Webinars >>FDA Regulations
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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:
Who will benefit:
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For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com
