Manufacturers, Enforcement, Prescription Drugs

FDA Drafts Guidance on Correcting “Misinformation”

Gardner Law on 8/6/2024

The U.S. Food and Drug Administration (FDA) recently released draft guidance on how and when medical device manufacturers and pharmaceutical companies can respond to misinformation about their products online. While not yet...more

Navigating HIPAA and State Privacy Laws for Drug and Device Manufacturers

Gardner Law on 6/12/2024

The Health Insurance Portability and Accountability Act of 1996 as amended and implemented through regulations at 45 C.F.R. §§ 160 and 164 (“HIPAA”) regulates the privacy and security of health information. For drug and...more

FDA’s Final Rule on Direct-to-Consumer Advertising – Presentation of Risk Information

Foley & Lardner LLP on 12/7/2023

In November 2023, the U.S. Food and Drug Administration (FDA) published its final rule (Rule) to amend its regulations concerning radio and television direct-to-consumer (DTC) advertisements (ads) for human prescription drugs...more

New WA Privacy Law ‘Turns The Beat Around’ on Drug and Device Makers

Gardner Law on 6/14/2023

The Washington My Health My Data Act ("MHMDA") may not have been written by Earth, Wind, & Fire, but it is certainly poised to make medical device and pharmaceutical manufacturers move to a new beat like a classic disco hit....more

FDA Issues First Untitled Letter of the Year to HCT/P Manufacturer

Sheppard Mullin Richter & Hampton LLP on 3/30/2023

On March 1, 2023, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) published its first untitled letter of the year to Thomas Advanced Medical LLC (Thomas) for marketing...more

Are you Ready for Inspection? Best Practices to “Survive” FDA Inspections

Gardner Law on 8/25/2022

Companies often come to Gardner Law when they feel anxious or unprepared for a visit from the Food and Drug Administration (FDA). Even experienced companies with strong quality systems sometimes need assistance to be fully...more