- 2021 – In 2021, FDA’s OPDP has issued a total for 4 regulatory action letters
- 7.14.2021 – Amgen – UNTITLED LETTER – for Banner Ad related to Neulasta – unsupported claim
- 3.8.2021 – Biohaven Pharmaceuticals – UNTITLED LETTER – for DTC Video related to NURTEC – risk minimization, superiority claim, unsubstantiated claim
- 2.23.2021 – CooperSurgical Inc – WARNING LETTER – for DTC Video related to ParaGard for risk minimization
- 2.11.2021 – AcelRx Pharmaceuticals – WARNING LETTER – for a display ad and a banner ad related to Dsuvia for risk minimization
About the AuthorMy 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.
My ProfileI am an authority on regulatory aspects of communications and medical products, with particular emphasis on pre-approval communications; strategist to help pharma and biotech companies prepare best case for advisory committee approval; and counselor in issues and crisis management. I am a frequent speaker on various aspects of same - drug development, promotion, reimbursement and new media in a highly regulated environment. Author of books, newspaper and magazine pieces related to drug marketing and promotion as well as HIV specialty pieces. And of course... blogger!
About This Blog
Eye on FDA is published by Mark Senak of FleishmanHillard’s New York office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of FleishmanHillard or its clients.
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