#BLOOD STAR ORDER LICENSE#

The program applies to both drugs and biologics, collectively referred to as drug(s). STAR is available for certain supplemental new drug applications (sNDAs) and supplemental biologics license applications (sBLAs) that propose new uses of approved therapies to address an unmet medical need. The PDUFA review clock will start once the agency receives the Part 2 Submission, which will include the final clinical study report(s), the Integrated Summary of Safety, and Integrated Summary of Effectiveness. Accepted STAR applications will be submitted in a “split” fashion, specifically in two parts with the components submitted approximately two months apart.įDA will begin to review the data once the agency receives the complete Part 1 Submission. The STAR pilot program will apply to efficacy supplements across all therapeutic areas and review disciplines that meet specific criteria. OverviewįDA is establishing a STAR pilot program, which aims to shorten the time from the date of complete submission to the action date, in order to allow earlier patient access to therapies that address an unmet medical need. You are responsible for any customs fees incurred after I ship the item, as I have no way of knowing what or when the fees will be charged.Under the Prescription Drug User Fee Act (PDUFA) VII Commitment Letter, FDA is creating the Split Real Time Application Review (STAR) pilot program. Then it may require additional time depending how long it takes at customs - I have no way of knowing how long this will be. This can take 10-14 days or more to get to your country's customs. I will ship First Class International via the US Postal Service. Shipping rates are listed on the Shipping tab on each listing. The estimated delivery date is NOT guaranteed, but it is usually accurate. This service takes 1-3 business days, and a tracking number is included. The estimated delivery date is NOT guaranteed, but it is usually accurate.įor items $100 or over, INSURANCE IS INCLUDED in the shipping fee, and ship USPS First Class in a padded envelope or a cardboard box with packing material to protect your purchase.

~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~Īll items under $100 ship USPS First Class in a padded envelope or a cardboard box with packing material to protect your purchase. (*I ship USPS First Class and Priority - the estimated delivery date is NOT guaranteed, but it is usually accurate.) ★★★ You will receive an Etsy Shipping Notification email with the tracking number when your item(s) ship. ★★★ Please allow up to 14 days production time for personalized and made to order items. ★★★ (*I ship USPS First Class and Priority - the estimated delivery date is NOT guaranteed, but it is usually accurate.) You will receive an Etsy Shipping Notification email with the tracking number when your item(s) ship. ★★★ Ready to ship items will be mailed within 1-3 days. I aim to produce quality work, and I want you to be satisfied with your purchase. Please message me with the issue, and together we will determine the best course of action. REPAIRS: Broken or damaged pieces will be dealt with on a case by case basis. Once I receive the item, I will refund the purchase price (minus the original shipping fee) to the account/email address that it was originally purchased with, or send the exchange item. Item must be returned in original condition, in original packaging, within 1 week. NON-PERSONALIZED ITEMS: If within 3 days from receipt of your non-personalized item you decide you would like to make a return or exchange, please contact me to let me know. I will refund the return shipping cost, and I will create a new piece and mail it back to you ASAP.) I will let you know if I need you to mail it back to me or not. However, if I have misspelled something, contact me within 1 week of receipt of your item to let me know. PERSONALIZED ITEMS: Custom and/or personalized items may NOT be returned.

Blood star order