Sentences with phrase «subsequent decisions regarding»

From there on out, the system must rely on the data, structures (e.g., grade level data reviews, progress monitoring reviews) and the research to impact subsequent decisions regarding practices.

Not exact matches

These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine; clinical development activities may not be completed on time or at all; the results of our clinical development activities may not be positive, or predictive of real - world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.
Subsequent to a charter school applicant filing an appeal, the Commissioner of Education shall convene a meeting of the Charter School Appeal Commission (comprised of an equal number of members representing charter schools and school districts) to study and make recommendations to the State Board of Education regarding its pending decision about the appeal.
However, the courts in Oudin also did not have the benefit of this court's subsequent decision in Wood... Therefore, this court's endorsement in Oudin should not be viewed as supporting a broad, overarching principle regarding the motion judge's application of the severability provision in that case.»
Simplified, one could conclude that while the negative decision as regards the petition's admissibility is subject to full judicial review of the EU judge, any subsequent decision in regard of a positive petition can not be challenged before the EU courts, regardless of how the Parliament addresses the petition.
``... if it appears at the time the decision on pre-trial detention is taken that the «officer authorised by law to exercise judicial power» is liable to intervene in the subsequent proceedings as a representative of the prosecuting authority, then he could not be regarded as independent of the parties at that preliminary stage as it is possible for him to become one of the parties at a later stage.»
This aspect was not subsequently addressed in the High Court's ruling in the Wik case, and the first instance decision on mineral rights has since been judicially doubted because of subsequent High Court rulings about government «ownership» of resources: Justice North in the (minority of) the full Federal Court appeal decision in Ward - v - Western Australia observed of the Federal Court decision in Wik that «the conclusion that the mining legislation in Queensland conferred full beneficial ownership on the crown sufficient to extinguish native title can not be regarded as correct» (2000) 170 ALR 159 at para 843.
a b c d e f g h i j k l m n o p q r s t u v w x y z