●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...
1)Formal Meeting – for purposes of Standard Operating Policy and Procedure (SOPP) , formal meeting includes any meeting requested by a sponsor or applicant (requester) following the procedures provided in this SOPP and the appropriate guidance docum...
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...
Other parametric values quoted in this data sheet are provided for guidance. Maxim Integrated 160 Rio Robles, San Jose, CA 95134 USA 1-408-601-1000 © 2013 Maxim Integrated Products, Inc. Maxim Integrated and the Maxim Integrated logo are trademarks of Maxim Integrated Products, Inc. 下载...
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 ...
It is not possible to determine what guidance the IRS and Treasury will ultimately issue, if any. Any such future guidance may affect the amount, timing and character of income, gain, or loss in respect of the Notes, possibly with retroactive effect. The IRS and ...
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 ...
en-US word/phrase to avoid Achieve As well as Attempt Configure Encounter Execute Preferred en-US word/phrase Do Also, too Try Set up Meet Run Microsoft Konkani Style Guide Page 7 of 51 Halt Have an opportunity However Give/provide guidance, give/provide information In addition In conjunction...
FDA can decide when the IND is filed and, when more data are available, that the guidance they initially provided at the pre-IND meeting is no longer valid. Pre-IND briefing documents should, therefore, be well-writt...