Presentation of Risks in DTC Video, HCP Webpage Yields Enforcement Letter for Bausch Health
April 18, 2022 – A recent enforcement letter from the Food and Drug Administration’s (FDA’s) Office of Prescription Drug Promotion (OPDP) to
April 18, 2022 – A recent enforcement letter from the Food and Drug Administration’s (FDA’s) Office of Prescription Drug Promotion (OPDP) to
Feb. 28, 2022 – Comments made in a video interview by CytoDyn Inc.’s former president and CEO suggesting that the investigational new drug (IND)
Jan. 31. 2022 – Presenting drug benefit information without also including risk information in a social media post on Instagram misbrands Eli
Dec. 13, 2021 – Recent FDA Warning Letters calling out promotional claims made about vaping products are interesting in that they were issued not
July 26, 2021 – The FDA’s Office of Prescription Drug Promotion cited Amgen for making misleading claims that the delivery of its product
The U.S. Food and Drug Administration (FDA) is in full enforcement mode issuing 260 warning letters in 2021 alone! Now is the time to ensure your
May 3, 2021 – Although the Food and Drug Administration (FDA) has issued more than 40 “Pre-Notices of Noncompliance” to companies to encourage
Feb. 23, 2021 – Amid a surge in opioid overdose deaths over the past year – due in part to the ongoing COVID-19 pandemic and its corresponding
Dec. 14, 2020 – In a recent Untitled Letter, the FDA’s Office of Prescription Drug Promotion (OPDP) states that claims made by Azurity
It is time to look back at enforcement for the 2019 year. It is still possible that FDA could post another letter, as there is a lag time between
Happy New Year! It is 2020 – the year of clear vision. Let’s look back for a bit as we plunge forward. FDA is a giant agency where a lot