Daily Archives: October 11, 2006

Tracking Approvable Letters

Posted on October 11, 2006 by Mark Senak

There are three general outcomes from submitting a new drug to the FDA for approval. First – approval, for which everyone hopes. Second non-approval, which is the obvious bad scenario. Third are approvable letters, issued by the FDA when they … Continue reading →

Posted in Regulatory Communications | Comments Off

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.
Stay Connected
- Subscribe via Email
- Contact Me
- Twitter
- RSS
My Profile

I 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 Washington, D.C. 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.
Posts by Date
October 2006

M T W T F S S

1

2 3 4 5 6 7 8

9 10 11 12 13 14 15

16 17 18 19 20 21 22

23 24 25 26 27 28 29

30 31

« Sep Nov »
My Favorite Dogs
Twitter List
Legislative Tracking Tools

Daily Archives: October 11, 2006

Tracking Approvable Letters

About the Author

Stay Connected

My Profile

About This Blog

Posts by Date

My Favorite Dogs

Twitter List

Legislative Tracking Tools

RSS

Books by Me