approval letter

approval letter

An official communication from the FDA to inform a New Drug Application/Biologic License Application (NDA/BLA) applicant of its decision to allow commercial marketing of a drug product.
References in periodicals archive ?
Later, they called and said they needed a new initial approval letter with a different format, mentioning what interest rate NBAD is offering.
First of all, one should notice that the visa approval letter which is sent to his/her via email as an official permission to get on board and fly to Vietnam to get the visa stamped upon arrival at Vietnam airport is issued by the Vietnam Immigration Department, not the travel agent even though he/she works with it.
The approval letter allows clinical development of DP-VPA through Phase 3 for epilepsy
Hence Firm To Upload Approval Letter Of Rdso For The Tendered Item Along With Their Bid.
Note: In the interest of transparency and to help inform other states, the Department has posted here initial and approved flexibility requests, highlights of each state's plan, and peer review notes, as well as the agency's letter regarding peer review feedback and the Secretary's approval letter.
For showing proof of funds and or loan approval letter.
Linn Co-op was among the first five retailers to receive an EPA approval letter to sell the fuel.
The approval letter ofthe HUD designates the Total Artificial Heart for use in US patients "at risk of imminent death from nonreversible biventricular heart failure who are not eligible for cardiac transplant and have a body surface area (BSA) of >_1.
The 1996 approval letter estimated the time for completion at 3-4 years, depending on rate of enrollment.
When handling a short sale it is incumbent on all parties to carefully examine the approval letter and if the name on the letterhead doesn't match the lender of record in the title report to ask the servicer to provide the necessary additional documentation.
ROYAL APPROVAL Carlisle Racecourse managing director John Baker with Queen's seal of approval letter.
In addition, Astellas Pharma US has received an approval letter from the FDA for the agent as a treatment for hypervolemic hyponatremia.