As a manager responsible for planning, executing, or reacting to a new drug approval, you are on the front lines, in perhaps the most visible position in your company. Make sure you have all of the information you need to make the best possible decisions.
Understanding how and why FDA takes certain actions on first NDAs/BLAs for novel therapeutic drugs is unquestionably a must-have component of key pre-submission knowledge for any manager that assists with the development or marketing for novel therapeutic drugs. Think about it. FDA actions on marketing applications are important to nearly everyone involved with drug development and marketing. Consider these universal mid- and senior-level management responsibilities in pharma and biotech:
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Regulatory managers are responsible for minimizing regulatory risk by navigating smoothly through FDA's people and processes and informing others where potential pitfalls might lie.
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Project and portfolio managers must plan for resource needs that depend on reliable estimates of key regulatory and development milestones.
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Market strategists rely on best estimates of approval and launch times to gauge the future value of products.
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Brand managers must recruit, train and deploy sales staff to coincide as closely as possible with launch.
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CFOs and investor relations personnel must manage external expectations...
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And so on.
In FDA's Approvable and Related NDA/BLA Actions, an exclusive PGS report, you will find authoritative information written by an experienced industry consultant that will help you meet your responsibilities:
- Listings of all products that received an "approvable" decision prior to marketing approval between 1998 and 2005 with key regulatory data;
- Additional detailed listings for therapeutic NMEs and therapeutic recombinant proteins for over 100 products that met above criteria (about 1,500 data points);
- Statistics and descriptions summarizing above data including overall effects of approvable actions on approval timing; "survival" analyses of NME-NDAs, exploration of factors predicting NDA approval delay; issues cited as reasons for approvable decisions and their relative importance, including recent trends;
- Actionable implications of key findings for managers;
- Definitions and descriptions, with links to additional information, of all possible FDA NDA/BLA actions and regulations that govern these actions;
- Prototypical recent Action Letters from CDER and CBER (with some others available upon request);
- A listing of 100 additional therapeutic drug products whose NME-NDAs were approved by CDER without an intervening approvable action;
- And more useful information; see below for the full Table of Contents.
We stand behind our work and want to make sure you get what you need from this report. We will support your efforts by providing you with access to the report's author, Dr. Fredric Cohen, to answer your questions that are directly related to the report. We'll even provide you with additional primary data (depending on availiability) that support information summarized in the report.
Publication date: April 2006
Publisher: Pharma Growth Strategies LLC
Pages: 125
Price, single PDF license: only $895 NOW FREE!
Click on cover image below to view a complete Table of Contents
Pharma Growth Strategies LLC is not affiliated with the U.S. Food and Drug Administration
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