Order ID 53563633773 Type Essay Writer Level Masters Style APA Sources/References 4 Perfect Number of Pages to Order 5-10 Pages Description/Paper Instructions
Purpose:
Drug update monitoring using FDA CDER email alerts. Periodically each year the FDA approves new first time generics. These are ANDA and BLA drug applications. Many ANDA are first time for a specific company even though a different company already receive ANDA approval.There are several approaches, but the following is the most error free for novice users.
Notice the difference between NDA, ANDA, and BLA. Glossary of terms:
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=glossary.page
Thread 1 direction and questions, Directions
- Once you select your drug, please post a quick message stating your drug selection in the thread. This will prevent duplication of drugs. You can quickly post “I have selected new generic drug (name). I will post the rest of my answers in near future.” So i selected “Amantadine Hydrochloride’
this is the link to the selected drug,has companys name: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?ApplNo=214284&event=overview.process&utm_medium=email&utm_source=govdelivery
- Question parts a-c to answer- Remember to label your answers please. Your page length is cumulative of the all the answers in all the threads.
Part a. Each student should post information about one original abbreviated new drug approval (e.g. first time generic drug) approved since the beginning of the semester. This can be an abbreviated new drug (ANDA). The drugs will have “Orig-1” in the submission column. Please include details about the drug (New company name, indication, pharmacodynamics, dosing, side effects, warnings, etc) in your answer. You may find details by accessing the FDA approved label for the drug that can be found via “Drugs@FDA” or Repository of FDA labels search.
Select from FDA CDER Emails Date ranges: August -October 2020
Caution: Sometimes, the new generic version approval is for an additional generic version manufactured by an additional company. In other words, sometimes there are multiple companies that manufacture the same generic drug. Each company needs FDA approval. So be sure you are specific about your information. Is this first time generic version never on market before, or is it an additional generic version by a different company than previously approved?
HINT: You won’t find an FDA label for the ANDAs. You have to use an NDA previous approved drug to access the label. Why? Because the drug company for the ANDA approval does not need to repeat the full clinical trial to obtain approval and it will have the same information. You might need to consult drug information book to find pharmacodynamic, pharmacokinetic, and indication information about the drugs.
Part b. Mandatory: Provide the date of the CDER email used for your answer.
the date is : CDER New: 10/19/2020
Part c. Mandatory: Use appropriate FDA web site URLs used for your inform
This is original drug label( Trade Name): https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208944lbl.pdf
QUESTION 2
The Questions to Answer. Directions Specific to the Thread 1 topic. My drug selection is ” ”INMAZEB ” i HAVE ATTACHED THE DRUG LABEL TO ANSWER ALL THE DETAILS.
- Once you select your drug, please post a quick message stating your drug selection in the thread. This will prevent duplication of drugs. You can quickly post “I have selected new drug (name). I will post the rest of my answers in near future.”
- Question parts a-c to answer- Remember to label your answers please. Your page length is cumulative of the all the answers in all the threads. There is no page requirement for the question parts or each thread.
Part a. Each student should post information about one Original drug Approval since the beginning of the semester. This can be a new drug (NDA) or biologic (BLA). Please include details (indication, pharmacodynamics, dosing, side effects, warnings, etc) about the drug in your answer. You may find details by accessing the FDA approved label for the drug that can be found via “Drugs@FDA” search.
There will be a code such as Type 1 New Molecular Entity in the submission classification column. Codes type 1, 2, and 4 are new first time in terms of never been on market in any other molecular type. Please be sure you are posting information about original drug approval on the market for the first time. Do not post information about new generics or modified generics in this thread.
Part b. Mandatory: Provide the date of the CDER email used for your answer
This was sent to me on this date: CDER New: 10/16/2020
This is the fda website where i went to access the label: the company who manufactured the drug can be checked on the site attached below
Part c. Mandatory: Use appropriate FDA web site URLs used for your information
I USED THIS WEBSITE TO SELECT THE DRUG FOR QUESTION 2
THIS IS URL FOR LABEL: INMAZEB
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761169s000lbl.pdf
Question 3
Directions Specific to Thread 3.
- 1. Once you select your drug, please post a quick message stating your drug selection in the thread. This will prevent duplication of drugs. You can quickly post “I have selected label revised of previously approved drug (name). I will post the rest of my answers in near future.” I selected Cymbalta for question 3. I have attached the new revised label for cymbalta and the orignal label for cymbalta for the compare and contrast.
- Question parts a-c to answer- Remember to label your answers please. Your page length is one and a half excluding references. Single spaced, Ariel 12.
Part a. Each student should post information about one drug that has “Supplement to the new Drug applictions (NDAs and BLAs) that was approved since the beginning of the semester.This can be a new drug (NDA or BLA) or abbreviated new drug (ANDA). The classification code “SUPPL-X” (where X is a number) is in the submission column. You will typically see the term “labeling revision” in the submission classification column.
Please include details about the drug in your answer. What is revised as compared to the pre-existing approval? Each student is not expected to discuss all the new labeling revisions. Please share the information because there is “plenty to go around”.
This is the link to the new label ( revised label)of cymbalta: file:///C:/Users/Matilda/Desktop/assignment%20three%20cymbalta%20new%20label.pdf
This is the link to the original label for cymbalta( first time in the market): file:///C:/Users/Matilda/Desktop/cymbalta%20assignment%203%20original%20label.%20first%20label.pdf
HINT: You won’t find an FDA label for the ANDAs. You have to use an NDA previous approved drug to access the label. Why? Because the drug company for the ANDA approval does not need to repeat the full clinical trial to obtain approval and it will have the same information.
You will often see a list of changes with the dates on the first page of the FDA drug label.
You might need to consult drug information book to find pharmacodynamic, pharmacokinetic, and indication information about the drugs.
Part b. Mandatory: Provide the date of the CDER email used for your answer.
I got it on this date : CDER New: 10/5/2020
Part c. Mandatory: Use appropriate FDA web site URLs used for your information
RUBRIC
QUALITY OF RESPONSE NO RESPONSE POOR / UNSATISFACTORY SATISFACTORY GOOD EXCELLENT Content (worth a maximum of 50% of the total points) Zero points: Student failed to submit the final paper. 20 points out of 50: The essay illustrates poor understanding of the relevant material by failing to address or incorrectly addressing the relevant content; failing to identify or inaccurately explaining/defining key concepts/ideas; ignoring or incorrectly explaining key points/claims and the reasoning behind them; and/or incorrectly or inappropriately using terminology; and elements of the response are lacking. 30 points out of 50: The essay illustrates a rudimentary understanding of the relevant material by mentioning but not full explaining the relevant content; identifying some of the key concepts/ideas though failing to fully or accurately explain many of them; using terminology, though sometimes inaccurately or inappropriately; and/or incorporating some key claims/points but failing to explain the reasoning behind them or doing so inaccurately. Elements of the required response may also be lacking. 40 points out of 50: The essay illustrates solid understanding of the relevant material by correctly addressing most of the relevant content; identifying and explaining most of the key concepts/ideas; using correct terminology; explaining the reasoning behind most of the key points/claims; and/or where necessary or useful, substantiating some points with accurate examples. The answer is complete. 50 points: The essay illustrates exemplary understanding of the relevant material by thoroughly and correctly addressing the relevant content; identifying and explaining all of the key concepts/ideas; using correct terminology explaining the reasoning behind key points/claims and substantiating, as necessary/useful, points with several accurate and illuminating examples. No aspects of the required answer are missing. Use of Sources (worth a maximum of 20% of the total points). Zero points: Student failed to include citations and/or references. Or the student failed to submit a final paper. 5 out 20 points: Sources are seldom cited to support statements and/or format of citations are not recognizable as APA 6th Edition format. There are major errors in the formation of the references and citations. And/or there is a major reliance on highly questionable. The Student fails to provide an adequate synthesis of research collected for the paper. 10 out 20 points: References to scholarly sources are occasionally given; many statements seem unsubstantiated. Frequent errors in APA 6th Edition format, leaving the reader confused about the source of the information. There are significant errors of the formation in the references and citations. And/or there is a significant use of highly questionable sources. 15 out 20 points: Credible Scholarly sources are used effectively support claims and are, for the most part, clear and fairly represented. APA 6th Edition is used with only a few minor errors. There are minor errors in reference and/or citations. And/or there is some use of questionable sources. 20 points: Credible scholarly sources are used to give compelling evidence to support claims and are clearly and fairly represented. APA 6th Edition format is used accurately and consistently. The student uses above the maximum required references in the development of the assignment. Grammar (worth maximum of 20% of total points) Zero points: Student failed to submit the final paper. 5 points out of 20: The paper does not communicate ideas/points clearly due to inappropriate use of terminology and vague language; thoughts and sentences are disjointed or incomprehensible; organization lacking; and/or numerous grammatical, spelling/punctuation errors 10 points out 20: The paper is often unclear and difficult to follow due to some inappropriate terminology and/or vague language; ideas may be fragmented, wandering and/or repetitive; poor organization; and/or some grammatical, spelling, punctuation errors 15 points out of 20: The paper is mostly clear as a result of appropriate use of terminology and minimal vagueness; no tangents and no repetition; fairly good organization; almost perfect grammar, spelling, punctuation, and word usage. 20 points: The paper is clear, concise, and a pleasure to read as a result of appropriate and precise use of terminology; total coherence of thoughts and presentation and logical organization; and the essay is error free. Structure of the Paper (worth 10% of total points) Zero points: Student failed to submit the final paper. 3 points out of 10: Student needs to develop better formatting skills. The paper omits significant structural elements required for and APA 6th edition paper. Formatting of the paper has major flaws. The paper does not conform to APA 6th edition requirements whatsoever. 5 points out of 10: Appearance of final paper demonstrates the student’s limited ability to format the paper. There are significant errors in formatting and/or the total omission of major components of an APA 6th edition paper. They can include the omission of the cover page, abstract, and page numbers. Additionally the page has major formatting issues with spacing or paragraph formation. Font size might not conform to size requirements. The student also significantly writes too large or too short of and paper 7 points out of 10: Research paper presents an above-average use of formatting skills. The paper has slight errors within the paper. This can include small errors or omissions with the cover page, abstract, page number, and headers. There could be also slight formatting issues with the document spacing or the font Additionally the paper might slightly exceed or undershoot the specific number of required written pages for the assignment. 10 points: Student provides a high-caliber, formatted paper. This includes an APA 6th edition cover page, abstract, page number, headers and is double spaced in 12’ Times Roman Font. Additionally, the paper conforms to the specific number of required written pages and neither goes over or under the specified length of the paper. GET THIS PROJECT NOW BY CLICKING ON THIS LINK TO PLACE THE ORDER
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