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.