USFDA releases guidance on Dear Doctor letters

The US Food and Drug Administration (FDA) has presented a final guidance aiming to clarify the need for information given in the Dear Doctor or Dear Healthcare Provider (DHCP) letters. These letters are bulk mailers and are usually sent out to inform about an adverse reaction or a problem with the usage of a drug or medicinal product.

Such letters are also useful in providing the healthcare providers with additional updated information about the use of the drug or medicinal product. As these letters are actually sent by email, the letter related FDA notes on the website of the manufacturer are also made available to the healthcare provider. However, certain problems like when to send the letter, which information should be sent and how it should be organized to present it in the letter, needs attention.

As such details were not covered so far, it is important to have this new guidance that can help to improve doctor communication and cover up the gap and between the given regulations and the manufacturers best practices. The new guidance suggests that manufacturers should work with the concerned FDA department and conclude about the matter and the format to be presented in the letters. VIEW full guidance