Global Regulatory Intelligence
Log in |  Register

Login to your account

Username *
Password *
Remember Me

Create an account

Registering to our Regulatory Updates easy andis should only
take few minutes. To begin, enter your email enter your email
address below so we can check to see if it is already existing
in our records. Your email address will also be used as your
user name when you log in.

Fields marked with an asterisk (*) are required.
Name *
Username *
Password *
Verify password *
Email *
Verify email *
Captcha *
Reload Captcha

USA: FDA Releases Finalised Guidance on Promotional Labelling and Advertisements for Medicines

Tuesday, December 12, 2017: Draft guidance from 2013 has been finalised by the US Food and Drug Administration (FDA) which clarifies the requirements for product name placement, size, prominence, and frequency in promotional labelling and advertisements for human prescription drugs. To ensure safe and effective use of a medicine, the disclosure of the product name in promotional labelling and advertisements is important for identification.

In addition to a title change and editorial changes for clarification, the guidance has been updated to clarify particular concepts discussed in the revised draft guidance and gives examples illustrating prominence issues.

Further issues that are clarified in the guidance by the FDA concern the direct conjunction of the proprietary and established names, including the frequency of use of the established name on printed pages or spreads, in running text or columns, in the audio proportion of audio-visual promotions and in electronic media.

The recommendations apply to product names in print media promotional labelling and advertisements, broadcast advertisements, electronic and computer-based promotions and audio-visual promotional labelling.

More Details
© 2016 MakroCare. All Rights Reserved.
  Privacy policy