Information About Off-Label Uses of Drugs

Certain conditions exist that may allow the distribution of information related to off-label use of drugs. For drug approval; The Food and Drug Administration Modernization Act (FDAMA section 401) must contain information for a drug or device that has been approved by the FDA. 

However, according to the new 2009 guidance, drug-approval status is not mentioned. For the filing of a complementary new drug application, FDAMA requires that the manufacturer submit a supplemental new drug application for a new experiment or study. You can find the best fda drug label from various sources.

fda drug label

In the new guidance, nothing is mentioned, but companies are encouraged to seek approval for new uses or indications. In advance provision to the FDA, the company must present all information related to the drug's efficacy and safety 60 days prior to dissemination. 

In the new guidance, it is not mentioned. As for the source of the underlying clinical data, it must be accurate as a result of serious well-controlled clinical studies and trials according to FDAMA and the new 2009 guidance. 

Regarding the subject of accuracy, FDAMA requires that information must be accurate, truthful, not misleading, conclusions should be appropriate and that information should not be a threat to public safety. 

Required disclosures must state that off-label use is not FDA-approved and they must identify other FDA-approved products for the same use.