View Cart  

Treatment INDs: Responding to Risks Created by Expanded Access

$337.00
September 2007
978-1-60004-144-0
81
View
Also Available:

Brought to you by FDAnews, get the management report that’s packed with detail-driven advice on how to protect yourself from the risks — while maximizing the rewards — created by the FDA’s newly proposed rules on experimental drugs, Treatment INDs: Responding to Risks Created by Expanded Access.

You’ll discover how to:

  • Understand how groups and individuals can gain access to your experimental drugs
    • The different pathways they can take under the new proposal
    • How, specifically, the FDA will grant that access
  • Know which charges you can — and can’t — levy for unapproved drugs
    • Along with the procedures you must undertake to determine eligibility
  • Limit your exposure to risk when you follow these strategies (especially important for drugmakers!) 
  • Follow the history of treatment INDs
    • Includes a research compliance attorney’s take on Abigail Alliance v. Eschenbach

Avoid legal issues with experimental drugs when you place your order for Treatment INDs: Responding to Risks Created by Expanded Access. Plus, you’ll get all the facts on adverse events.

After an Adverse Event: Who Will Face a Liability Claim?

Discover full details on adverse events, IRB approval and more, including:

  • Who faces liability claims after an adverse event
  • How manufacturers need to handle adverse event reports of treatment INDs
  • Why you need IRB approval, plus:
    • What information should be provided to the IRB
      • How and when you need to provide it
  • Plus much more

Don’t wait for a liability lawsuit — or the damaging bad press — that can result from adverse events caused by unapproved drugs. Find out where the FDA is headed in Treatment INDs: Responding to Risks Created by Expanded Access.

Buy Now!
Don’t wait — capitalize on the rich business opportunities presented by INDs today.

Treatment INDs: Responding to Risks Created by Expanded Access is priced at $337 each and is available in your choice of print or PDF format.

Interested in purchasing more than one print copy?
Significant volume discounts are available for ordering three or more copies of the same book. You must order them at the same time and provide a single payment to take advantage of the discount. Order below by clicking submit and then change your quantity in the shopping cart. The discount will be calculated automatically.

3-4 copies – 10%
5-6 copies – 15%
7-9 copies – 20%
10+ copies – 25%

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally with any questions.

Interested in Electronic Multi-user Access?
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the Electronic Books Library – a personalized collection of FDAnews publications that is fully searchable.

For more information please contact Customer Service:
Phone:  +1 (703) 538-7600 or toll free (888) 838-5578
Email:  customerservice@fdanews.com