Ans- Like blood itself flowing through the human circulatory network, several billion prescriptions and hundreds of billions of drugs course every year through the vast web of factories, wholesale suppliers, hospitals, physicians’ offices, pharmacies, medicine cabinets, and pill boxes that together compose the health system in the United States.
1.That network comprises a vast social machine; besides money, the main lubricant is trust premised on evidence. Physicians prescribe drugs in part because they know they have been tested and that their initial safety and efficacy has met the approval criteria of the US Food and Drug Administration (FDA).
2.When a generic medication is prescribed, the physician trusts, consciously or unconsciously, that basic conditions of quality manufacturing and bioequivalence have been met. In most instances, the physician does not see the evidence but assumes that someone else, principally the FDA, has rigorously reviewed the underlying data.
Can Expedited FDA Drug Approval Without Expedited Follow-up Be Trusted?
Can Expedited FDA Drug Approval Without Expedited Follow-up Be Trusted? explain your answer in details
FDA approval of a drug indicates that the drug may be advertised only for the particular indication for which it was studied. True False
Question 5 (1 point) Structure and Function claims can be made without FDA approval if the claims do not mention a disease or symptom. True False
Should the FDA be able to make exceptions to the standard drug-approval process? If so, what issues should the FDA consider in deciding whether an exception should be made?
Public Health What does FDA approval of a drug imply? Select all that apply. Select one or more: O A. The drug may be used by prescribing clinicians for any patient. B. The drug may be advertised and marketed for the indication for which is was approved. O C. The drug may only be prescribed for the indications approved by the FDA. D. The drug may be advertised for both approved indications and off-label prescribing. O E. The physician can...
What incentives does the FDA have regarding drug approvals, according to some FDA critics? The FDA is more concerned with preventing approval of a drug that results in people dying than it is with approving a drug that benefits unidentifiable patients whose lives might be saved if the drug is approved earlier. The FDA is more concerned with preventing statistical deaths than with “visible” or “identifiable” lives. The FDA is too quick to approve new drugs because of pressure from...
Which of the following statements CANNOT appear on a food label without FDA approval? Helps preserve healthy vision May reduce arthritis pain Maintains healthy blood glucose levels Reduces oxidative damage
The approval of a pharmaceutical agent by the FDA requires extensive non-clinical and pre-clinical testing prior to submitting an IND application, which must be approved before the initiating the 3 phases of clinical trials. Even after the successful completion of the clinical trials and FDA review and approval of these clinical results, the drug is subject to post-marketing surveillance. Attached is an article as an example, write a 400-600 word description of why is this post-marketing review is essential to...
A start-up biomedical engineering firm has begun manufacturing a drug-coated bimetallic stent, which is a thin wire mesh tube inserted in clogged coronary arteries to prop them open and prevent future heart attacks. Identify the following costs of manufacturing the stents as either sunk or avoidable costs now that the firm has received final approval from the Food and Drug Administration (FDA) and manufacturing is currently in progress: a. Biomedical research and development costs to design the heart stent. b....
Question2 (A) The US Federal Drugs Administration (FDA) recently approved a drug for a rare fatal genetic disease that had only been trialled on 12 patients, without a placebo. One condition of the approval is that the company must carry out a more complete trial, even though sufferers can receive the drug because it is approved. Why will it be difficult to carry out such a trial? (B) A recent study reported that upper class people spent less time than...