FDA Update: Responding to Unsolicited Requests for Off-Label Information

Event Information
Product Format
Prerecorded Event
90 Minutes
Product Description

Insights On FDA Guidance About Off-Label Information Management

Many FDA approved products have uses beyond what they have been approved for. Manufacturers have to follow very strict guidelines to inform physicians about these additional uses. Manufacturers also have to deal with consumers directly asking for more information about such uses. In this 90 minutes session, Dr. Mukesh Kumar will discuss the limitations and regulations for discussing, collecting, distributing and managing off-label information about FDA-approved products.

Recent FDA guidelines regarding role of manufacturers in handling unsolicited requests for off-label information will be discussed with practical advice based on multiple case studies. Attendees will get a list of dos and don’ts for discussing published material – both peer-reviewed articles and books, clinical experience, investigational uses, and anecdotal information. Dr. Kumar will also discuss the social media techniques.

A common myth is that FDA bans all off-label uses of drugs, medical devices and biologics. On the contrary FDA acknowledges that the unapproved uses may be beneficial to some patients and physicians should be allowed to prescribe FDA regulated products for any off-label use they may seem fit. However, there are strict controls on manufacturers using off-label information to market their products. This session will discuss the regulatory thoughts and practical tips on off-label promotion for the manufacturers. This will also be useful for physicians and patients to understand which information is credible and which illegal.

Topics covered in the session:

  • FDA-rules for handling unsolicited questions about Off-label information
  • FDA guidance about off-label information management
  • Pros and cons of common methods for off-label promotion
  • Converting off-label to on-label information
  • Do’s and don’ts of social media techniques in off-label promotion

Who should attend

  • Manufacturers of FDA regulated products: Drug, Medical Device and Biotech Companies, Dietary supplement manufacturers
  • Marketing and Advertising Professionals
  • Financial analysts and investors, venture capitalists, insurance professionals
  • Legal experts involved in advising manufacturers of marketed products
  • Senior management for companies developing new products for US market
  • Regulatory affairs professionals, research analysts

Order Below or Call 1-866-458-2965 Today

Order Form

(Select the format below)

Choose Quantity:

(*) Single User Price

You can also order through:




About Our Speaker

Dr. Mukesh Kumar - Pharma Regulation Expert

Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials, and multi-national project management for medicinal and diagnostic products. He has been involved in about 100...   More Info
More Events By The Speaker

Why AudioEducator?
  • Save money on travel.
  • Meet your specific training needs.
  • Keep learning after the event.
  • Save time training your whole staff.
Join Our Mailing List
Our Accreditation Partners
Facebook Twitter Linkedin Youtube RSS Feeds Google Plus