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2. Rimegepant - Wikipedia

   en.wikipedia.org/wiki/Rimegepant

   Rimegepant, sold under the brand name Nurtec ODT among others, is a medication used for the acute treatment of migraine with or without aura in adults and the prophylactic/ preventive treatment of episodic migraine in adults.

3. Priority review - Wikipedia

   en.wikipedia.org/wiki/Priority_review

   The pediatric voucher program includes changes to the voucher program. First, the pediatric treatment developer can ask the FDA in advance for an indication of whether the disease qualifies as a rare, pediatric disease. [citation needed] The awardee must market the drug within 365 days of approval, or the voucher may be revoked.

4. Fast track (FDA) - Wikipedia

   en.wikipedia.org/wiki/Fast_track_(FDA)

   Accelerated approval is meant for drugs that demonstrate an effect on a surrogate, or intermediate endpoint reasonably likely to predict clinical benefit. Priority review shortens the FDA review process for a new drug from ten months to six months, and is appropriate for drugs that demonstrate significant improvements in both safety and ...

5. New Drug Application - Wikipedia

   en.wikipedia.org/wiki/New_Drug_Application

   The results of the testing program are codified in an FDA-approved public document that is called the product label, package insert or Full Prescribing Information. [10] The prescribing information is widely available on the web from the FDA, [11] drug manufacturers, and frequently inserted into drug packages. The main purpose of a drug label ...

6. System Mechanic Software | 30-Day Free* Trial | AOL Products

   www.aol.com/products/utilities/system-mechanic

   Download System Mechanic to help repair and speed up your slow PC. Try it free* for 30 days now.

7. Expanded access - Wikipedia

   en.wikipedia.org/wiki/Expanded_access

   Expanded access or compassionate use is the use of an unapproved drug or medical device under special forms of investigational new drug applications (IND) or IDE application for devices, outside of a clinical trial, by people with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress ...

8. List of clinical trial registries - Wikipedia

   en.wikipedia.org/wiki/List_of_clinical_trial...

   The DRKS is an open access, free of charge online register for clinical trials and is available both in English and German. DRKS is part of the WHO's ICTRP. The DRKS works with two partner registries in Germany, DeReG (German Registry for Somatic Gene-Transfer Trials) and Clinical Trial Registry of the University Medical Center Freiburg. [4]

9. Pfizer (PFE) Q3 2024 Earnings Call Transcript - AOL

   www.aol.com/pfizer-pfe-q3-2024-earnings...

   A Phase III trial is underway, and pending positive data and regulatory approval, VLA15 would become the only vaccine available to help prevent the acute severe and long-term health consequences ...