Página 1 dos resultados de 581 itens digitais encontrados em 0.065 segundos

‣ Price, Performance, and the FDA Approval Process: The Example of Home HIV Testing

Paltiel, A. David; Pollack, Harold A.
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Português
Relevância na Pesquisa
38.292217%
The Food and Drug Administration (FDA) is considering approval of an over-the-counter, rapid HIV test for home use. To support its decision, the FDA seeks evidence of the test’s performance. It has asked the manufacturer to conduct field studies of the test’s sensitivity and specificity when employed by untrained users. In this paper, we argue that additional information should be sought to evaluate the prevalence of undetected HIV in the end-user population. Our analytic framework produces the elementary but counterintuitive finding that the performance of the home HIV test – measured in terms of its ability to correctly detect the presence and absence of HIV infection among the people who purchase it – depends critically on the manufacturer’s retail price. This finding has profound implications for the FDA’s approval process.

‣ FDA Drug Approval Summary: Bevacizumab plus Interferon for Advanced Renal Cell Carcinoma

Summers, Jeff; Cohen, Martin H.; Keegan, Patricia; Pazdur, Richard
Fonte: AlphaMed Press Publicador: AlphaMed Press
Tipo: Artigo de Revista Científica
Português
Relevância na Pesquisa
48.0862%
This report describes the clinical trial results that led to the U.S. FDA approval of bevacizumab in combination with interferon for the treatment of renal cell carcinoma.

‣ U.S. Food and Drug Administration Approval: Rituximab in Combination with Fludarabine and Cyclophosphamide for the Treatment of Patients with Chronic Lymphocytic Leukemia

Casak, Sandra J.; Lemery, Steven J.; Shen, Yuan Li; Rothmann, Mark D.; Khandelwal, Aakanksha; Zhao, Hong; Davis, Gina; Jarral, Vaishali; Keegan, Patricia; Pazdur, Richard
Fonte: AlphaMed Press Publicador: AlphaMed Press
Tipo: Artigo de Revista Científica
Português
Relevância na Pesquisa
48.292217%
The purpose of this study was to describe the clinical studies that led to the FDA approval of rituximab in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with chronic lymphocytic leukemia (CLL). On the basis of the demonstration of clinically meaningful prolongation of PFS, the FDA granted regular approval to rituximab in combination with FC for the treatment of patients with CLL. The magnitude of the treatment effect in patients 70 years and older is uncertain.

‣ The FDA Review Process for Cardiac Medical Devices in Children: A Review for the Clinician

Almond, Christopher S.
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Português
Relevância na Pesquisa
38.418684%
Pediatric medical devices play a vital role in the treatment of children with cardiovascular disease. Most cardiac medical devices used in children today are used off-label where the risk-benefit of devices has not been well characterized. Pediatric medical devices face a variety of challenges to FDA approval related in large part to the small target population, heterogeneity of the patient population and ethical considerations of device testing in children. While relatively few cardiac devices have received FDA approval in children, the number of devices navigating the approval process successfully is growing. Most pediatric device approvals are being granted through the humanitarian device exemption (HDE) pathway, which is designed for rare diseases making it suitable for devices treating congenital heart disease. This review summarizes the FDA review process for pediatric medical devices as it continues to evolve in response to the unique challenges of understanding device performance in the pediatric population.

‣ FDA Approval Summary: Sunitinib for the Treatment of Progressive Well-Differentiated Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors

Blumenthal, Gideon M.; Cortazar, Patricia; Zhang, Jenny J.; Tang, Shenghui; Sridhara, Rajeshwari; Murgo, Anthony; Justice, Robert; Pazdur, Richard
Fonte: AlphaMed Press Publicador: AlphaMed Press
Tipo: Artigo de Revista Científica
Português
Relevância na Pesquisa
47.88069%
Results of a phase III randomized trial that led to approval by the U.S. Food and Drug Administration of sunitinib for the treatment of patients with progressive well-differentiated neuroendocrine tumors are presented.

‣ Understanding FDA Regulatory Requirements for an Investigational Device Exemption (IDE) for Sponsor-Investigators

Blair Holbein, M. E.; Berglund, Jelena Petrovic
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Publicado em /10/2012 Português
Relevância na Pesquisa
38.443608%
Clinical investigators in academic medical centers often perceive federal regulations as a significant obstacle to conducting clinical research. The regulatory authority of the FDA extends to clinical studies of medical devices. Consequently, researchers wishing to conduct device research using FDA-approved as well as non-approved devices must comply with federal regulations for Investigational Device Exemptions (IDE) as described in Title 21 of the Code of Federal Regulations Part 812. FDA regulatory oversight is structured to match the risk to the subject to the risk of the device. Medical device studies can be categorized as 1) meeting exemption criteria, 2) being a non-significant risk device, or 3) being a significant risk device. All IDE studies must meet regulations for the protection of human subjects, but no additional federal filing on the part of the investigator is necessary for those that meet exempt criteria. Non-significant risk device studies require meeting abbreviated IDE regulatory requirements for the conduct of the study, but no prior FDA approval is required. Significant risk device studies require that the investigator also function as a sponsor and to file an IDE with the FDA for approval before starting. A Sponsor-Investigator filing an IDE follows the format and content described in 21 CFR 812.20. The study may begin 30 days after the date of submission receipt unless the FDA notifies the sponsor otherwise. While the IDE is active...

‣ Could FDA approval of pre-exposure prophylaxis make a difference? A qualitative study of PrEP acceptability and FDA perceptions among men who have sex with men

Underhill, Kristen; Morrow, Kathleen M.; Operario, Don; Mayer, Kenneth H.
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Publicado em /02/2014 Português
Relevância na Pesquisa
48.92452%
The FDA has approved tenofovir-emtricitabine for use as HIV pre-exposure prophylaxis, but it is unknown how approval may affect PrEP acceptability among US men who have sex with men. We conducted 8 focus groups among 38 Rhode Island MSM, including 3 groups among 16 male sex workers and 5 groups among 22 men in the general MSM community. Participants reported wide-ranging beliefs regarding consequences and meanings of FDA approval. Some participants would not use PrEP without approval, while others perceived approval as irrelevant or less significant than other sources of information. Our results suggest that FDA approval sends a signal that directly shapes PrEP acceptability among some MSM, while indirect influences of approval may affect uptake by others. Efforts to educate MSM about PrEP can increase acceptability by incorporating information about FDA approval, and outreach strategies should consider how this information may factor into personal decisions about PrEP use.

‣ Will the Requirement by the US FDA to Simultaneously Co-Develop Companion Diagnostics (CDx) Delay the Approval of Receptor Tyrosine Kinase Inhibitors for RTK-Rearranged (ROS1-, RET-, AXL-, PDGFR-α-, NTRK1-) Non-Small Cell Lung Cancer Globally?

Ou, Sai-Hong Ignatius; Soo, Ross A.; Kubo, Akihito; Kawaguchi, Tomoya; Ahn, Myung-Ju
Fonte: Frontiers Media S.A. Publicador: Frontiers Media S.A.
Tipo: Artigo de Revista Científica
Publicado em 01/04/2014 Português
Relevância na Pesquisa
39.045308%
The discovery of anaplastic lymphoma kinase (ALK) rearrangement in non-small cell lung cancer (NSCLC) in 2007 and the approval of crizotinib for the treatment of advanced ALK-rearranged NSCLC in 2011 represents a landmark in the development of targeted oncology therapy. The approval of crizotinib was accompanied simultaneously by the approval of the Vysis (Abbott Molecular) break-apart fluorescence in situ hybridization (FISH) test as the companion diagnostic (CDx) test to detect ALK rearrangement. Pfizer, the manufacturer of crizotinib, sponsored the screening of thousands of patients and the standardization of the ALK FISH test as part of the approval process for crizotinib, a first in class ALK inhibitor. Many pharmaceutical companies are now using the Food and Drug Administration (FDA)-approved ALK FISH assay to enroll patients onto trials for their own respective ALK inhibitors. In essence they are “piggybacking” on the FDA-approved ALK FISH assay without having to pay for the development of a CDx, nor screening for ALK-rearranged NSCLC patients in the protocols because screening for ALK rearrangement is now the standard of care in NSCLC after the approval of crizotinib. Since 2007, rearrangement in more receptor tyrosine kinases (RTKs) such as ROS1...

‣ Proteomic cancer biomarkers from discovery to approval: it’s worth the effort

Li, Danni; Chan, Daniel W
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Publicado em /04/2014 Português
Relevância na Pesquisa
38.292217%
The current landscape of cancer biomarkers is changing rapidly, with new and exciting developments. With the advances of proteomic technologies, many potential cancer biomarkers have been discovered. However, the number of new cancer biomarkers cleared or approved by the US FDA is rather limited. Although technological advances are important, clearly defining intended use, good study design and appropriate patient specimens are critical for the success of FDA approval. While obtaining FDA clearance/approval for newly developed and clinically useful cancer biomarkers has been slow, the reward for patient care could be enormous.

‣ FDA Approval Summary: Crizotinib for the Treatment of Metastatic Non-Small Cell Lung Cancer With Anaplastic Lymphoma Kinase Rearrangements

Kazandjian, Dickran; Blumenthal, Gideon M.; Chen, Huan-Yu; He, Kun; Patel, Mona; Justice, Robert; Keegan, Patricia; Pazdur, Richard
Fonte: AlphaMed Press Publicador: AlphaMed Press
Tipo: Artigo de Revista Científica
Português
Relevância na Pesquisa
47.88069%
This paper outlines the U.S. Food and Drug Administration review of A8081007, a randomized trial comparing crizotinib and the standard of care (docetaxel or pemetrexed) in 347 patients with ALK-positive advanced non-small cell lung cancer who had previously received one platinum-containing regimen. This trial was submitted to confirm the clinical benefit of crizotinib and to support conversion to regular approval.

‣ Learning from Prozac: A Case Study on Reforming the FDA Drug Approval Process

Wood, Maria
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
Português
Relevância na Pesquisa
48.213486%
The law, focused as it is on making final determinations and settling issues one way or another, continually lags behind science, which concentrates on an evolving understanding of various phenomena through constant enhancement of current understandings of existing realities. Thus, a drug approval process, which obviously deals with scientific issues of drug development, cannot always keep pace with scientific understandings of drug development. The law is flexible and capable of accommodating new understandings, though; therefore, consideration of the scientific issues involved in drug development and approval is appropriate and ought to be undertaken as much as possible in order to develop legal answers that are as accurate as they can be at any given time.

‣ Post-Approval Testing By Pharmaceutical Manufacturers

Cave, Neil G.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
Português
Relevância na Pesquisa
38.418994%
A pharmaceutical manufacturer currently has an incentive to remain ignorant about a drug’s side effects after the Food and Drug Administration (“FDAâ€) approves the drug for marketing. Any new information the manufacturer produces by post-approval testing can lead to tort liability or withdrawal of FDA approval. Furthermore, ignorance can be a defense to liability because a patient injured by a drug will be unable to recover damages unless testing data is available to prove that the drug caused their particular injury. In theory, this ignorance incentive can be eliminated by imposing liability for failure to test a drug. Punitive damages would be essential to counterbalance lack of enforcement, because the lack of testing will prevent some patients from successfully bringing suit for failure to test. However in practice, few courts uphold punitive damages for a failure to test. The need for punitive damages can be reduced by implementing specific immunity to liability. Following completion of a conclusive test, a pharmaceutical manufacturer should be immune to liability for injuries that are the subject of that test. This specific immunity will broaden the incentive for post-approval drug testing...

‣ Adopting the Therapeutic Orphan: An Examination of FDA and Congress: Efforts to Promote the Inclusion of Children in Clinical Drug Studies

Patterson, Staci E.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
Português
Relevância na Pesquisa
48.212666%
This paper examines both the Food and Drug Administration’s Final Rule, which mandates drug sponsors to conduct pediatric research on their products prior to FDA approval and Section 111 of the Food and Drug Modernization Act, which provides economic incentives for drug sponsors to include children in research studies on their products. This paper concludes that Congress should renew the pediatric exclusivity provision of the Food and Drug Modernization Act, but with modifications as to provide incentives to drug sponsors for testing products on children that are not as burdensome to the elderly and the poor. After a historical review of the ills of pediatric testing, the paper discusses the need for more studies to be conducted regarding the effects of drugs commonly prescribed in children. The paper then discusses the need for regulation in clinical trials involving children. Next, the paper discusses past efforts of Congress and the FDA to encourage drug sponsors to include the pediatric population in research trials before marketing their products and then examines the latest efforts of both to encourage such studies. In the final section, the paper proposes modifications to FDAMA Section 111 to ensure that the legislation is meeting its goal of including children in more clinical trials in efforts to provide more labeling information in therapies used on children.

‣ Disclosure of the Dealings Between Drug Developing Companies and the FDA Under the Federal Securities Laws

Heinonen, Mikko
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
Português
Relevância na Pesquisa
38.545464%
The purpose of this article is to highlight the main issues raised by the Food and Drug Administration’s (“FDAâ€) approval process relating to new drugs and the treatment of this process receives in the context of the Federal Securities Laws . The partial inspiration for this article has been the recent highly publicized case concerning ImClone Systems Incorporated – a case, which well exemplifies both the connection between the valuation of a biotech/medical company and the FDA’s approval process for new drugs, and also the huge effect of the approval process to the market’s valuation of the stock price.

‣ Is the FDA Sexist? Sex and the Drug Approval Process

Petrovic, Emily S.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
Português
Relevância na Pesquisa
38.504878%
This paper examines the role of sex in the drug approval process. Medical literature has explored in great depth the many ways in which men and women differ, sometimes dramatically, often in ways that are seemingly unrelated to the physical, anatomical distinctions between the two sexes. After years of intentionally excluding women from critical phases of clinical drug trials, the FDA formally reversed such policies in the 1990s. A number of prescription drugs recently removed from the market disproportionately harmed women as compared to men. Loopholes in the current system have perpetuated the drug approval process’s inadequate consideration for the needs of women, thereby subjecting them to a higher level of risk. Efforts to correct for the lack of drug trials aimed to ensure the safety and efficacy for pediatric patients are also reviewed to provide a contrast. While the intentional biases in the system have been addressed, the current drug approval process fails to provide women with the same degree of protection as it does men. A number of issues remain requiring additional study and consideration before a complete solution can be proposed.

‣ Expediting Oncology Drug Approvals: The Public Backlash Against the FDA and Opportunities to Reform

Sung, Andrew J.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
Português
Relevância na Pesquisa
38.631135%
The FDA has made great strides over the past twenty years in loosening drug approval regulations to speed important, life-saving treatments to market. However, recent controversies involving anti-depressants for children and the withdrawal of two popular arthritis drugs and a multiple sclerosis therapy have created fears within the cancer community that the FDA will revert to a more cautious, conservative approval policy. Although cancer patient advocates have legitimate concerns about the pendulum swinging back to a more conservative agency stance, the FDA and the Oncologic Drugs Advisory Committee (ODAC) do not appear to have embraced a more risk-averse philosophy. Instead, the public backlash against the FDA presents the agency with an excellent opportunity to facilitate improvements to the accelerated approval and fast-track regulations for the benefit of cancer patients.

‣ FDA Drug Approval: A Black and White Issue?

Yonker, Stephanie A.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
Português
Relevância na Pesquisa
38.924314%
The FDA should judiciously limit the FDA approval of race-specific drugs to situations in which the utilization of racial categories is based on statistically significant scientific data and necessity and, in such cases, the meaning of race utilized should be defined. The term “race†is an inherently ambiguous social construct making the FDA approval of race-specific drugs and use of race in FDA approval decisions dangerous with debatable scientific legitimacy. Further, race is generally used in drug trials as a crude proxy for the determination of genetic variation, which tends to be both over and under-inclusive in determining the efficacy or safety of a drug for any individual. The limited genetic validity of race is confounded by the reality that many population differences between races may be the result of socio-economic and environmental factors that are not per se innate or inherent to any racial population. While the scientific validity of race as biologically significant classification is debatable, the general public is likely to interpret the governmental approval of the drug by the FDA as evidence of inherent genetic differences between racial groups that will serve to only further racial discrimination and eugenic ideologies. Thus...

‣ The Coming Collision of Ethics and the FDA: The Looming Problem of Cognitive Enhancement

Pine, Steven
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
Português
Relevância na Pesquisa
38.56623%
The current FDA process is not well suited for the introduction of enhancement drugs that are intended to improve certain aspects of cognition or behavior to a degree beyond what is normal. Even though there are no statutory restrictions against approving these drugs, the current positioning of the FDA approval process suggests these types of drugs would have a difficult time receiving approval for an indication that covers normal, healthy adults. However, until now the FDA has not had to confront this issue directly, since despite common media hype there is little scientific evidence that any drugs are true cognitive enhancers. That said, scientific interest in this area is growing, as is the pace of understanding about the framework of the brain. It seems only a matter of time before potently effective cognitive enhancements are developed. Once this happens, the current FDA norm of approval for a specific indication, followed by large off-label use, could result in many important ethical and safety questions going unaddressed. Ultimately, if the FDA is going to satisfy its mission to “promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner...

‣ REFORMING DRUG APPROVAL IN THE UNITED STATES: MEASURES NECESSARY TO ALLEVIATE THE CASH CRUNCH FACED BY SMALL BIOTECHNOLOGY COMPANIES

McWilliams, Douglas E.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
Português
Relevância na Pesquisa
48.75648%
Over the past decade, the infant biotechnology industry, led by small biotechnology companies, has produced numerous breakthrough drugs which have saved lives, reduced suffering and cut the cost of health care. Given that the biopharmaceutical industry has only been in existence for a little over 20 years, biotechnology holds enormous potential for the advancement of medical treatments. Unfortunately, even with biotechnology, as with the more traditional methods of drug development, the government mandated testing and approval of new therapeutic products takes a considerable amount of time and costs an exorbitant amount of money. The United States has the most demanding drug approval process in the world. Under the current Food and Drug Administration's drug approval process, the time required to gain approval for new drugs averages between 10 to 12 years and the cost approximates $350 million. In addition, the Food and Drug Administration (FDA) has come under attack as taking too conservative of an approach to approving beneficial new drugs. The purpose of this paper is to analyze the effects of this costly drug approval process on small biotechnology companies, to determine the effects of a decline in small biotechnology companies on the United States and to analyze current proposals to change the current Food and Drug Administration's drug approval process to ensure the survival of small biotechnology companies. Part II of this paper identifies the various stages of the drug approval process. Part III explores the policy behind the FDA's extensive drug approval process. Part IV examines the adverse affects of the drug approval process on small biotechnology companies. Part V analyzes the effect of a declining biotechnology industry on the United States. Part VI addresses current proposals to change the FDA drug approval process focusing on their ability to help small biotechnology companies.

‣ Essays on the pharmaceutical industry

Chen, Xiaobo
Fonte: University of Delaware Publicador: University of Delaware
Tipo: Tese de Doutorado
Português
Relevância na Pesquisa
38.74027%
Arnold, Michael A.; Essay 1: Strategic buying to keep competition in the market. I introduce a two-period dynamic model where a retailer transacts with two firms which produce a homogeneous product with different marginal costs. In this model, the firm with higher marginal cost would exit the market if price is below marginal cost. If the weak firm exits, the buyer faces a monopolist in the second period. To prevent this outcome, the buyer may intentionally purchase from the weak firm to keep it in the market. This behavior is called strategic buying. I analyze the conditions under which strategic buying will occur and responses of each firm to this strategic buying. Essay 2: Empirical study: the effects of announcements during the drug approval process on the stock valuation of the corresponding pharmaceutical firms. The purpose of this essay is to investigate which announcements during the new drug approval process impact the valuation of the related pharmaceutical company's stock using an event-study method over the period from 2004 to 2011. The results reveal extension of FDA review deadline, issuance of a complete response letter from the FDA, and approval of the first-time generics have negative influence on the stock price; public disclosure of advisory committee recommendation and approval of a new drug have significant positive impact on the related firm's stock returns; submission of a new drug application (NDA)...