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.
Category Archives: FDA Policy
FDA Takes A Number of Actions to Enhance the Market for Biosimilars – A Process Not an Event
There is a policy interest in driving the biosimilar market. Among other reasons, increasing the number of generic drugs and biosimilars on the market addresses another policy priority – having an impact on the high cost of medicine. The approval … Continue reading
Posted in Biologics, FDA Policy
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2020 Vision – Notable FDA Actions During 2019
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 happens. Narrowing down the actions of significance is therefore a … Continue reading
Posted in FDA Image, FDA Policy
Tagged FDA 2019, FDA Approvals, FDA CBD, FDA Enforcement
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CBD and FDA – Where Are We?
Last week FDA and FTC jointly issued a warning letter to a seller of CBD products in Florida – the seventh such warning letter of the year. The letter took issue with the manufactuer’s marketing practices related to multiple products … Continue reading
Posted in CBD, FDA Policy
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FDA Sends CBD Related Warning Letter
This week FDA sent a Warning Letter to a company engaged in marketing products containing cannabidiol (CBD) to consumers for a wide variety of uses in both humans and canines. In addition to the letter, the agency underscored their action … Continue reading
Posted in CBD, FDA Policy, Warning Letters
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New Drug Approvals – A Mid-Year Assessment
During the past few years, there has been a renewed focus on facilitating the development of new medicines by providing new mechanisms to streamline the review process and get drugs to patients more quickly. The passage of the 21st Century … Continue reading
Posted in FDA, FDA Policy
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