This article is more than 5 years old. Information may no longer be current.

FDA to implement generic drug rule Aug. 18

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

The Food and Drug Administration will soon implement a rule designed to help speed the approval of generic drugs to market. The rule, to be implemented Aug. 18, will limit the number of automatic 30-month stays that have delayed generic drug availability in the past, according to an FDA news release.

The final rule clarifies the types of drugs that can be submitted for inclusion in the FDA’s sourcebook. The rule is designed to prevent companies from submitting new patent claims to extend marketing protection for a drug if these new claims are unlikely to bring real innovation, according to the release.

The FDA has determined it will allow only submissions of new patents that affect the drug substance, the formulation and composition of the drug or its method of use, according to the release.