Approval has been granted meaning

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approval has been granted meaning

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Blog Press Information Linguee Apps. The sale or installation on a vehicle of new replacement pollution control devices intended to be fitted on vehicles approved under this Regulation and its implementing measures shall be prohibited if.

U L approval has been granted f o r the plug [ Trusted Shops can grant sub-licences so that. If the vehicle conforms to a vehicle type approved under one or more other Regulations annexed to this Agreement, in the country which has granted approval under this Regulation, the symbol prescribed in paragraph 4.

O n c e approval has been granted b y t he NBP, applicants [ The tyre bearing the EC type-approval mark shown above is a commercial. If the vehicle conforms to a vehicle type approved, under one or more other Regulations annexed to the Agreement, in the country which has granted approval under this Regulation, the symbol prescribed in paragraph 5.

Every leak component or air-conditioning system conforming to a type in. If at any time you would like to make a purchase, but do not want to provide your credit card information online, you. Advertising and offering goods and services on the Park area. Akcje reklamowe na terenie parku oraz. Whether railway.

Where a manufacturer w h o has been granted a n E U whole-vehicle ty p e - approval i s o bliged, in accordance with [ Whenever an approval is withdrawn by a Member State from an SA belonging to a groupof companies, Member States which have approved SAs belonging to the same group, shall suspend the approvals of these SAs for a period not exceeding three months in order to carry out the necessary investigations.

In order to be granted type-approval to this Regulation for a vehicle. W celu uzyskania zgodnie z niniejszym regulaminem homologacji typu. Paragraph 2 shall not apply to vehicles which do not differ with respect to their essential aspects of bodywork.

The obligations of the seller in respect of the indemnity undertaking for unknown claims lapse five years after the conclusion of the share purchase agreement.

Please click on the reason for your vote: This is not a good example for the translation above. The wrong words are highlighted. It does not match my search. It should not be summed up with the orange entries The translation is wrong or of bad quality.

Thank you very much for your vote! You helped to increase the quality of our service. The sale or installation on a vehicle of new replacement pollution control devices intended to be fitted on vehicles approved under this Regulation and its implementing measures shall be prohibited if [FDA is globally respected for its scientific standards of vaccine safety, effectiveness and quality.

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The agency provides scientific and regulatory advice to vaccine developers and undertakes a rigorous evaluation of the scientific information through all phases of clinical trials, which continues after a vaccine has been approved by FDA or authorized for emergency use.

FDA recognizes the gravity of the current public health emergency and the importance of facilitating availability, as soon as possible, of vaccines to prevent COVID - vaccines that the public will trust and have confidence in receiving. An Emergency Use Authorization EUA is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID pandemic.

Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Once submitted, FDA will evaluate an EUA request and determine whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to FDA.

Clinical trials are evaluating investigational COVID vaccines in tens of thousands of study participants to generate the scientific data and other information needed by FDA to determine safety and effectiveness.

These clinical trials are being conducted according to the rigorous standards set forth by the FDA. Initially, in phase 1, the vaccine is given to a small number of generally healthy people to assess its safety at increasing doses and to gain early information about how well the vaccine works to induce an immune response in people.

In the absence of safety concerns from phase 1 studies, phase 2 studies include more people, where various dosages are tested on hundreds of people with typically varying health statuses and from different demographic groups, in randomized-controlled studies.

These studies provide additional safety information on common short-term side effects and risks, examine the relationship between the dose administered and the immune response, and may provide initial information regarding the effectiveness of the vaccine. In phase 3, the vaccine is generally administered to thousands of people in randomized, controlled studies involving broad demographic groups i.

This phase provides additional information about the immune response in people who receive the vaccine compared to those who receive a control, such as a placebo.

COVID vaccines are undergoing a rigorous development process that includes tens of thousands of study participants to generate the needed non-clinical, clinical, and manufacturing data. FDA will undertake a comprehensive evaluation of this information submitted by a vaccine manufacturer. For an EUA to be issued for a vaccine, for which there is adequate manufacturing information to ensure quality and consistency, FDA must determine that the known and potential benefits outweigh the known and potential risks of the vaccine.

From a safety perspective, FDA expects an EUA submission will include all safety data accumulated from phase 1 and 2 studies conducted with the vaccine, with an expectation that phase 3 data will include a median follow-up of at least 2-months meaning that at least half of vaccine recipients in phase 3 clinical trials have at least 2 months of follow-up after completion of the full vaccination regimen.

In addition, FDA expects that an EUA request will include a phase 3 safety database of well over 3, vaccine recipients, representing a high proportion of participants enrolled in the phase 3 study, who have been followed for serious adverse events and adverse events of special interest for at least one month after completion of the full vaccination regimen.

Sufficient data should be submitted to ensure the quality and consistency of the vaccine product. FDA will use all available tools and information, including records reviews, site visits, and previous compliance history, to assess compliance with current good manufacturing practices. The FDA staff are career scientists and physicians who have globally recognized expertise in the complexity of vaccine development and in evaluating the safety and effectiveness of all vaccines intended to prevent infectious diseases.

These FDA professionals are committed to decision-making based on scientifically driven evaluation of data. FDA staff are like your family - they are fathers, mothers, daughters, sons, sisters, brothers and more. They and their families are also directly impacted by the work that they do, and are exactly who you want making these important public health decisions for the United States. FDA expects vaccine manufacturers to include in their EUA requests a plan for active follow-up for safety, including deaths, hospitalizations, and other serious or clinically significant adverse events, among individuals who receive the vaccine under an EUA, to inform ongoing benefit-risk determinations to support continuation of the EUA.

FDA also expects manufacturers who receive an EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue licensure approval. Post-authorization vaccine safety monitoring is a federal government responsibility shared primarily by FDA and the U. Post-authorization safety monitoring during the COVID pandemic vaccination program will aim to continuously monitor the safety of COVID vaccines to rapidly detect safety problems if they exist.

There will be multiple, complementary systems in place with validated analytic methods that can rapidly detect signals for possible vaccine safety problems. The U. FDA must ensure that recipients of the vaccine under an EUA are informed, to the extent practicable given the applicable circumstances, that FDA has authorized the emergency use of the vaccine, of the known and potential benefits and risks, the extent to which such benefits and risks are unknown, that they have the option to accept or refuse the vaccine, and of any available alternatives to the product.

In public health emergencies, such as a pandemic, the development process may be atypical. In addition, the federal government has made investments in the necessary manufacturing capacity at its own risk, giving companies confidence that they can invest aggressively in development and allowing faster distribution of an eventual vaccine.

However, efforts to speed vaccine development to address the ongoing COVID pandemic have not sacrificed scientific standards, integrity of the vaccine review process, or safety.

What’s the difference between FDA approval and authorization?

Early in a public health crisis, FDA provides clear communication to the pharmaceutical industry pertaining to the scientific data and information needed to ensure development of vaccines and works quickly to provide advice on their proposed development plans and assessment of the data that are generated.

Vaccine manufacturers are undertaking a development process that includes tens of thousands of study participants to generate non-clinical, clinical, and manufacturing information needed by FDA for the agency to determine whether the known and potential benefits outweigh the known and potential risks of a vaccine for the prevention of COVID When the phase 3 portion of the human clinical trial reaches a predetermined point that informs how well a vaccine prevents COVID, as discussed and agreed to in advance with FDA, an independent group called a data safety monitoring board will review the data and inform the manufacturer of the results.

Based on the data and the interpretation of the data by this group, manufacturers decide whether and when to submit an EUA request to FDA, taking into consideration input from FDA.Add permission to one of your lists below, or create a new one. An article of clothing and a ray of sunshine: making uncountable nouns countable 2. Definitions Clear explanations of natural written and spoken English. Click on the arrows to change the translation direction. Follow us. Choose a dictionary. Clear explanations of natural written and spoken English.

Usage explanations of natural written and spoken English. Word Lists. Choose your language. My word lists. Tell us about this example sentence:.

The word in the example sentence does not match the entry word. The sentence contains offensive content. Cancel Submit. Your feedback will be reviewed. B1 If someone is given permission to do something, they are allowed to do it:.

Official permission has been granted for more building near the river.

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The authorities have refused permission for the demonstration to take place. UK Planning permission was refused for the proposed superstore. US Zoning permission was refused for the proposed superstore. Has the director given you permission to do that? We've received permission to go ahead with the music festival in spite of opposition from local residents. You'll pay some hefty bank charges if you go overdrawn without permission.

The local council refused him planning permission to build an extra bedroom. You have to ask permission to leave. Allowing and permitting. Grammar Permit or permission? Parents have to give their permission for their children to go on school trips.

approval has been granted meaning

They did the work without permission and without an official budget. Don't give permission to websites to install programs or files on your PC.See more words from the same year. Accessed 7 Mar. Nglish: Translation of approval for Spanish Speakers.

Britannica English: Translation of approval for Arabic Speakers. What made you want to look up approval? Please tell us where you read or heard it including the quote, if possible. Subscribe to America's largest dictionary and get thousands more definitions and advanced search—ad free!

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How to use a word that literally drives some pe The awkward case of 'his or her'. Take this quiz and discover 12 words for things y Test your visual vocabulary with our question Login or Register. Thesaurus approval noun. Save Word. Synonyms for approval. Words Related to approval. Phrases Synonymous with approval. Near Antonyms for approval. Antonyms for approval. Keep scrolling for more. Learn More about approval. Share approval Post more words for approval to Facebook Share more words for approval on Twitter.

Time Traveler for approval The first known use of approval was in See more words from the same year.

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Thesaurus Entries near approval appropriating appropriation appropriations approval approvals approve approved See More Nearby Entries.

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Comments on approval What made you want to look up approval? Get Word of the Day daily email! Test Your Vocabulary. Test your visual vocabulary with our question challenge! Anagram puzzles meet word search. Love words?We use cookies and other tracking technologies to improve your browsing experience on our site, show personalized content and targeted ads, analyze site traffic, and understand where our audiences come from.

To learn more or opt-out, read our Cookie Policy. Approval means the FDA has officially decided that a product is safe and effective for its designated use. The process for approval involves rigorous reviews of all available data on the product and can take several months. An EUA, as its name implies, authorizes a product for use during unusually urgent circumstances if the benefits of its use outweigh any known or potential risks.

At that point, the pharmaceutical companies will decide if they want to seek FDA approval. FDA reviewers still had to pore over all the currently available data from clinical trials before signing off on the Pfizer and BioNTech vaccine. The FDA groups medical devices into three classes based on the level of risk associated with their use. Others can be cleared by the FDA if they can show that they are similar enough to products that have already been reviewed.

approval has been granted meaning

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Patent Granted vs Published: Everything You Need to Know

Film TV Games. Fortnite Game of Thrones Books. Comics Music. Filed under: Science Coronavirus. Linkedin Reddit Pocket Flipboard Email. FDA headquarters in Maryland. Next Up In Science. Sign up for the newsletter Processor A newsletter about computers Email required. By signing up, you agree to our Privacy Notice and European users agree to the data transfer policy. Share this story Twitter Facebook.Please supply the sentence within which you wish to include the word or words. Mister Micawber.

We've obtained the necessary approval for this project. It's hard to tell what you mean, but this is one way you could say you had the approval to do a certain project. Students: Are you brave enough to let our tutors analyse your pronunciation? The sentence, "Approvals have been secured. The only issue I might have with it is that the word "secured" is rather formal usage, as compared to "granted" -- this is with respect to current American usage, as opposed to British usage, which can be quite different from American usage.

Also, generally you get a single approval for something, so the use of the plural for approval is rather unusual -- unless multiple approvals need to be obtained in this particular situation. These are acceptable: approval has been received approval has been granted approval has been secured. Teachers: We supply a list of EFL job vacancies. Make sure to use "an" or "the" in front of those sentences Mister Micawber gave you, whichever best fits your situation.

An approval has been received.

approval has been granted meaning

The approval has been received. I think the noncountable form is the usual, Chalk. The article is not usually used. Here are some examples: Approval has been given for state aid to link Shetland to the mainland. Unlike planning permission, work may start before approval has been granted. No application for approval has been made, whether refused or pending Approval has been granted for the use of Avonex Pen in patients with relapsing multiple sclerosis MS Once approval has been received to dispose of confidential recordsEthical approval has been granted.

Full ethics approval has been granted. Institutional ethics approval has been granted. Ethical approval has been granted by the French Ethics Committee. Ethics approval has been granted at all 10 study sites. Thanks to Ludwig my first paper got accepted! The editor wrote me that my manuscript was well-written. Ludwig is the first sentence search engine that helps you write better English by giving you contextualized examples taken from reliable sources. By clicking "I Accept" or "X" on this banner, or using our site, you accept our cookie and privacy policy.

Learn Ludwig. Sentence examples for approval has been granted from inspiring English sources. Save sentence. Show context. The Journal of Chinese Sociology. BMJ Open. BMC Musculoskeletal Disorders. BMC Pediatrics. Sign up for free or try Premium free for 15 days.

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