] of Approved/Cleared Medical Products: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
The FDA has announced the formation of the Digital Health Advisory Committee, a group dedicated to navigating the complexities of emerging DHTs like AI/ML, augmented reality and more. This development evidences the FDA’s...more
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On August 7, 2023, the U.S. Food and Drug Administration (FDA, the Agency) published draft guidance aimed at assisting cosmetics companies with achieving and maintaining compliance with new cosmetic product facility...more
8/16/2023
/ Comment Period ,
Compliance ,
Cosmetics ,
Draft Guidance ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Labeling ,
Manufacturers ,
Personal Care Products ,
Product Packaging ,
Registration Requirement ,
Safety Standards
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27, 2023 the FDA published Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry. In this draft guidance, FDA provides examples of activities prohibited...more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Draft Guidance ,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
On March 13 the FDA officially issued a Federal Register notice to explain how the end of the COVID-19 PHE declaration will impact the Agency’s 72 COVID-related guidance documents currently in effect. The notice comes as the...more
On March 6, the FDA announced the launch of its new “Dietary Supplement Ingredient Directory.” According to the FDA, the directory is “a one-stop shop of ingredient information that was previously found on different FDA...more
Key Takeaways:
..FDA created a new category for voluntary firm registration after NECC compounding fungal meningitis outbreak in 2012.
..Individuals face criminal liability for misrepresentations made to FDA....more
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 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
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