FDA MAP
  • Home
  • Training
    • WORKSHOPS
    • WEBINARS
    • CUSTOM TRAINING
  • SERVICES
    • REGULATORY SERVICES
    • FDA AUDITING
    • QUALITY ASSURANCE
    • CLINICAL TRIAL SERVICES
  • News Releases
  • About Us
Webinars >>FDA Regulations
FDA’s Requirements for a Dear Doctor Letter

Dear Doctor letters are an important and required document to alert health care professionals to previously unknown adverse reactions linked to a drug, changes in dosage that could improve a drug's effectiveness and other important information. It is not just a letter mailed to the doctors but a process that assures that important information regarding a prescription product is appropriately distributed. FDA expects manufacturers to track who actually read their letter and to evaluate the impact of the Dear Doctor letter on the physician’s prescribing habits. Timely creation and distribution of Dear Doctor letters not only is essential for the branded drugs but can be used in product liability litigations against generic drugs as well. All manufactures of prescription drug and biologics products must comply with the regulatory requirements for Dear Doctor letters.
Why should you attend:
​

This webinar, presented by a leading regulatory affairs expert, discusses FDA requirements and expectations for Dear Doctor letters, also known as Dear Health Care Provider (DHCP) letters. The webinar will discuss when and how such letters should be created, how should they be distributed, and how should their impact be evaluated. The session will highlight key regulatory requirements, dos and don’ts, common areas of concern, and trouble-shooting Dear Doctor letters using case studies and examples from the presenter’s vast experience helping companies big and small in complying with FDA requirements. FDA’s current guidance documents and best practices will be discussed along with success and challenge factors. The training is designed to provide a well-rounded training to all stakeholders in all aspects of the Dear Doctor letters.
Areas Covered in the Session:
  • When to use Dear Doctor letters
  • FDA required format, style, and organization of the DHCP letter
  • FDA consultations for DHCP letter content and distribution
  • Assessing the impact of the Dear Doctor letter
  • Managing public information related to the Dear Doctor letter
  • Common errors and potential solutions
Who will benefit:
  • Regulatory affairs personnel
  • Safety reporting personnel
  • Quality assurance personnel
  • Pharmacovigilance professionals
  • People interested in investing in the FDA-regulated industry
Date: May 29, 2020
​Duration: 60 Minutes
​
Time: 12 PM EST
Register Online

Speaker: Mukesh Kumar
​
PhD, RAC | Brij Strategic Consultations, 
 USA
​

Picture

    For more info, fill the box below. We will contact you within 24 hrs.

Submit
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com

Our Services

  • Workshops
  • Webinars
  • On-Demand Webinars
  • Custom training
  • Training Subscriptions
  • Corporate Registration
  • Certification Program
  • Smart Recruitment
  • Corporate Registration - Online Workshop​

Company

  • About Us​
  • Testimonials
  • Free Resources
  • Newsletter
  • Videos (Free Tutorials)

Support

  • Contact Us
  • Terms of Service
  • Privacy Policy
  • News Archive
Consultation Service
FDA Training Company
Copyright © 2022 FDAMap.com
Use of this Web site constitutes acceptance of the FDAMap Terms of Use and Privacy Policy.