FDA Medication Guide

 FDA Medication Information

Medication Guides are paper handouts that come with many prescription medicines.

The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.
FDA requires that Medication Guides be issued with certain prescribed drugs and biological products when the Agency determines that:

• certain information is necessary to prevent serious adverse effects
• patient decision-making should be informed by information about a known serious side effect with a product, or
• patient adherence to directions for the use of a product are essential to its effectiveness.
  

Opdivo (nivolumab) [3/2015 version]
Belsomra  (suvorexant) [2014 version]
Lynparza (olaparib) [2014 version]

Learn more from FDA here >> 

Global Compliance Seminar (GCS) provides global and FDA regulatory consulting and training services to the FDA-regulated industry in collaboration with the Regulatory Doctor. The US FDA is an Agency under the US Department of Health and Human Services (DHHS).

Other Information

• FDA Warns Consumer Not to Rely on Asthma Products Labeled as Homeopathic 
• Guidance for Nutrition Labeling of Standard Menu Items in Restaurants 
• Breastfeeding Linked to Higher IQ