Ans: No, drugs introduced in the market with expedited FDA approval can't really be trusted. Billions of drugs are prescribed every year by physicians as they trust the US Food and Drug Administration (FDA) criteria for testing the safety and efficacy of drugs. Expedited drug approval by FDA introduces poor-quality drugs in the market and health care management system which further exposes patients to needless risks. Drugs that get expedited approval are tested on less than one-fifth of the median number of patients when compared to drugs with the standard review. Drugs clinical efficacy and safety should be stringently monitored by testing them on a larger fraction of patients and doing more follow-ups with rigorous research.
Can Expedited FDA Drug Approval Without Expedited Follow-up Be Trusted? explain your answer in details
Can Expedited FDA Drug Approval Without Expedited Follow-up Be Trusted?
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
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...
Answer the following question about the Drug Depakote, classification, FDA-approved uses, and off-label uses (if any). If your medication is controlled, please list the federal, regulations, your state's regulations, and best practices regarding dispensing. Explain how the drug works and the mechanism of action. List the most common side effects and any black box warnings. State the starting dose and how you would taper up and taper off the medication. State what should be included for patient education. Call two...
Please read the following article: Your Google Searches Could Help the FDA Find Drug Side Effects The Food and Drug Administration is talking to Google about how the search engine could help the agency identify previously unknown side effects of medications. Agency officials held a conference call on June 9 with a senior Google researcher who co-wrote a 2013 paper about using search query data to identify adverse drug reactions, according to a record of the meeting posted to the...
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...
A) Can we skip animal studies while evaluating biomaterials? Explain your answer (2pts) B) PLGA, a degradable polymer, has been approved by FDA for drug delivery applications. A bioengineering decides to use PLGA for wound healing bandages. Which methods/stages of biomaterial evaluations does the company need to perform? (2 pts)
please answer 1,3, and 4 is ethical issues class EXPLORING THE ISSUE Can Science Be Trusted Without Government Regulation? Critical Thinking and Reflection 1. What is "discovery bias"? Is there anything similar in other fields (such as "treatment bias" in medicine or "driving bias" in errand-running)? 2. Is there anything similar to "discovery bias" in other fields (such as "treatment bias" in medicine or "driving bias" in errand-running)? 3. Do such biases limit our ability to see alternatives? 4. Does...
Question 6 Select one answer. The Food and Drug Administration (FDA) is a U.S. government agency that regulates (you guessed it) food and drugs for consumer safety. One thing the 10 points FDA regulates is the allowable insect parts in various foods. You may be surprised to know that much of the processed food we eat contains insect parts. An example is flour. When wheat is ground into flour, insects that were in the wheat are ground up as well....
Question 6 Select one answer The Food and Drug Administration (FDA) is a U.S. government agency that 10 points regulates (you guessed it) food and drugs for consumer safety. One thing the FDA regulates is the allowable insect parts in various foods. You may be surprised to know that much of the processed food we eat contains insect parts. An example is flour. When wheat is ground into flour, insects that were in the wheat are ground up as well....