The FDA finalized guidelines Sept. 18 for submitting petitions against new drug applications in an effort to prevent drug companies from slowing down the approval process of a rival drug.
The guidance will help the FDA determine whether citizen petitions and petitions for a stay of agency action are being submitted because a drugmaker wants to slow the approval process of a pending generic or biosimilar, according to Regulatory Focus.
The new guidelines come after the FDA expressed concerns to Congress that petitions are often submitted by competing drug companies and do not raise valid concerns.
The guidelines outline which issues are of valid concern and impose a 150-day deadline to take action on petitions.
The FDA also said it will refer certain issues to the Federal Trade Commission to dissuade drugmakers from improperly using these petitions.
Read the full report here.