- GAO Issues Review of FDA on Safety – Unless you had been living under a rock, you would have taken note that the week began with a critical review of the FDA and its ability to consistently and effectively respond to emerging safety issues when the General Accounting Office report issued on Monday, April 24. Essentially the GAO states that the FDA could be more vigilent on matters of post-marketing safety and should be supplied with the necessary tools to get the job done. It is, I suppose, a matter of future debate as to how that would be paid for.
- Changes Made to this Blog – I added two resources to the right that offer a glossary of terms in connection with clinical trials. They are really good and you can find them under the heading Good Learning Tools.
- Generic Pravachol – As statins neared the end of their patent life, there were two failed attempts to get them to move from RX to OTC. Now the first generic has been approved by the FDA.
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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