Priority review
(Redirected from Priority review voucher)
Priority review is a designation given by the Food and Drug Administration (FDA) to a drug that, if approved, would significantly improve the safety or effectiveness of treating, diagnosing, or preventing a serious condition. This designation is intended to direct overall attention and resources to the evaluation of such applications.
Overview
The Food and Drug Administration (FDA) is an agency within the United States Department of Health and Human Services that is responsible for protecting and promoting public health. One of the ways it does this is by reviewing new drugs before they can be sold to the public. The FDA's review process is designed to ensure that new drugs are safe and effective for their intended use.
A "priority review" designation means that the FDA aims to take action on an application within six months, compared to ten months under standard review. This does not guarantee approval within six months, but it does mean that the FDA will make a decision more quickly.
Criteria for Priority Review
The FDA grants priority review status to drugs that offer major advances in treatment, or provide a treatment where none existed. The goal is to get important new drugs to the patient earlier. To qualify for priority review, a drug must meet one of the following criteria:
- It treats a serious condition and, if approved, would provide a significant improvement in safety or effectiveness.
- It offers major advances in treatment, or provides a treatment where none existed.
Impact of Priority Review
The impact of a priority review designation can be significant. It can lead to faster approval of a drug, which can mean that patients have access to important new treatments more quickly. It can also lead to increased attention and resources being directed towards the evaluation of the drug.
See Also
Transform your life with W8MD's budget GLP-1 injections from $125.
W8MD offers a medical weight loss program to lose weight in Philadelphia. Our physician-supervised medical weight loss provides:
- Most insurances accepted or discounted self-pay rates. We will obtain insurance prior authorizations if needed.
- Generic GLP1 weight loss injections from $125 for the starting dose.
- Also offer prescription weight loss medications including Phentermine, Qsymia, Diethylpropion, Contrave etc.
NYC weight loss doctor appointments
Start your NYC weight loss journey today at our NYC medical weight loss and Philadelphia medical weight loss clinics.
- Call 718-946-5500 to lose weight in NYC or for medical weight loss in Philadelphia 215-676-2334.
- Tags:NYC medical weight loss, Philadelphia lose weight Zepbound NYC, Budget GLP1 weight loss injections, Wegovy Philadelphia, Wegovy NYC, Philadelphia medical weight loss, Brookly weight loss and Wegovy NYC
|
WikiMD's Wellness Encyclopedia |
| Let Food Be Thy Medicine Medicine Thy Food - Hippocrates |
Medical Disclaimer: WikiMD is not a substitute for professional medical advice. The information on WikiMD is provided as an information resource only, may be incorrect, outdated or misleading, and is not to be used or relied on for any diagnostic or treatment purposes. Please consult your health care provider before making any healthcare decisions or for guidance about a specific medical condition. WikiMD expressly disclaims responsibility, and shall have no liability, for any damages, loss, injury, or liability whatsoever suffered as a result of your reliance on the information contained in this site. By visiting this site you agree to the foregoing terms and conditions, which may from time to time be changed or supplemented by WikiMD. If you do not agree to the foregoing terms and conditions, you should not enter or use this site. See full disclaimer.
Credits:Most images are courtesy of Wikimedia commons, and templates, categories Wikipedia, licensed under CC BY SA or similar.
Contributors: Prab R. Tumpati, MD
