Sentences with phrase «requiring additional drugs»

Not exact matches

While the Food and Drug Administration (FDA) did not require approval of cryotherapy because it is a non-invasive procedure, the company believes that additional studies can help business with the added confirmation and explanation of benefits, as well as increase exposure of cryotherapy to the mainstream.

The documentation ranges across the whole spectrum of drug development: Investigators» brochures provide information on all that is currently known about the medicine and so need periodic updating; accurate and concise protocols are required to ensure that trials are performed effectively; clinical trial reports (generally from phase II and III studies) present the information gathered from the trials; higher level documents provide summaries of efficacy and safety data from clinical trial programmes; expert reports provide critical interpretation of the results; and response documents clarify any points that are not clear to the regulatory agencies or provide additional analyses or supporting data for any items of concern.

But by 12 days, the physiological changes required to extend lifespan were complete and lifelong exposure to the drug had no additional effect.

The FDA decided in this case that the benefit was sufficient to warrant approval of the drug without requiring any additional biomarker testing.

According to a wellness report by Berkley University, the Food and Drug Administration (FDA) categorizes BHT as GRAS (generally recognized as safe), however the report indicates that BHT never underwent a pre-market review and that subsequent reviews supported their general safety but concluded that «uncertainties exist, requiring that additional studies be conducted.»

The FDA is now requiring drug companies to add an additional WARNING to their cholesterol lowering statins (or HMG - CoA reductase inhibitors).

(h) As an employer, you may also be required to take additional actions required by DOT agency regulations (e.g., FAA rules require some positive drug tests to be reported to the Federal Air Surgeon).

- Examine vehicle to determine if additional safety or service work is required - Advise Manager if additional work is needed - Document all work performed as soon as job is completed - Attend factory sponsored training classes and keep abreast of factory technical bulletins - Understand and follow federal, state and local regulations such as disposal of hazardous wastes - Ensure that vehicles are kept clean - Perform all other duties as assigned - Follow all company safety policies and procedures & immediately report any and all accidents to Manager or Supervisor REQUIREMENTS: - High School Diploma or equivalent - ASE Certification preferred - Automotive Technician - Minimum 2 years previous experience - Excellent driving record - Self - motivated with ability to perform quality work with efficiency - All applicants must be authorized to work in the USA - All applicants must have the ability to pass pre-employment testing to include background checks, MVR, drug test, and valid driver's license - All applicants must perform duties and responsibilities in a safe manner - Ability to read & comprehend instructions and information - Personal & Professional Integrity - Desire for long - term employment If you're looking to work in a progressive environment with a rapidly growing organization, than we have a position available for you.

Cats with severe manifestations of feline heartworm disease may require additional supportive therapy, and may benefit from intravenous fluids, oxygen therapy, cage confinement, bronchodilators (which expand the air passages of the lungs), cardiovascular drugs, antibiotics and nursing care.

Thus, additional tests for sensitivity towards any specific anti — parasitic drug may be required prior to treatment.

Interface with customer service, health care professionals, caregivers, and patients to gather additional information required for complaint investigations and adverse drug experience (ADE) reporting.

, before making long - term court orders which may limit their contact with children or require additional treatment (batterers treatment, drug treatment, further counseling, etc.).

In addition to drug treatment, I will assess the person to see if additional services are required, such as medical services, family therapy, parenting support, and social and legal services,