Sentences with phrase «regarded by the regulatory authorities»

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.

The fact is many of these worry needlessly as Valutrades is a well managed brokerage firm regulated by the UK's Financial Conduct Authority, a well regarded financial regulatory body.

Despite facing some serious allegations by regulatory authorities around the world regarding the gambling nature of loot boxes, EA disagree and will continue to utilize them.

Our lawyers have acted for architects, engineers, lawyers, dentists, and accountants in professional errors and omissions claims, advised clients before professional regulatory bodies, acted for professional administrative bodies, provided advice regarding investigations conducted by administrative authorities, and have acted in judicial reviews of decisions made by professional regulatory bodies.

In late 2014 (and as reported on this blog), the Canadian Securities Administrators (CSA) published «comply or explain» rules (the CSA Rules) regarding the representation of women in director and executive officer positions that were adopted by the securities regulatory authorities in a majority of Canadian provinces and territories.

Special Achievements • Conceived and implemented a unique weekly risk analysis mechanism that reduced accident rate by 10 % • Trained 25 employees regarding implementation of OSHA regulatory authority guidelines • Led the company in achieving monthly OH&S targets consistently via ensuring implementation of best employee safety practices