Sentences with phrase «product safety and efficacy»

Not exact matches

We are very confident in the safety and efficacy of EpiPen products being produced at the site.»

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.

DuPont offers a broad range of food protection products to help you meet the rigorous standards of your food safety programs with speed, efficiency and efficacy.

Our Bloomingdale facility is at the heart of our manufacturing and distribution network and strongly supports our ability to achieve consistent levels of product quality, efficacy, and safety, as well as our ability to meet increasing consumer demand.

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.

«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.

To get through the FDA's demanding approval process, drug companies must demonstrate their product's safety and efficacy in costly randomized clinical trials.

In 1995, Brazilian pharmaceutical companies were legally required to document pharmacological efficacy and safety as well as the predictive toxicology of phytoremedies just as for as any other pharmaceutical product.

The standard pharmaceutical development path for products that target pathogens moves slowly from studying safety, dosing, and biological responses in hundreds of people to an expensive efficacy trial with thousands of participants at high risk of becoming naturally infected.

At the meeting, GlaxoSmithKline (GSK) of Rixensart, Belgium, which has the vaccine furthest in development, spelled out how it might scale up production in parallel with the safety and efficacy trials now under way so that the product could be ready for wider distribution by April if warranted.

At Merck Frosst Canada, I have been an integral part of the discovery of a new molecule, the testing of its mechanism of action, the validation of its safety and efficacy in Phase IIb and III clinical trials, the market approval of the resulting product, and the subsequent management of patients and their disease.

The Rao report says that generally, «endorsement or opposition to a generic technology is scientifically not rational,» and argues instead that «safety and efficacy must be judged on product basis.»

On «the lack of quality controls on cells,» which makes the treatment hard to replicate, thus not guaranteeing safety and efficacy of the product

Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Syndax's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes.

ViaCyte is proceeding to initiate an open - label clinical trial to evaluate the PEC - Direct product candidate for safety and definitive evidence of efficacy.

A Phase 1/2 trial to assess safety, tolerability, and efficacy of the product in human subjects with diabetes, called STEP ONE, or Safety, Tolerability, and Efficacy of VC - 01 Combination Product in Type 1, was launched in September 2014, and the first implant was announced in Octobersafety, tolerability, and efficacy of the product in human subjects with diabetes, called STEP ONE, or Safety, Tolerability, and Efficacy of VC - 01 Combination Product in Type 1, was launched in September 2014, and the first implant was announced in Octobefficacy of the product in human subjects with diabetes, called STEP ONE, or Safety, Tolerability, and Efficacy of VC - 01 Combination Product in Type 1, was launched in September 2014, and the first implant was announced in Octobeproduct in human subjects with diabetes, called STEP ONE, or Safety, Tolerability, and Efficacy of VC - 01 Combination Product in Type 1, was launched in September 2014, and the first implant was announced in OctoberSafety, Tolerability, and Efficacy of VC - 01 Combination Product in Type 1, was launched in September 2014, and the first implant was announced in OctobEfficacy of VC - 01 Combination Product in Type 1, was launched in September 2014, and the first implant was announced in OctobeProduct in Type 1, was launched in September 2014, and the first implant was announced in October 2014.

A biosimilar biotherapeutic product is similar (but not identical) in terms of quality, safety, and efficacy to an already licensed reference product.

A Phase 1/2 trial called STEP ONE, or Safety, Tolerability, and Efficacy of VC - 01 Combination Product in Type 1, was launched in September 2014, and the first implant was announced in October 2014.

The funding will help support our current clinical trial evaluating the safety and efficacy of ViaCyte's PEC - Direct product candidate, which is in development as a potential cure for patients with high - risk type 1 diabetes.

How can they be used to more accurately test the safety and efficacy of medicines, foods, and products?

The Phase 1/2 trial called STEP ONE, or Safety, Tolerability, and Efficacy of VC - 01 Combination Product in Type One Diabetes, is ongoing.

The first - in - human STEP ONE * trial is evaluating the safety and efficacy of ViaCyte's PEC - Encap (a.k.a. VC - 01 ™) product candidate, a stem cell - derived, encapsulated cell replacement therapy.

ViaCyte's VC - 01 ™ product candidate, a first - in - class cell replacement therapy for the treatment of type 1 diabetes, is currently being evaluated in a Phase 1/2 trial called STEP ONE, or Safety, Tolerability, and Efficacy of VC - 01 Combination Product in Type One Diproduct candidate, a first - in - class cell replacement therapy for the treatment of type 1 diabetes, is currently being evaluated in a Phase 1/2 trial called STEP ONE, or Safety, Tolerability, and Efficacy of VC - 01 Combination Product in Type One DiProduct in Type One Diabetes.

The Investigational New Drug application for the Phase 1/2 trial, called STEP ONE, or Safety, Tolerability, and Efficacy of VC - 01 Combination Product in Type 1, was allowed by the US Food and Drug Administration in August 2014.

The authors concluded existing regulations governing stem cells «provide an appropriate structure for ensuring the safety and efficacy of the next generation of stem - cell - based products.»

Immune Design entered into a clinical trial collaboration with Genentech, a member of the Roche Group, to evaluate the safety and efficacy of its CMB305 cancer immunotherapy product candidate combined with the investigational cancer immunotherapy atezolizumab in a randomized Phase 2 trial in patients with soft tissue sarcoma.

(Iovate Health Sciences Research Inc., which manufactures Hydroxycut, told Health: «Iovate continues to strongly believe that the products recalled on May 1, 2009, were safe... and the company made no misrepresentations pertaining to [their] safety and efficacy.

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.

Sidney Wolfe, MD, director of the Health Research Group at the consumer advocacy group Public Citizen, notes that weight - loss products have a dismal history in terms of safety and efficacy.

We drive advancement by focusing our initiatives on research, natural effectiveness, product safety, efficacy, unparalleled quality control and continuing innovation.

There are a lot of anabolic steroids that we can find in the market today but we must put at top priority the safety and efficacy of the product.

[107] Establishing guidelines to assess safety and efficacy of botanical supplement products, the European Medicines Agency provided criteria for evaluating and grading the quality of clinical research in preparing monographs about herbal supplements.

Students will deepen their knowledge of Materia Medica, and learn to evaluate the safety and efficacy of herbal products they see in their patients using.

This provides greater label transparency to prove the product's safety and efficacy.

Strict government licensing, auditing and certification procedures mean that our genuine New Zealand freeze dried products can be used with complete confidence in their origin, safety and efficacy.

Additionally, La Roche - Posay products undergo stringent clinical testing to demonstrate efficacy and safety, even on sensitive skin.

Watch this video clip to understand how La Roche - Posay skincare products are designed, formulated and tested to meet our efficacy and safety standards.

Beginning in 1906, the FDA is still responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.

«Oftentimes, consumers are misled and oversold falseness on the safety aspects and efficacy of products,» she explains.

By taking the opportunity of personal service to educate their customers on the efficacy and safety of products that are proven to be effective, [pet specialty retailers] can garner sales at a higher value and have a happy customer.»

Kiefer said that veterinarians should consider the following before working with companies that offer stem cells: what data they have provided demonstrating the efficacy and safety of their product, whether they rely on publications by other companies or groups and whether their product is an equivalent product.

For more information on these products, consult your veterinarian, as different vets have different opinions about various flea prevention products based on experience with efficacy and safety.

Conditional licensing means that there is enough evidence of safety and efficacy for the product to be made available commercially but investigation is still on - going as to how well it works.

After all, the best way to help protect horses against EIV is to vaccinate before exposure to this highly contagious respiratory disease.8 And that's why horse owners can depend on the FLUVAC INNOVATOR vaccine line, because it helps offer demonstrated protection against EIV and is backed by the Zoetis commitment to continuously monitor and evaluate the efficacy and safety of its producAnd that's why horse owners can depend on the FLUVAC INNOVATOR vaccine line, because it helps offer demonstrated protection against EIV and is backed by the Zoetis commitment to continuously monitor and evaluate the efficacy and safety of its producand is backed by the Zoetis commitment to continuously monitor and evaluate the efficacy and safety of its producand evaluate the efficacy and safety of its producand safety of its products.

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.

Our sedation medications have all been hand - selected by our veterinary surgeons, based on the safety and efficacy of each product.

«There has been no change to the formulation or manufacturing of Convenia, so veterinarians can expect the same safety and efficacy they have come to trust from this product.»