The pemetrexed 2nd line accelerated approval by FDA versus approval by EMEA based on PFS and the Avastin FDA 1st line indication in combination with carbo-cisplatin versus the EMEA indication in combination with broader platinum based chemo based on PFS in the AVAiL trial illustrate the different attitudes of FDA and EMA to use of PFS for approvals in NSCLC. Another example of the difference in Agency approaches to the use of PFS is provided by the case of Avastin in combination with paclitaxel for breast
treatment and if any specialty agency would need to be contacted. Ignoring these regulations can cause damage that is un-repairable.
Your statement about Bart truly feeling everything he has to say is not only correct but beneficial to the class may be entirely true! During Bart's limited exposure and experience as a BLS provider for a local non transport agency it is quite possible that he may observed or discussed with a fellow first responders additional information not learned in the BLS EMT class weather or not it is correct and he has found it beneficial in his first response practice. Additionally Bart appears to want to show his knowledge in attempt to fit in or show off. The problem with this behavior it can be distracting to his fellow students, if the information is incorrect it could cause confusion for the other students. Additionally this behavior distracts
Aaron, you have demonstrated knowledge of Department policies and procedures and pose questions when concerns arise. You have demonstrated an understanding and practice of HIPAA laws as is evident in your ability to remain confidential with all investigations despite ongoing inquiries from those that are not authorized including Reporters and various family members. Aaron, you have demonstrated knowledge of the Department’s goals and also Division programs as evidenced by your investigative plans including requests for HCBS, assistance with Medicaid applications and reinvestigations, and care plan or provider changes. Many of these cases required follow up after case closure which you completed thoroughly. Throughout your hotline investigations,
1. Mrs. Smith had a pregnancy test. Mr. Smith called Mrs. Smith’s physician and requested a copy of Mrs. Smith’s test results. Can/Should the physician release the results of the pregnancy test to Mr. Smith over the phone? (Use law and ethics to defend your answer) Why or why not?
No, even though hospitals are obligated to provide a medical exam and stabilizing treatment for anyone that comes to the ED during a disaster; the facility is only requires to provide services within their capabilities. Under EMTALA, if an individual’s condition requires immediate stabilizing treatment and the hospital do not have the capability to stabilize the individual, then the individual should be appropriate transfer to another hospital for medical care. Transferring a patient because the hospital cannot provide stabilizing treatment is a violation of EMTALA (Gravely, Whaley, & Sanders 2007).
Received a call from an attorney asking for information about his client's husband. The attorney had called the SPD Branch and he was told they cannot share any information because the are prohibited by HIPAA Law. He was informed it is because the DHS workers are not allow to share information due to public assistance laws
HIPAA protects the information of each patient and requires strict confidentiality of the professional that work in a healthcare institution, medical office and anywhere where healthcare services are provided. “HIPAA considerations include the need to be able to provide the client, upon request, with a log of caregivers who have accessed his or her chart” (Hebda & Czar, 2013, p.288). In this case I consider that Kevin shouldn’t access his mother’s record unless he is authorized by her or the nurse in charge of her care that authorizes him to have access to it to write notes, orders and document each encounter with the patient. The clerks unit can access the patient chart if they are required to give information to authorize a procedure, study or a copy for study results or for labs, otherwise they either can’t access them. In Kaneesha is not right either for Kevin to be
For a large part of the end of the twentieth century, politicians have been trying to bridge the gap of providing healthcare services for everyone within the country. EMTALA provided the foundation to the expansion of the right to healthcare and put an end to discrimination based on the ability to pay for emergency healthcare services (Koeninger, 2013). In order to pay for emergent services for indigent patients, cost-sharing with the insured was established in order for hospitals and providers to recoup financial losses (Koeninger, 2013). Cost-sharing is one of the concepts utilized by the government for the financing of the ACA. By requiring all individuals to possess healthcare insurance, the cost for paying for
2 Points To Believe That 3-Parent-Babies Are Not The Way To Go; FDA Comments As Well
Our translational research has evaluated four chemotherapy agents with this research model. This disease-focused approach differs from that of a nurse or nurse practitioner. Working on clinical protocols has reinforced my appreciation of the role scientific investigation has on patient
The case consists of two major pharmaceutical companies that joint to collaborate their research and pharmaceutical technologies to start a joint venture in India. Both have valuable resources that have benefited both companies during the joint venture. Now both are questioning if there is still any value in maintaining the joint venture in India and will be deciding what will be the best route to take. Ranbaxy Laboratories wants to be bought out, but Eli Lilly is worried of the financial implications of such move.
The United States of America is arguably the greatest country in the history of the world. With this great global influence, one could assume the United States ensures the best for its citizens health and prosperity, to be a role model for the rest of the world. However, you would be greatly surprised. The United States is failing to take action against some of the major immoralities committed by its own bureaucracies, which consistently cause detrimental harm to the well-being of the American public. A significant bureaucracy that is responsible for a great deal of harm to the U.S. is the Food and Drug Administration, or FDA. The FDA is preventing the sustainability of the
As a Project Manager for FDA projects at White Oak, College Park, and MOD II, I was required to develop my clients’ needs assessment, confirm the agency needs, and from those needs, develop the SOW and IGCE for the project. Once the PR was submitted I was responsible to follow FAS requirements working with the Contracting Officer in obtaining proposals from contractors, contract negotiation and proposal acceptance. After the award I closely managed the day to day progress of the project. At completion of the project I collected lessons learned and compared them to previous projects and applied them to future projects. I was responsible for the quality of every aspect of the projects I
* Large Balance, $1.4B in goodwill on Merck’s Balance Sheet – the goodwill on Merck’s balance sheet is primarily attributable to past acquisitions.
For many types of cancers, we have been using the same base drug (first line treatment) for ten years or even longer. As companies find new drugs to fight the cancers, they hope that it will be the miracle drug that will eradicate the cancer, but it usually isn’t. When they reach this conclusion, instead of returning to the chalkboard and continuing to work to improve the drug, they put the drug on the market as is, and hope it will achieve something. Not only are they putting these drugs on the market but they put price tags on them that would bankrupt anyone without some sort of third party payer. The combination of all of these drugs make up what doctors