Sentences with phrase «for safety and efficacy»

Several commenters further recommended that only the following uses and disclosures be permitted for research information unrelated to treatment without authorization: (1) For the oversight of the researcher or the research study; (2) for safety and efficacy reporting required by FDA; (3) for public health; (4) for emergency circumstances; or (5) for another research study.

They have reliable efficacy plus they also carry with them the background of thorough scientific testing for both safety and efficacy that go with FDA approval (at least for dogs).

Each vaccine is carefully selected by the veterinarian for safety and efficacy.

For prevention or treatment of fleas, we recommend you talk to your veterinarian and obtain a recommendation for a product that has been extensively tested for safety and efficacy in cats.

Each bottle — dermatologist tested for safety and efficacy and suitable for sensitive skin — contains a concentrated extract of 2,000 quinoa husks.

all essential oils have their own properties and need to be looked at for safety and efficacy for what you are wanting.

Few herbal products have been widely tested for safety and efficacy in randomized, placebo - controlled trials, as the U.S. Food and Drug Administration (FDA) requires of prescriptions drugs.

The approval process involves several steps including preclinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application by the manufacturer of the drug, and FDA review and approval of the application.

He also oversees the design and execution of GLP toxicity studies, a critical final step before IDRI's vaccines can be tested for safety and efficacy in humans.

It is currently being evaluated for safety and efficacy in preclinical models with a Phase I trial expected to begin in 2019.

«Successful antagonists, following clinical trials for safety and efficacy, could be incorporated into the seasonal vaccine as a way of enhancing responses.

EOS100850 is currently being evaluated for safety and efficacy in preclinical models.

Along with our nonprofit partners, this program aims to collect, organize, and validate massive amounts of data generated by clinical trials across our global trial network sites in order to generate novel insights into biomarkers for safety and efficacy, novel treatment strategies, and personalization of treatment regimens.

Aerosol chemotherapy with cisplatin9, carboplatin8, gemcitabine16, 17, paclitaxel18, doxorubicin19, 20, 5 - Fluoracil21 and bevasizumab22 administration has been investigated for safety and efficacy.

It costs millions of dollars to develop drugs and get them tested in animals before they can ever be used in clinical trials for safety and efficacy in humans.

Michael O'Connor, Ph.D., a Mayo Clinic scientist and inventor of the MBI technology, calls this latest study a major milestone for both safety and efficacy of the imaging device, largely because of the high detection rates achieved through low radiation exposure.

Clinical trials that specifically test ADAR1 - targeted therapeutics for their safety and efficacy against multiple myeloma are still necessary before this approach could become available to patients.

The time it takes for a new drug to go from bench to prescription pad can be staggering — typically three to six years are needed for development before it's even ready for safety and efficacy testing, according to the Pharmaceutical Research and Manufacturers of America.

Ultimately, AA147 — or some version of it — would need to undergo clinical trials for safety and efficacy before it could potentially be used to treat patients.

Not exact matches

The FDA, which is the ultimate arbiter of safety and efficacy — of high quality tests that are proven to work — is the gold standard, and Theranos wants its tests to be the best and safest for its patients.

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.

Although the FDA can't dictate prices or reject therapies over pricing concerns (they can only focus on safety and efficacy), the agency can encourage more competition through moves like this (as well as speedier approval pathways) which could spur drug makers to produce products that ultimately lower costs for patients — a goal cited by FDA Commissioner Scott Gottlieb in announcing the list.

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).

Our forecast for bictegravir starts later than this implied timeline (Q3 2018) but ramps to more than $ 10bn in global sales based on the product's convenience, safety and tolerability and efficacy.

If large - scale trials can replicate safety and efficacy results, the drug could be approved for legal use by 2021.

We do this by conducting clinical trials in which we collect safety and efficacy data about our experimental drugs with the goal of submitting those data to regulatory authorities, like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), so that these experimental drugs can be approved for use by patients.

Where were the preliminary animal testing and computer models establishing some parameters of safety and efficacy for these experiments?

Greens powder for kids How to check for supplement safety / purity / efficacy Omega 3s: fish oil and algae oil What to look for with probiotics Pee turning yellow with b - complex suppleme..

But for those new parents who have been bombarded with misinformation and hearsay regarding the safety and efficacy of sleep training, it's yet another assurance that you can feel confident in the fact that getting your child to sleep through the night is important, safe, and beneficial to your entire family.

Many parents have concerns about the safety and efficacy of flu shots for children.

The DAME trial was a multi-site, randomised controlled trial of antenatal expression of colostrum in late pregnancy for women with diabetes in pregnancy to explore the safety and efficacy for mother, foetus and infant.

Safety and efficacy of antenatal milk expressing for women with diabetes in pregnancy: protocol for a randomised controlled trial.

The efficacy and safety of the probiotic bacterium Lactobacillus reuteri DSM 17938 for infantile colic: A meta - analysis of randomized controlled trials.

formulas (including those for vulnerable infants who require specialist feeds) to contain potentially risky ingredients that will not have been independently checked for efficacy and safety;

Diphenhydramine does have a long track record of safety and efficacy as an antihistamine, but it's not recommended for children under two.

Myth: The FDA puts infant formulas through rigorous testing to ensure safety and efficacy before it is released for use by infants.

The workshop, which took place on the August 28 - 29, 2017, was aimed at educating the Herbal Manufacturers on «Specifications for Herbal Products» with the aim of improving the overall quality, efficacy and product safety on the market.

For now, he cautions, CRISPR's safety and efficacy haven't been established, so parents shouldn't subject their children to the risks.

«Until we have further evidence on the efficacy of medical cannabis for the treatment of sleep apnea, and until its safety profile is established, patients should discuss proven treatment options with a licensed medical provider at an accredited sleep facility,» said lead author Dr. Kannan Ramar, professor of medicine in the division of pulmonary and critical care medicine at Mayo Clinic in Rochester, Minnesota.

«It's important for us to finish what we started... and to make sure we get the data, the safety and efficacy that's necessary to support the approval and licensure of therapeutics and vaccines,» Disbrow said.

Further studies in animal models and patients (with altered TRPM7 channel function) have been initiated, in order to evaluate the efficacy and safety of magnesium as a therapeutic for this disease.

Although gene therapy research has made great strides in recent years, it has yet to be widely deployed, and no CRISPR - edited genes have yet been tested for safety or efficacy in human clinical trials.

The CO-STAR (Hepatitis C Patients on Opioid Substitution Therapy Antiviral Response) trial sought to evaluate the efficacy and safety of elbasvir - grazoprevir for injection drug users.

«The study results elucidate the molecular mechanisms underlying disease progression in multiple sclerosis models, providing a basis for future clinical trials to determine safety and efficacy of these chemical agents in humans with demyelinating disorders,» says Patrizia Casaccia, MD, PhD, Professor of Neuroscience, Genetics and Genomic Sciences at Mount Sinai and senior author of the study.

Patients are assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and initial signals of efficacy.

«Companies would likely feel empowered to ignore requirements for demonstrable safety and efficacy of autologous medicinal products, creating an «anything goes» atmosphere,» he says.

Respondents in this year's survey pointed to five main causes of the field's less than favorable reputation: drug and product recalls such as the withdrawal of Avandia; safety issues such as the discovery of problems with raw material from China used in medical products; scandals, including evidence that pharmaceutical companies have failed to release data from trials whose results cast doubts on their drugs» safety and efficacy; lawsuits brought against companies that failed to warn patients of problems with their products; and ethical issues such as kickbacks for physicians promoting specific medications.

Following the success of this preliminary safety and feasibility study, more patients are being recruited for a larger clinical trial of the procedure to test the efficacy and durability of the procedure.

These encouraging results in terms of safety and efficacy are paving the way for a new kind of treatment, not only for Still's disease, but other rare inflammatory diseases, too.

In addition, the NFL should convene an independent committee of medical professionals, without ties to the NFL or any of its teams, to evaluate the safety and efficacy of the therapies, establishing a set of criteria for what is considered «safe» and «effective,» the authors said.