Author Archives: Mark Senak

New Approvals in 2022

We are at mid-year, a good time to check in and see how we are doing on a number of fronts – including where we are with new drug approvals. Over the years, Congress has acted to enhance the ability … Continue reading

Posted in Uncategorized | Comments Off on New Approvals in 2022

Enforcement Update: OPDP Issues Untitled Letter

We are four months into the year, and this week OPDP has issued its fourth regulatory action letter of 2022. Two of the previous were Warning Letters, considered the more serious of the two categories, and two, including the latest, … Continue reading

Posted in Warning Letters | Tagged | Comments Off on Enforcement Update: OPDP Issues Untitled Letter

New Landscape for the Old Pandemic

Tectonic pandemic plates are shifting respecting the COVID-19 pandemic. For weeks now we have been watching caseloads in the United States broadly fall. It feels as if we are indeed shifting gears. There are other moving parts that are in … Continue reading

Posted in COVID19, Current Affairs | Tagged | Comments Off on New Landscape for the Old Pandemic

Are We Moving On From Covid?

Mask mandates are dropping like flies. Restrictions are being lowered. In my observation, it feels that they are going to the wayside not only because of dropping caseloads, but also because people are just more than ready to move on. … Continue reading

Posted in FDA Image, FDA Policy | Tagged | Comments Off on Are We Moving On From Covid?

OPDP Issues First Regulatory Action Letter of 2022

FDA’s Office of Prescription Drug Promotion (OPDP) issued the first regulatory action letter for 2022. This one has some notable characteristics. As has been frequently noted, enforcement actions by OPDP have diminished considerably over the years. Another characteristic of recent … Continue reading

Posted in Warning Letters | Tagged , , , | Comments Off on OPDP Issues First Regulatory Action Letter of 2022