Sentences with phrase «regulatory safety approvals»

The trouble is nuclear power is too slow to build and pass regulatory safety approvals to be of much use in limiting emissions under Paris accord timeframes.

Not exact matches

MONTREAL / SINGAPORE, April 27 - New global packaging standards expected in late 2018 will allow lithium - ion batteries back into passenger plane cargo holds, pending design and regulatory approval, but some airlines say the new rule overlooks other safety concerns.

Actual results and the timing of events could differ materially from those anticipated in the forward - looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: the uncertain timing of, and risks relating to, the executive search process; risks related to the potential failure of eptinezumab to demonstrate safety and efficacy in clinical testing; Alder's ability to conduct clinical trials and studies of eptinezumab sufficient to achieve a positive completion; the availability of data at the expected times; the clinical, therapeutic and commercial value of eptinezumab; risks and uncertainties related to regulatory application, review and approval processes and Alder's compliance with applicable legal and regulatory requirements; risks and uncertainties relating to the manufacture of eptinezumab; Alder's ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the uncertain timing and level of expenses associated with Alder's development and commercialization activities; the sufficiency of Alder's capital and other resources; market competition; changes in economic and business conditions; and other factors discussed under the caption «Risk Factors» in Alder's Annual Report on Form 10 - K for the fiscal year ended December 31, 2017, which was filed with the Securities and Exchange Commission (SEC) on February 26, 2018, and is available on the SEC's website at www.sec.gov.

These risks and uncertainties include: Gilead's ability to achieve its anticipated full year 2018 financial results; Gilead's ability to sustain growth in revenues for its antiviral and other programs; the risk that private and public payers may be reluctant to provide, or continue to provide, coverage or reimbursement for new products, including Vosevi, Yescarta, Epclusa, Harvoni, Genvoya, Odefsey, Descovy, Biktarvy and Vemlidy ®; austerity measures in European countries that may increase the amount of discount required on Gilead's products; an increase in discounts, chargebacks and rebates due to ongoing contracts and future negotiations with commercial and government payers; a larger than anticipated shift in payer mix to more highly discounted payer segments and geographic regions and decreases in treatment duration; availability of funding for state AIDS Drug Assistance Programs (ADAPs); continued fluctuations in ADAP purchases driven by federal and state grant cycles which may not mirror patient demand and may cause fluctuations in Gilead's earnings; market share and price erosion caused by the introduction of generic versions of Viread and Truvada, an uncertain global macroeconomic environment; and potential amendments to the Affordable Care Act or other government action that could have the effect of lowering prices or reducing the number of insured patients; the possibility of unfavorable results from clinical trials involving investigational compounds; Gilead's ability to initiate clinical trials in its currently anticipated timeframes; the levels of inventory held by wholesalers and retailers which may cause fluctuations in Gilead's earnings; Kite's ability to develop and commercialize cell therapies utilizing the zinc finger nuclease technology platform and realize the benefits of the Sangamo partnership; Gilead's ability to submit new drug applications for new product candidates in the timelines currently anticipated; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including Biktarvy; Gilead's ability to successfully commercialize its products, including Biktarvy; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products; Gilead's ability to successfully develop its hematology / oncology and inflammation / respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including GS - 9620 and Yescarta in combination with Pfizer's utomilumab; Gilead's ability to pay dividends or complete its share repurchase program due to changes in its stock price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (the SEC).

While we agree that safety and environmental considerations are critically important, project approvals should be based on scientific and regulatory processes and not political considerations.

If sugar substitutes are used, such as aspartame or saccharin, consumers can be assured they have gone though large scale studies to validate safety, and have gained approval from regulatory industries worldwide, including the Australian food regulator FSANZ.

Careful evaluation of these drugs is undertaken before and after regulatory approval, they explain, and that post surveillance after a drug is licensed can include safety of a medication in the general population, which unlike study populations, includes people with varied medical conditions.

The results showed 100 % protection 10 days after immunization, but the unconventional approach led Merck to put off applying for regulatory approval so it could gather more safety and immune data from other studies.

For close to two decades, the GM Crop Database has provided safety - related information about regulatory evaluations and approvals of genetically engineered plants.

The GM Crop Database contains safety related information about the regulatory evaluations and approvals of genetically modified plants.

We have commenced a series of clinical trials designed to obtain safety and efficacy data on Epidiolex to provide to the FDA and other regulatory authorities around the world, which is necessary to be considered for approval as a prescription medicine.

In response to mounting concerns about the adequacy of protection of research participants, at a regulatory level, increasing attention is being focused on safety and confidentiality of human subjects participating in research protocols.26 - 28 Beginning with applications submitted for the January 2001 council round, institutional review board (IRB) approval is no longer required prior to NIH peer review; previous NIH policy had been that IRB approval was required at the time of submission.

He said US scientists were pushing ahead and seeking regulatory approval to start safety trials of embryonic stem cells in spinal injury patients next year.

Emissions standards form part of the system of vehicle «Type Approval», the regulatory mechanism for ensuring that cars and vans sold within the EU meet minimum environmental and safety standards.

The NEB would retain its other regulatory functions (such as determining whether a pipeline may be safely opened for transmission, detailed route approvals, orders to ensure safety and security of operation of a pipeline etc.).

Tags for this Online Resume: clinical, affairs, scientific, trials, innovative, management, summary, documents, submission, regulatory, 510 (k), ISE, ISS, PK / PD, communicating, monitoring, tactical, strategic, literature, direct, vision, Lead, Director, documentation, resources, execution, consensus, effectiveness, safety, CRA, IVD, medical, device, pharmaceutical, presentation, manuscript, abstract, poster, programs, leadership, career, development, appraisals, optimize, goals, objectives, internal, external, research, investigator, stakeholders, customers, prioritize, product, support, milestones, Microsoft, Word, Excel, statistics, data, analysis, Powerpoint, publication, growth, deliverables, diagnostic, prognostic, treatment, competitive, proven, ability, capable, assess, strategy, feasibility, methodology, design, develop, produce, recommend, recommendation, therapeutic, supervision, review, performance, appraisal, application, indication, company, collaborate, expert, justification, senior, executive, assessment, experienced, marketing, pre-market, pre-IDE, protocol, communication, utility, pharmacology, service, deliver, delivery, drug, metabolism, absorption, excretion, train, training, mentor, mentoring, CRO, reimbursement, XLSTAT, Prism, relationship, contract, consult, consultant, ownership, responsibility, authority, delegate, trends, direction, in - vitro, commercialize, commercialization, approval, clearance, patient, oncology, cancer, metabolic, cardiovascular, kidney, disease, health, outcomes, safe, effective, toxicity, novel, unique, unmet, need, advisors, advisory, committee, IRB, ethical, justified, supportive, care, associate