Food Group Equivalent Examples Vegetable 1/2 cup equivalent vegetable 1/2 cup cooked green beans; 1 cup raw spinach Fruit 1/2 cup equivalent fruit 1/2 cup strawberries; 1/2 cup 100% orange juice; 1/4 cup raisins Grains No less than 3/4 oz. equivalent whole grain 1 slide of bread;...
Canadian, Mexican, Brazilian, European and Asian regulations are not similar or equivalent. Why would you take a chance? Whereas the United States has always relied on a strictly centralized process through one agency, the Food and Drug Administration (FDA), the European Commission synchronized the...
目的是证明申请上市的器械与已经在市场上的器械同样安全有效，即为等价器械(substantially equivalent)。
In the U.S. and Canada, CytoSorbents is developing the DrugSorb™-ATR antithrombotic removal system, an investigational device based on an equivalent polymer technology to CytoSorb, to reduce the severity of perioperative bleeding in high-risk surgery due to blood thinning drugs. It has received...
In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to G...
Reynolds to market its Vuse Solo closed electronic nicotine-delivery device and two accompanying tobacco-flavored e-liquid pods, which have a nicotine strength of 4.8%, which is roughly equivalent to a pack of cigarettes. Nicotine is a chemical released during the combustion of tobacco and i...
Monitor patients for new or worsening respiratory symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, fever) during treatment with Datroway. For asymptomatic (Grade 1) ILD/pneumonitis, consider corticosteroid treatment (eg, ≥0.5 mg/kg/day prednisolone or equivalent). For symptomatic ILD/pne...
(1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse r...
(1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions ...
The FDA reviewed the data for Cefaly through the de novo premarket review pathway, a regulatory pathway for generally low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device. SUGGESTED for you ...