To combat drug shortages in hospitals, the FDA issued a draft guidance that instructs manufacturers of prescription drug and biologic products as to how they should notify the FDA if a shortage is encountered or anticipated. Manufacturers are going to be required to provide detailed explanations as to why a shortage is anticipated. This naturally raises a whole host of potential legal pitfalls for the companies involved.
In this LIVE Webcast, some of the food and drug industry’s great minds share their sense of the best practices out there in addressing the problems. Topics to be discussed will address key concerns, including:
- - The FDA's identified issues that may lead to a shortage or disruption
- - When and How to Notify FDA and What Information Should be Reported
- - Products are Subject to Mandatory Notification
- - Specific Actions of FDA once information has been reported
- - What are the exceptions?
Course Level: Intermediate
Method Of Presentation: Group-Based-Internet
Developer: The Knowledge Group, LLC
Recommended CLE/CPE Hours: 1.75 - 2.0
Advance Preparation: Print and review course materials
Course Code: 124330
Course Fee: $199 - $249 (Early Bird Discounted Rate - on or before )
$299 - $349 (Regular Rate - registration after )
$149 (Government / Nonprofit Rate)
Agenda (coming soon)
**Information regarding the faculty panel will be posted shortly.
Please check back for updates.**
Who Should Attend?
- In-house Counsel for Food & Drug Manufactures
- FDA Attorneys
- Pharma Industry Lawyers
- General Counsel
- Senior Management
- Senior Executives
- Marketing/Sales Executive
- Legal Executive
- Operations Director
- Professionals coming from Pharmaceutical Firms
- Consultants & Clients in the Pharmaceutical Industries
- Drug Manufacturing Executives
This is a must attend event for drug manufacturers and professionals who would like to know more about the FDA's draft guidance, its purpose and importance.
- Guidance and best practices regarding reading & interpreting financial statements
- Hear directly from experienced practitioners & thought leaders
- Interact directly with panel during Q&A
Click the "Register" button below and be in the know! Significant discounts apply to those who register in advance!
** Discounts apply for early registration
Please note, the event date is firm although it may be subject to change. Please click here for details.
The Knowledge Group, LLC is producing this event for information purposes only. We do not intend to provide or offer business advice. The contents of this event are based upon the opinions of our speakers. The Knowledge Congress does not warrant their accuracy and completeness. The statements made by them are based on their independent opinions and does not necessarily reflect that of The Knowledge Congress' views. In no event shall The Knowledge Congress be liable to any person or business entity for any special, direct, indirect, punitive, incidental or consequential damages as a result of any information gathered from this webcast.
Understanding FDA’s Draft Guidance for Drug Shortage Notification
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Attention New York Attorneys:
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