About FDA
-
-
Why do some drug labels get changed so often ?
Drug labels are changed frequently so that they contain the most up-to-date information about the drug. After an approved drug is marketed and used by many more people than those originally tested, new information often emerges about the product, for example
- new side effects
- new ways of dosing
- new uses for the drug
This new information is added by the manufacturer to the drug’s label so consumers and health care professionals have all the information necessary for safe and effective use of the drug.
All changes to a drug’s label must be approved by FDA. The manufacturer sends proposed changes to FDA that FDA reviews, revises if necessary, and approves. After approval, the manufacturer prints a new label.
Show all related FDA Basics Questions
- Where can I find information about adverse reactions to a medicine prescribed for my child?
- Where can I find information about medicines prescribed for my child?
- Materials from Webinar on Access to Investigational Drugs
- FDA Basics Webinar: "Mini-Sentinel," FDA's New Tool for Monitoring the Safety of FDA-Approved Medical Products
- How FDA Evaluates Regulated Products: Drugs
- FDA Webinar on Prescription Drug Shortages
- FDA Webinar on "Bad Ads" Program
- FDA Basics Webinar on Generic Drugs
- FDA Basics Videos: Tim Coté on Orphan Drugs
- What is an FDA Drug Safety Communication?
- What is counterfeit medicine?
- FDA Basic Video: Interview with John Jenkins on New Drugs (Video)
- What are unapproved drugs and why are they on the market?
- How can I stay better informed about drugs? Is there a reliable website FDA recommends?
- How do I discard medicine that I no longer need, do I just throw it in the garbage?
- How do I report a bad reaction to medicine or medication error to FDA?
- Does FDA approve the proprietary names of prescription drugs?
- What does FDA require drug manufacturers to do to prevent contaminated drugs? If contamination occurs, how must they correct the problem?
- How does FDA help consumers when drug shortages happen?
- Does FDA approve the information given out by pharmacies when I pick up my medicine?
- How does FDA decide when a drug is not safe enough to stay on the market?
- How do I find out if a drug is approved? Is there a Web site I can go to?
- What is the approval process for a new prescription drug?
- What is a Warning Letter?
- Can FDA ban direct-to-consumer drug advertising?
-
How helpful was this information?
-
?
-
-
