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On August 7, 2023, the U.S. Food and Drug Administration (FDA, the Agency) published draft guidance aimed at assisting cosmetics companies with achieving and maintaining compliance with new cosmetic product facility...more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Draft Guidance ,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
The U.S. Food and Drug Administration (FDA) has issued new guidance to the medical device industry on the importance of cybersecurity measures in product development. ...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
In an unprecedented time amid the global COVID-19 pandemic, an increasing number of pharmaceutical manufacturers and developers of active pharmaceutical ingredients are involved in the potentially life-saving development of...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
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
Vermont recently became the first state to require drug manufacturers to provide justification for price increases. Under the new law, data on the cost of the drug will come from the state Medicaid program. The Department of...more
The Food and Drug Administration (FDA) is reopening the comment period for two draft social media guidances in response to requests for additional time to allow interested persons to submit comments. Beginning September 29,...more
The U.S. Food and Drug Administration (FDA) has released five policy documents regarding compounded human drug products in connection with its continued implementation of the compounding provisions of the Drug Quality and...more