●remember that FDA's guidance is generally based on knowledge of what most companies in the same field are doing and what FDA has required for other Sponsors' products. ●FDA can decide when the IND is filed and...
When a meeting is needed, a written request must be submitted to the FDA via the respectivecenter’s document room (paper submissions) or via the electronic gateway, as appropriate. Requests should be addressed to the appropriate review division ...
Cautionary Note Regarding Forward-Looking Statements This communication includes express or implied forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Act...
The double-buffered system also prevents time loss as the timekeeping countdown continues unabated by access to time register data. The DS1744 also contains its own power-fail circuitry that deselects the device when the VCC supply is in an out-of-tolerance condition. This feature prevents ...
14-Sunny Downstate(used to be my first preference as some of seniors did electives in gastro,endo&hemo there in early 2009 without toefl and step1 and when i saw it in 2009 fall,it said no IM rotations are offered there, but still u can get EM,Pediatrics,Derma,OB/GYN and ...
en-US word/phrase to avoid Preferred en-US word/phrase Achieve Do As well as Also, too Attempt Try Configure Set up Encounter Meet Execute Run Halt Stop Have an opportunity Can However But Give/provide guidance, give/provide information Help In addition Also In conjunction with With Locate ...
With vague references to exceptional indications (as mentioned in Dalbir Singh) offering little guidance, the standard to be satisfied for imposing such sentences seems to be very low – simply, not rarest of the rare. As a result, the hierarchical quantum of penalties based on severity of ...
the President should be deemed to have the power as part of the normal exercise of his constitutional rights. While it was true – Mr. Mutuma argued – that the People had delegated sovereign power to the President, it was important to note that what had been delegated wasexecutive, notlegi...
English example Indonesian example 1,526 $ 1,526.75 (+) 1.526 (+) $1.526,75 Colon Indonesian script is based on Latin alphabet; every rule for commas and other common punctuation marks is the same as in Latin script. The use of colon in Indonesian is to indicate an expansion of an ...
A subsequent request to schedule the meeting will be considered as a new request (i.e., a request that merits a new set of time frames as described in section III., Meeting Types). 如果会议请求被拒绝,FDA将根据表1...