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NDA leaders said the new programme demonstrated long-term commitment from the NDA on cyber security and it is looking to invest 80 million over the next 5 years in cyber safety.
While those who predicted a close contest missed the result by miles, others did not foresee the drubbing of the NDA or the landslide for the Grand Alliance.
The representatives from the US FDA reportedly reviewed the company's preliminary data package being prepared for the NDA submission, including clinical, non-clinical, regulatory and abuse liability elements.
According to Times Now ORG exit poll, the BJP-led NDA will get around 249 seats whereas the Congress-led UPA government might score around 148 seats.
If the pivotal trials prove efficacy (usually by meeting or exceeding a predefined statistical "p-value" for a primary efficacy endpoint) and safety, and none of the special trials requested by regulatory agencies uncovers any serious problems, then all data--pre-clinical and clinical--is compiled into an NDA for submission to regulatory agencies.
INEX has submitted two major sections of its "rolling" NDA to the FDA seeking marketing approval for Onco TCS as a treatment for relapsed aggressive NHL.
Its alliance with the northern exile opposition through the NDA and military support from neighboring Uganda, Eritrea, and (until recently) Ethiopia enhanced its strength in the mid-1990s.
Adobe Acrobat and PDF support online access to NDA submissions that simplifies distributing, locating, and archiving this huge volume of data," says Greg Brolund, associate director for technology and policy for the Center for Drug Evaluation and Research at the FDA.
Husker Harvest Days is a great opportunity for Nebraska farmers and ranchers to see what's new and innovative in the way of equipment, supplies and technology," said NDA Director Greg Ibach.
This is the company's second NDA for an Unapproved Marketed Drug (UMD).
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- ND virus
- ND Zelinsky Institute of Organic Chemistry
- Nd-YAG laser
- Nd:YAG laser
- Ndabaningi Sithole