On July 8, the U.S. Food and Drug Administration (“FDA”) announced its updated guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” which provides recommendations and...more
The advent of the COVID-19 rapid antigen test launched at-home diagnostics to the forefront of conversation in the life sciences industry. Many believe this is only the beginning. As the share of telehealth services...more
On May 17, the U.S. Food & Drug Administration (“FDA”) issued two important draft guidance documents, which clarify the agency’s approach to requirements and incentives in the realm of pediatric drug development — “Regulatory...more
Am I making a “cosmetic product”? If you are a manufacturer, packer, importer, or distributor, the first question you should be asking is whether your product falls under the definition of a “cosmetic product,” which...more
At the beginning of February, the US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) appointed Professor Kevin Fu as the first ever Acting Director of Medical Device Cybersecurity. Fu’s...more
Major legislation impacting FDA often accompanies user fee reauthorizations every 5 years. However, Congress has acted to address public health issues between user fee cycles. FDA regulates 20¢ of every U.S. consumer dollar...more
On Tuesday, FDA announced the entry of a consent decree of permanent injunction against Keystone Laboratories, Inc. of Memphis, Tennessee for manufacturing OTC hair care and skin care products in violation of Current Good...more
On September 13, the U.S. House of Representatives Energy and Commerce Committee’s Subcommittee on Health held a hearing to examine draft legislation to create a new user fee program and completely revamp the review process...more
Last week, the Senate Committee on Health, Education, Labor and Pensions (HELP Committee) advanced the Food and Drug Administration (FDA) Reauthorization Act of 2017 (S. 934), by a vote of 21–2. ...more
In a final rule published on Sept. 6, 2016, the U.S. Food and Drug Administration (FDA) reassessed its risk-benefit analysis for consumer antiseptic washes (antibacterial hand and body washes) and found that the evidence in...more
Continuing a discussion that began in 2014, on June 10, 2016 FDA hosted a public meeting on the potential development of a user fee program for OTC (over-the-counter, or nonprescription) drug products marketed pursuant to the...more
I. REGULATIONS, NOTICES, & GUIDANCE - On April 4, 2016, the Centers for Medicare & Medicaid Services (CMS) issued the Final Calendar Year (CY) 2017 Medicare Advantage Capitation Rates and Medicare Advantage (MA) and...more
As our readers know, we write about legal developments that affect companies involved in manufacturing, importing, distributing, and/or selling “consumer products.” In many cases, these products fall squarely within the...more