Glossary Building Post – 5

These final terms come from the Pharma Slides.

The first term is NDA. NDA stands for New Drug Application. Even after reading what the acronym stood for, I still had no idea what this meant. According to the FDA page on NDA’s, this stands for

The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S.

The goals of the NDA are to provide the drug reviewer with information to assess the drug in safety, benefits vs. risks, if the labeling is appropriate and whether the manufacturing methods preserve the drug’s identity, strength, quality and purity (Center for Drug Evaluation and Research). I believe that this term is important for consumers because in a way, it makes sure that companies advise and report everything about the given drug from clinical trials to ingredients and safety to packaging. Without this information, the FDA cannot approve a new drug and this is what keeps consumers safe and large companies from selling just about anything.

The next term is product claim. This is one of three drug advertisement methods. Product claim advertisements are very straightforward. They name a drug and explain which conditions/diseases the drug can treat. Reminder ads only give a drug’s name but not the use and help-seeking ads discuss a disease/condition but doesn’t make any recommendations on which drugs to take to help with treatment.

I think it’s important that all consumers know all of these drug advertisement methods. While they all serve different purposes, essentially, they all get consumers thinking “Do I have that?” “Do I need that?” “I should ask my doctor what is typically used to treat ____.” “I wonder what that drug is used for?”

  • New Drug Application: The vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S.
  • Product Claim Ad: Names a drug and explains the conditions it treats.
  • Reminder Ad: Only gives drug’s name but not use.
  • Help-Seeking Ad: Explains a disease/condition but doesn’t make any recommendations on which drugs to take.

 

Sources

Center for Drug Evaluation and Research. (n.d.). New Drug Application (NDA). Retrieved

November 21, 2017, from

https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm

Center for Drug Evaluation and Research. (n.d.). Prescription Drug Advertising – Sample

Prescription Drug Advertisements. Retrieved November 21, 2017, from

https://www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/ucm168421.htm

Pharma Slides

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