About the Author
My name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in New York. For the past several years, I have been consulting with pharmaceutical and biologic companies that are engaged in the process of bringing new drugs to market. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.
Tag Archives: #FDA
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 #FDA, #OPDP, #Untitled Letter, #Warning Letter
Comments Off on OPDP Issues First Regulatory Action Letter of 2022
What They Said 2021 – An Overview of FDA Press Statements
Each year we look back to take stock of how the agency has been communicating in the course of the previous year and assess how that might compare to years gone by. In fact from year to year, there is … Continue reading
Posted in FDA Image, FDA Policy
Tagged #FDA, #FDACommunications, #FDAPressReleases
Comments Off on What They Said 2021 – An Overview of FDA Press Statements
FDA OPDP Look Back at 2021 – The Yawning Gap
Once again it was a quiet year with respect to the FDA’s Office of Prescription Drug Programs (OPDP). As noted in the past, there are two primary means for understanding the agency’s latest thinking with respect to promotional communications from … Continue reading
Posted in DTC Advertising, FDA, FDA Policy
Tagged #FDA, #OPDP, #pharma
Comments Off on FDA OPDP Look Back at 2021 – The Yawning Gap
FDA Authorizes Third Dose – Some Implications
What does “fully vaccinated” mean today? In the face of the widening spread of the SARS-Cov-2 variant, the rise in breakthrough cases, and data that suggests a slight waning effect over time of vaccines, FDA acted yesterday to protect some … Continue reading
Posted in Uncategorized
Tagged #COVID19; #coronavirus, #FDA
Comments Off on FDA Authorizes Third Dose – Some Implications
What They Said – FDA Press Releases Mid-2021
It has been a regular feature of the blog to give a read on what FDA has been talking about, at least through the form of press releases. It is not always an easy task because the nature of FDA’s … Continue reading