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 ?
Mr Ng'ang'a was later summoned by the detectives after which the county criminal investigations officer told the Nation that the Muwasco MD had maintained that the letter had been taken to the CEC for approval.He said the CEC claimed he had been alerted by Wasreb of the "fake letter" when they called him to confirm whether the approval letter originated from his office.
Ali Darawesh, the executive manager of the Cairo International stadium, stated in the approval letter that timings and scheduling for the matches will be decided after the summer as the stadium will be going through refurbishment.
While the application and approval letter do not specify Kornit Digital (KRNT) printers, Drab is "highly confident" the printers to be installed in the facility will be supplied by Kornit.
Parti Pribumi Bersatu Malaysia (Bersatu) president Tan Sri Muhyiddin Yassin today handed over the approval letter from the Registrar of Societies (RoS) to the party's Sabah coordinator Datuk Hajiji Noor to establish new divisions in the state.
The St Kitts-Nevis-based citizenship firm to whom the letter was addressed, earlier told Gulf News that "it was not involved in any way" with the altering of the government-issued approval letter.
The 2014 approval letter required the vaccine's manufacturer, Pfizer, to assess the efficacy and safety of Trumenba among children aged 1-9 years.
The apex court sought approval letter and documents of Imran Khan from CDA and concerned Union Council.
On 2 February 2018, the TPEx granted approval via Approval Letter No: 10700029171.
It said, "With the receipt of LoA and after six months preparation for fulfilling the requirements as specified in the conditional approval letter issued by the ministry, MPay Group is now able to start the money lending business targeting both individuals and businesses, over and above its Quickash Peer-to-Peer financing platform."
MNA Khayal Zaman Orakzai and Senator Aurangzeb Khan told media the meeting with federal minister was successful and federal government approved Rs.400 million for the pipeline of gas project to Hangu district and showed the approval letter to the delegation of elected members of the area.
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.
(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.)