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Environmental Law Case

Regulatory agencies are formed with the purpose of ensuring compliance with basic standards

set by the federal government. The agencies are formed after laws have been put in place by

congress so as to assign specific tasks to the agencies to avoid centralization of power.

However, this laws should be implemented in regard to the understanding of the human situation

as provided once and for all so that the best to be achieved is readily determinable as well as

eternally appreciated (Ethical considerations, n.d.). To achieve this, laws such as those that

restrict drug use are set to maintain a certain age for the drug users. Moreover, the laws are

meant to provide those they guide appropriate services such as counselling so as to ensure the

users exercise their responsibility while informed of the risks and consequences of possibly

going against the laws. This is because public health practice is best improved when personal

autonomy is valued.

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Surname Student’s Name Lecturer’s Name Date Environmental Law Case Regulatory agencies are formed with the purpose of ensuring compliance with basic standards set by the federal government. The agencies are formed after laws have been put in place by congress so as to assign specific tasks to the agencies to avoid centralization of power. However, this laws should be implemented in regard to the understanding of the human situation as provided once and for all so that the best to be achieved is readily determinable as well as eternally appreciated (Ethical considerations, n.d.). To achiev ...
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24 pages

Literature Review Supply Chain Management

The following paper is a literature review on the issue of SCM. It consists of twelve peerreviewed articles and is organiz ...

Literature Review Supply Chain Management

The following paper is a literature review on the issue of SCM. It consists of twelve peerreviewed articles and is organized into four parts that ...

Northeastern University Regulatory Affairs for Drugs Paper

Getafix Pharmaceuticals is a small start-up pharmaceutical company developing a compound it hopes to market as soon as pos ...

Northeastern University Regulatory Affairs for Drugs Paper

Getafix Pharmaceuticals is a small start-up pharmaceutical company developing a compound it hopes to market as soon as possible for treating a very rare form of pediatric brain cancer. You are working in the Regulatory Affairs Department and the CEO brings you into his office to advise the leadership team on what it would take to get that compound to market. PART I: What would you advise the Getafix Pharmaceuticals Leadership Team at that first meeting? How can the Regulatory Affairs team be most helpful here? Are there any special considerations?PART II: With nonclinical studies completed, planned, and ongoing, what advice would you give Getafix Pharmaceuticals R&D Leadership in order to best place them for IND submission?PART III: Getafix Pharmaceuticals is now planning to submit an initial IND submission to FDA. Outline operational and strategic considerations Getafix should take into account when preparing to submit its initial IND to the FDA. Indicate whether you would recommend a Pre-IND meeting with FDA, and if so, describe the contents of required meeting material and potential goals of the meeting. Describe documentation required for initial IND submission.PART IV: Getafix Pharmaceuticals has maintained an effective IND and and is ready for an NDA. Outline operational and strategic considerations Getafix should take into account throughout NDA preparation. Within your plan, provide a brief introduction describing the purpose of the NDA and its review by the FDA. Describe documentation required for initial NDA submission and outline post-approval activities Getafix would need to perform to keep the drug on the market in the United States. Also, consider the possibility of an Advisory Committee Meeting and outline steps needed to prepare for this during NDA preparation.Part V: Congratulations! The SolveIT drug was approved by the FDA due to your assistance, and has been on the market for 3 years, with profits rising over $100Million, soaring GetaFix Stock. Unfortunately, GetaFix has recently received a warning letter citing failure to report anaphylactic reactions to SolveIT at a high rate, at a recent medical conference – cell phone evidence caught the head of Medical Affairs discussing off-label uses of the drug, and a recent promotional advertisement violated fair balance requirements. What are the requirements of these violations and how would you recommend Getafix respond to this warning letter? What are the impacts of warning letters on drug companies? Each answer should be answered in more than 2 paragraphs, references should be at end of each question.

Identify the stakeholders

Please use APA style with two to three double-spaced pages in length. Please cite the reference for your research.Identif ...

Identify the stakeholders

Please use APA style with two to three double-spaced pages in length. Please cite the reference for your research.Identify the stakeholders in this case. Identify their interests and United’s obligations to satisfy those interests from an ethical perspective.Describe the ethical responsibilities of Tony Cupertino as a CPA and CIA. How do these responsibilities effect whom Cupertino should approach in United based on the organization chart?Assume Tony Cupertino decides to delay contacting Walter Hayward and, instead, Cupertino contacts the CFO of Bilco Corporation and offers a 20 percent discount on the total $130,000 cost of merchandise if Bilco agrees to approve the partial shipment on December 30, 2013. Cupertino adds that the $26,000 would be deducted from the remaining $65,000 to be shipped during January 2014. Evaluate Cupertino’s actions with respect to the following:Is the offer ethical or unethical? Why?Has Cupertino violated any of his reporting responsibilities in directly contacting the CFO of Bilco?

Stage 2 3D Printer

Stage 2 3D Printer

MK 9709 NU Tesla Global Consumers and Market Places Proposal

MK 9709 NU Tesla Global Consumers and Market Places Proposal

The litigation in the Yahoo! case took approximately six years and involved multiple appeals, law homework help

All posts must be a minimum of 250-300 words.Questions:Read the case study on pp. 241-244 of the textbook and answer the f ...

The litigation in the Yahoo! case took approximately six years and involved multiple appeals, law homework help

All posts must be a minimum of 250-300 words.Questions:Read the case study on pp. 241-244 of the textbook and answer the following questions:Questions:Read the case study on pp. 241-244 of the textbook and answer the following questions:1. The ligitation in the Yahoo! case took approximately six years and involved multiple appeals and some related criminal proceedings. What does this tell us about the actual costs of complex cyber-litigation? 2. Yahoo!'s French subsidiary, and eventually Yahoo! itself, took all Nazi paraphernalia from the site, complying with French law - what does this say about the foreign court's actual power? What Yahoo! wise to do so, or should it have defied the French court's order?Read the case study on pp. 273-274 of the textbook and answer the following questions: 3. Suppose that you were brought in to advise the Univerisity in regard to what has happened. In the process it was determined that the University did not want to file a lawsuit. What other strategies would you recommend for them to pursue? 4. With regard to the legal claims in this case, defendants were not liable; do you consider that any ethical obligations were breached? Forum Grading Rubric (100 Points)Synthesis of Concepts 55 Clear Citations using APA format 10 Writing Standards 10 Peer Reviews (minimum of 2) - Responses posted after the current week will not be accepted 25

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24 pages

Literature Review Supply Chain Management

The following paper is a literature review on the issue of SCM. It consists of twelve peerreviewed articles and is organiz ...

Literature Review Supply Chain Management

The following paper is a literature review on the issue of SCM. It consists of twelve peerreviewed articles and is organized into four parts that ...

Northeastern University Regulatory Affairs for Drugs Paper

Getafix Pharmaceuticals is a small start-up pharmaceutical company developing a compound it hopes to market as soon as pos ...

Northeastern University Regulatory Affairs for Drugs Paper

Getafix Pharmaceuticals is a small start-up pharmaceutical company developing a compound it hopes to market as soon as possible for treating a very rare form of pediatric brain cancer. You are working in the Regulatory Affairs Department and the CEO brings you into his office to advise the leadership team on what it would take to get that compound to market. PART I: What would you advise the Getafix Pharmaceuticals Leadership Team at that first meeting? How can the Regulatory Affairs team be most helpful here? Are there any special considerations?PART II: With nonclinical studies completed, planned, and ongoing, what advice would you give Getafix Pharmaceuticals R&D Leadership in order to best place them for IND submission?PART III: Getafix Pharmaceuticals is now planning to submit an initial IND submission to FDA. Outline operational and strategic considerations Getafix should take into account when preparing to submit its initial IND to the FDA. Indicate whether you would recommend a Pre-IND meeting with FDA, and if so, describe the contents of required meeting material and potential goals of the meeting. Describe documentation required for initial IND submission.PART IV: Getafix Pharmaceuticals has maintained an effective IND and and is ready for an NDA. Outline operational and strategic considerations Getafix should take into account throughout NDA preparation. Within your plan, provide a brief introduction describing the purpose of the NDA and its review by the FDA. Describe documentation required for initial NDA submission and outline post-approval activities Getafix would need to perform to keep the drug on the market in the United States. Also, consider the possibility of an Advisory Committee Meeting and outline steps needed to prepare for this during NDA preparation.Part V: Congratulations! The SolveIT drug was approved by the FDA due to your assistance, and has been on the market for 3 years, with profits rising over $100Million, soaring GetaFix Stock. Unfortunately, GetaFix has recently received a warning letter citing failure to report anaphylactic reactions to SolveIT at a high rate, at a recent medical conference – cell phone evidence caught the head of Medical Affairs discussing off-label uses of the drug, and a recent promotional advertisement violated fair balance requirements. What are the requirements of these violations and how would you recommend Getafix respond to this warning letter? What are the impacts of warning letters on drug companies? Each answer should be answered in more than 2 paragraphs, references should be at end of each question.

Identify the stakeholders

Please use APA style with two to three double-spaced pages in length. Please cite the reference for your research.Identif ...

Identify the stakeholders

Please use APA style with two to three double-spaced pages in length. Please cite the reference for your research.Identify the stakeholders in this case. Identify their interests and United’s obligations to satisfy those interests from an ethical perspective.Describe the ethical responsibilities of Tony Cupertino as a CPA and CIA. How do these responsibilities effect whom Cupertino should approach in United based on the organization chart?Assume Tony Cupertino decides to delay contacting Walter Hayward and, instead, Cupertino contacts the CFO of Bilco Corporation and offers a 20 percent discount on the total $130,000 cost of merchandise if Bilco agrees to approve the partial shipment on December 30, 2013. Cupertino adds that the $26,000 would be deducted from the remaining $65,000 to be shipped during January 2014. Evaluate Cupertino’s actions with respect to the following:Is the offer ethical or unethical? Why?Has Cupertino violated any of his reporting responsibilities in directly contacting the CFO of Bilco?

Stage 2 3D Printer

Stage 2 3D Printer

MK 9709 NU Tesla Global Consumers and Market Places Proposal

MK 9709 NU Tesla Global Consumers and Market Places Proposal

The litigation in the Yahoo! case took approximately six years and involved multiple appeals, law homework help

All posts must be a minimum of 250-300 words.Questions:Read the case study on pp. 241-244 of the textbook and answer the f ...

The litigation in the Yahoo! case took approximately six years and involved multiple appeals, law homework help

All posts must be a minimum of 250-300 words.Questions:Read the case study on pp. 241-244 of the textbook and answer the following questions:Questions:Read the case study on pp. 241-244 of the textbook and answer the following questions:1. The ligitation in the Yahoo! case took approximately six years and involved multiple appeals and some related criminal proceedings. What does this tell us about the actual costs of complex cyber-litigation? 2. Yahoo!'s French subsidiary, and eventually Yahoo! itself, took all Nazi paraphernalia from the site, complying with French law - what does this say about the foreign court's actual power? What Yahoo! wise to do so, or should it have defied the French court's order?Read the case study on pp. 273-274 of the textbook and answer the following questions: 3. Suppose that you were brought in to advise the Univerisity in regard to what has happened. In the process it was determined that the University did not want to file a lawsuit. What other strategies would you recommend for them to pursue? 4. With regard to the legal claims in this case, defendants were not liable; do you consider that any ethical obligations were breached? Forum Grading Rubric (100 Points)Synthesis of Concepts 55 Clear Citations using APA format 10 Writing Standards 10 Peer Reviews (minimum of 2) - Responses posted after the current week will not be accepted 25