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Recently, this TIV vaccine was approved under the United States' accelerated approval regulation [ 4, 15].
S-1 was approved in Japan for AGC under an accelerated approval regulation system in 1999, and for head and neck cancer in 2001, and clinical trials against colorectal (Ohtsu et al, 2000), breast (Sano et al, 2000), and lung cancer (Kawahara et al, 2001) are now ongoing and high responses have been reported.
The results of theoretical analysis and field tests verify that antenna horizontal beamwidth smaller than 6° is a precondition for accurate and reliable field measurements, which has also been added to the newly published pattern approval regulation of ATR radar in China.
Exploration of the similarities and differences in use is a helpful strategy for planning and improving practices in drug approval, regulation, financing, reimbursement, prescribing and use by patients.
The proposal adapts the type approval regulation to require new types of passenger cars and light commercial vehicles to be constructed so as to ensure that in the event of a severe accident an emergency call (eCall) to the 112 is triggered automatically.
In addition, any future evaluation of the regulations and the setting of new effective emission limits should take into account the introduction of the new worldwide harmonised light vehicles test procedure (WLTP) in September 2017, and the entry into force of the new type approval regulation.
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Accelerated approval regulations allow the FDA to approve products based on preliminary test results, with the proviso that the company continues with clinical trials after the drug is marketed.
5 The inclusion and exclusion criteria used in randomised controlled trials excluded important patient groups for various reasons, depending on general approval regulations by health authorities or specific concepts developed and approved by local ethics committees.
The FDA must ramp up its education and ensure that it avoids subjecting basic consumer-facing health apps to years of waiting for approval, regulations, and red tape.
Proposed study designs for approval based on a surrogate endpoint and a post-marketing confirmatory study under FDA's accelerated approval regulations for disease modifying osteoarthritis drugs.
Samples for the high resolution melt assay were purchased as either DNA or tissue blocks from vendors who provided unlinked anonymized specimens collected in accordance with applicable review boards approval, regulations and laws.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com