New Drug Legislation: A Response From the Pharmaceutical Industry

1990 ◽  
Vol 9 (3) ◽  
pp. 110-113
Author(s):  
Paul E. Freiman
Keyword(s):  
Pharmaceutical Industry ◽  
Drug Legislation ◽  
New Drug

Business versus science: High drug prices conspire against oncological research.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e14580-e14580
Author(s):  
Felipe G. Gercovich ◽  
Ernesto Gil Deza ◽  
Eduardo L. Morgenfeld ◽  
Marcelo Muino ◽  
Marvin Albert Mizrahi ◽  
...  
Keyword(s):  
Pharmaceutical Industry ◽  
Drug Approval ◽  
Point Of View ◽  
New Drugs ◽  
New Drug ◽  
Drug Registration ◽  
Ethical Point ◽  
Post Marketing ◽  
State Of Affairs ◽  
Drug Approval Process

e14580 Background: It has been consistently proven that pivotal clinical trials (PCT) for drug registration or new drug indications (NDI), sponsored by the pharmaceutical industry, obtain better results than independent confirmatory studies (ICS). The interplay between PCT and ICS has supported better treatment selections and more realistic expectations: hope vs hype.The aim of this paper is to analyze the amount of ICS publications in Oncology within the last decade. Methods: All new FDA approved oncological drugs or NDI for solid tumors between 2005 and 2017 were taken into account. The PCT that led to their approval were identified, and between October and November 2019 a thorough search for related ICS (published or ongoing) was conducted on MEDLINE, ASCO Abstracts, NEJM, Lancet Oncology, JAMA, JCO, Cancer, PLOS ONE, PLOS Medicine and www.Clinicaltrials.gov. Results: Fifty-five new drugs or NDI were analyzed (Abemaciclib, Abiraterone, Ado-trastuzumab emtasine, Afatinib, Alectinib, Atezolizumab, Avelumab, Axitinib, Bendamustine, Bevacizumab, Brigatinib, Cabozantinib, Ceritinib, Cobimetinib, Crizotinib, Dabrafenib, Degarelix, Denosumab, Durvalumab, Eribuline mesylate, Everolimus, Ipilimumab, Irinotecan liposome, Ixabepilone, Lapatinib, Lenvatinib, Necitumumab, Neratinib, Nilotinib, Niraparib, Nivolumab, Olaparib, Osimertinib, Paclitaxel protein bound, Palbociclib, Panitumumab, Pazopanib, Pembrolizumab, Pertuzumab, Ramucirumab, Regorafenib, Ribociclib, Rucaparib, SipuleucelT, Sonidegib, Sorafenib, Sunitinib, Topotecan, Trabectedin, Trametinib, Trastuzumab, Vandetanib, Vemurafenib, Vismodegib, Ziv-afilbercept). Until November 30, 2019, no published or ongoing ICS were found in any of the cases. Conclusions: a) For the past decade, none of the PCT used for approval of new oncological drugs or NDI were replicated by ICS (without pharmaceutical industry sponsorship). b) We ignore the reasons for these approval methods but they raise suspicion and unnecessary discomfort. c) From an ethical point of view, patients’ Informed Consent must specify that expected results for the new drug or NDI are based exclusively on trials sponsored by the selling pharmaceutical company, unless other ICS are published. d) The current state of affairs can only be reverted if regulatory agencies and the scientific community demand ICS as part of the drug approval process or post-marketing duties.

scholarly journals Hot-melt extrusion in the pharmaceutical industry: toward filing a new drug application

2019 ◽  
Vol 24 (9) ◽  
pp. 1749-1768 ◽  
Author(s):  
Marta F. Simões ◽  
Rui M.A. Pinto ◽  
Sérgio Simões
Keyword(s):  
Pharmaceutical Industry ◽  
Drug Application ◽  
Hot Melt Extrusion ◽  
Melt Extrusion ◽  
New Drug ◽  
New Drug Application ◽  
Hot Melt

Current Issues Surrounding Women and Minorities in Drug Trials

1993 ◽  
Vol 27 (7-8) ◽  
pp. 904-911 ◽  
Author(s):  
Daniel P. Wermeling ◽  
Ada Sue Selwitz
Keyword(s):  
Clinical Trials ◽  
Pharmaceutical Industry ◽  
Clinical Research ◽  
New Drugs ◽  
Ethical Principles ◽  
Investigational Drug ◽  
Federal Regulations ◽  
Drug Trials ◽  
New Drug ◽  
Research Risks

OBJECTIVE: Our principal objective is to make readers aware of conflicting demands placed on investigators and the pharmaceutical industry regarding inclusion of women and minorities in clinical research. Tremendous pressures have been placed to expedite the drug approval process. Moreover, during the last decade certain segments of society, particularly women and minorities, have demanded greater participation in clinical drug trials and earlier access to investigational drug therapies. Regulations that have served the clinical research community (pharmaceutical industry, investigators, institutional review boards) as guidelines for safe conduct of human clinical trials are being challenged by social and political change. This article provides an overview of some of the controversy relative to federal regulations governing clinical trials; scientific concerns; social, political and legal trends; and ethical principles applied to human clinical research. DATA SOURCES: Literature for this paper was retrieved from a variety of sources including the nonmedical press, editorials, peer-reviewed journals, Department of Health and Human Services regulations, National Institutes of Health policy, the Belmont Report, and regulations of the Food and Drug Administration. DATA SYNTHESIS: Scientists evaluating new therapeutic agents ask specific research questions to assess safety, efficacy, and the mechanism(s) of action. Because of concerns for scientific validity, safety, liability, and convenience, many early evaluations of new drugs involve patient populations that may not represent the ultimate users of a new drug. Federal regulations and ethical principles allow certain groups of people to be excluded from early research proposals because they are thought to be putting themselves at greater risk by participating than are other groups. However, women, minorities, and other populations are demanding greater access to investigational drugs. The focus has changed from protection from research risks and burdens to the potential benefits a person or class of people may obtain by participating in a study. CONCLUSIONS: Scientists, the pharmaceutical industry, regulators, and society must agree on a safe and efficient mechanism for new drug development that permits more equitable participation of subjects in the various phases of research.

scholarly journals Regulatory compliances in development of commercial scale process of Nanoparticles (Liposomes and Niosomes) in pharmaceutical industry : A review

2020 ◽  
Vol 11 (4) ◽  
pp. 7094-7101
Author(s):  
Daka Nagarjuna Reddy ◽  
Mahaveer Singh ◽  
Birendra Shrivastava ◽  
Ravi Kumar Konda
Keyword(s):  
Pharmaceutical Industry ◽  
Review Process ◽  
Indian Market ◽  
Regulatory Requirements ◽  
New Drug ◽  
Industry Study ◽  
Review Study ◽  
Critical Overview ◽  
Abbreviated New Drug Applications ◽  
Regulatory Landscape

The main objective of this review work was designed to explore the regulatory environments that govern the pharmaceutical industry. Main objective of regulatory department is to maintain the quality, safety and efficacy of the medical products it also ensures the standard of medicinal product for sales, importing and manufacturing. The biggest challenge faced by the pharma manufactures is Scaling up their production. Our review process focuses on regulatory requirements concerning Liposomes and Niosomes and their limitations in respect to industrial applicability. In detail explanation of what type of information should be submitted to FDA and EU in new drug applications (NDAs) or abbreviated new drug applications (ANDAs). By comparing these two developed regulatory markets we can build a strong regulation in Indian market on Liposomes and Niosomes. The review study deals with the sound knowledge about regulatory landscape that governs the pharmaceutical industry. Study describes in depth about liposomes and niosomes delivery systems and gives a critical overview of the current regulatory landscape surrounding commercialization efforts of higher-level complexity systems, the expected requirements and the hurdles faced by companies seeking to bring novel liposome and noisome based systems for clinical use to market.

scholarly journals The Effect of Price Regulation on Innovation in the Pharmaceutical Industry

2011 ◽  
Vol 18 (4) ◽  
Author(s):  
Jennifer L. Troyer ◽  
Alexander V. Krasnikov
Keyword(s):  
Pharmaceutical Industry ◽  
Opportunity Cost ◽  
Empirical Relationship ◽  
Price Regulation ◽  
Drug Benefit ◽  
Empirical Results ◽  
New Drug ◽  
Hidden Cost ◽  
Drug Approvals ◽  
The Impact

The empirical relationship between pharmaceutical industry revenues and pharmaceutical industry innova- tion is estimated, allowing for an exploration of the impact of the Medicaid rebate program, a form of price regulation. Using the empirical results, the opportunity cost of the Medicaid rebate program is found to be as high as four new drug approvals annually. Given the increased interest in a Medicare drug benefit, regu- lators should be aware of the hidden cost of price regulation for pharmaceuticals.

Information Technology & FDA Compliance in the Pharmaceutical Industry

2011 ◽  
pp. 262-273
Author(s):  
Raymond Papp
Keyword(s):  
Information Technology ◽  
Pharmaceutical Industry ◽  
Food And Drug Administration ◽  
Drug Application ◽  
Over The Counter ◽  
Electronic Submission ◽  
Current Process ◽  
New Drug ◽  
Corporate Goals ◽  
New Drug Application

Given the recent profitability of and demand for pharmaceuticals, from prescription antibiotics and analgesics like Ciproflaxin and OxyContin and mens health drugs such as Viagra and Vardenafil to over-the-counter Senokot laxatives and Betadine antiseptics, the rush to develop and market new pharmaceuticals has never been greater. The current process is complex and it often takes several years for a drug to reach the market due to the myriad of Food and Drug Administration (FDA) guidelines. Furthermore, the recent FDA guidelines mandating that all New Drug Applications (NDA) be submitted in electronic (paperless) format by the end of 2002 is a catalyst for change in the pharmaceutical industry (FDA Proposes First Requirement for Electronic Submission, 2002; New Drug Application (NDA), 2001). Bayer Pharmaceutical, like its competitors Purdue Pharma and Boots Healthcare, has begun to take steps to assure that its use of information technology will allow it to not only meet FDA guidelines, but achieve its corporate goals of improved efficiency and reduced operating costs.

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