Prescription for a Stronger FDA

2006 ◽  
Vol 19 (5) ◽  
pp. 295-296
Author(s):  
Roy Guharoy ◽  
Gregory Cwikla ◽  
Andrew Burgdorf ◽  
Madan Joshi
Keyword(s):  
Public Health ◽  
Life Cycle ◽  
Drug Product ◽  
Drug Approval ◽  
Postmarketing Surveillance ◽  
Institute Of Medicine ◽  
Approval Process ◽  
Staff Members ◽  
The U.S ◽  
Systemic Drug

Recently, an Institute of Medicine panel concluded that years of negligence, mismanagement, inadequate resources, infighting among staff members, and lack of a systemic drug approval and postmarketing surveillance process have diluted the effectiveness of the Food and Drug Administration (FDA) in protecting public health. The panel was commissioned by the FDA to assess the U.S. drug safety system, and they recommended 25 sweeping changes, most of which would require congressional authorization. The recommendations focus on the life cycle of a drug product, rather than just the approval process, and they would go a long way in protecting public health in the future.

Regulatory requirements and comparison in approval of new and generic drugs in United States of America and Japan:-Implication for Future strategies

2020 ◽  
Vol 07 ◽  
Author(s):  
Paramjeet Malik ◽  
Neelam Pawar ◽  
Kavita Bahmani
Keyword(s):  
Generic Drugs ◽  
Drug Product ◽  
Drug Approval ◽  
Approval Process ◽  
Regulatory Requirements ◽  
Team Members ◽  
Regulatory Authorities ◽  
Effective Manner ◽  
Review Team

: Safety, efficacy and quality of a therapeutic product is the major concern for the pharmaceutical companies. FDA and PMDA are the main regulatory authorities in USA & JAPAN respectively that ensures the maintenance of these required parameters by forming standard guidelines and process for drug approval. These regulatory authorities’ reviews each step of a pharmaceutical drug product from its discovery phase to marketed product. Dossier plays an important role during the approval process of a drug product, as it allows both applicant and review team members to evaluate the data in an effective manner. A dossier consists of five modules containing informative data of various stages of a drug product but in a brief pattern with folders and subfolders. In the present paper, the authors focus on in-depth review of approval process for new and generic drugs in USA and Japan.

scholarly journals A review on drug approval process in US, Europe and India-dossier, bioavailability and bioequivalence studies

2017 ◽  
Vol 1 (04) ◽  
pp. 133-146
Author(s):  
Krishna Madagoni ◽  
Uppunuri Saidireddy ◽  
Himaja .
Keyword(s):  
Drug Product ◽  
Drug Approval ◽  
Approval Process ◽  
Technical Documentation ◽  
Regulatory Requirements ◽  
Regulatory Decision ◽  
New Drug ◽  
Regulatory Affairs ◽  
Regulatory Approach ◽  
Drug Approval Process

Pharmaceutical Regulatory Affairs (PRA) is a vital unit in a pharmaceutical company that successfully drives the Research and Development (RandD) efforts of the company to the market. In the present scenario, countries have different regulatory requirements for approval of a new drug. The single regulatory approach for marketing authorization application (MAA) of a new drug product applicable to various countries (on the basis of single dossier) is utmost difficult. Therefore, the knowledge of exact and detailed regulatory requirements for MAA of each country should be known to establish a suitable regulatory strategy. CTD was developed with the aim to provide a common format for the technical documentation that would significantly reduce the time and resources needed to compile applications for registration of human pharmaceuticals and would ease the preparation of electronic submissions. Bioavailability and bioequivalence testing are essential in the drug development process as they create the foundation for regulatory decision making when evaluating formulation changes and lot-to-lot consistency in innovator products. They also serve as the primary components to demonstrate therapeutic equivalence between generic products and the reference innovator product. This article will focus the similarities and differences in drug approval process and requirements of the documents/CTD specifications to the drug regulatory authorities in the Europe, USA and India also focuses on submission and work flow related to bioavailability and bioequivalence studies.

Surveillance for Bloodborne Infections

1999 ◽  
Vol 82 (08) ◽  
pp. 494-499 ◽  
Author(s):  
Mary Chamberland
Keyword(s):  
Public Health ◽  
Public Health Practice ◽  
Emerging Infectious Diseases ◽  
Blood Substitute ◽  
Surveillance Systems ◽  
Institute Of Medicine ◽  
Blood Safety ◽  
Prevention Strategies ◽  
Public Health Response ◽  
The U.S

IntroductionSince blood is a biological product, it is a natural vehicle for transmission of infectious agents, and until an artificial blood substitute is developed, the risk of transfusion-transmitted infections will probably not be eliminated. Three agencies of the Department of Health and Human Services–the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and National Institutes of Health (NIH)–have collaborated with partners in local and state public health departments, academia, industry, and consumers to develop prevention strategies addressing emerging infectious disease threats to public health, including the safety of the U.S. blood supply. Four critical components of these prevention strategies are as follows: surveillance and response capabilities; integration of laboratory science and epidemiology (i.e., “applied research”) to optimize public health practice; prevention and control activities to enhance communication of public health information; and a strengthening of local, state, and federal infrastructures to support these activities.1 As highlighted by the Institute of Medicine, in its series of reports about the ongoing threat to health posed by emerging infectious diseases, surveillance is the critical lynchpin for the public health response to both known and unrecognized pathogenic threats.2 Surveillance data can be used to monitor and track temporal and demographic trends of disease, alert us to outbreaks or unexpected alterations in disease frequency or affected populations, serve as a basis for subsequent epidemiologic and laboratory investigations to describe the natural history of a disease or identify risk factors for its occurrence, and evaluate intervention strategies.2,3 This paper will review programs of surveillance in the U.S. to detect established and emerging infectious risks, with an emphasis on those that address blood safety. In addition, recent examples or case studies that illustrate the responsiveness of U.S. surveillance systems to blood safety issues will be presented.

The Drug Approval Process and the Information it Provides

1987 ◽  
Vol 21 (10) ◽  
pp. 821-826 ◽  
Author(s):  
Ann Myers ◽  
Steven R. Moore ◽  
Abraham G. Hartzema ◽  
Miquel S. Porta ◽  
Hugh H. Tilson
Keyword(s):  
Drug Administration ◽  
Drug Approval ◽  
Specific Information ◽  
Approval Process ◽  
The Public ◽  
New Drug ◽  
Drug Approval Process ◽  
Organizational Procedures ◽  
Abbreviated New Drug Applications ◽  
The U.S

By law, the commissioner of the Food and Drug Administration (FDA) is responsible for determining whether a new drug is safe and efficacious before it is approved for marketing in the U.S. and for monitoring its use after approval. This paper provides a brief overview of the approval process, in terms of responsibilities of the sponsor in submitting an application for review to the FDA and FDA's responsibilities and organizational procedures for reviewing and approving those applications. A brief history on the legislation regarding the FDA's responsibility in the drug approval area is discussed along with recent regulations, legislation, and FDA initiatives aimed at improving the drug approval process. Specific information that can be released to the public upon request is also discussed. This paper is limited to the regulation of drugs; somewhat different regulations govern the review and regulation of biological products and abbreviated new drug applications.

scholarly journals A REVIEW ON DRUG APPROVAL PROCESS FOR US, EUROPE AND INDIA

2014 ◽  
Vol 2 (1) ◽  
pp. 1-11 ◽  
Author(s):  
Vishal Prajapati ◽  
Rahulgiri Goswami ◽  
Pratik Makvana ◽  
Jitendra Kumar Badjatya
Keyword(s):  
Drug Product ◽  
Research Work ◽  
Drug Approval ◽  
Research Data ◽  
Regulatory Agencies ◽  
Approval Process ◽  
The Public ◽  
New Drug ◽  
The World ◽  
Drug Approval Process

Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This article focuses on drug approval process in different countries like USA, Europe and India. 

scholarly journals An overview on comparative study of registration requirements for generics in US, Canada and Europe

2020 ◽  
Vol 1 (4) ◽  
pp. 117-123
Author(s):  
Suryawanshi Meghraj ◽  
Jain minal
Keyword(s):  
Generic Drug ◽  
Drug Product ◽  
Drug Approval ◽  
Approval Process ◽  
Regulatory Requirements ◽  
Technical Requirements ◽  
Generic Drug Product ◽  
Similarities And Differences ◽  
Drug Approval Process ◽  
Country Specific

Generic Drug Product approval is most stringent and crucial process for company with different rules and regulation in different country. For the registration of the product company has to follow regulatory rules and requirement of country specific agency. Company should apply product marketing authorization as per norms of country requirements and should manage life cycle of that product throughout market. Need to understand and describe the various regulatory requirements for the generic drug approval process and comparison of regulated country. To understand the technical requirements required to market medicines in regulated pharmaceutical market. To evaluate similarities and differences within regulated market of U.S, Canada, and Europe. To understand and evaluate differences of post approval Changes within regulated market.

EPEGENTIC TOXICOLOGY: PERSPECTIVES OF THE DEVELOPMENT

2018 ◽  
pp. 2-7
Author(s):  
G. A. Sofronov ◽  
E. L. Patkin
Keyword(s):  
Public Health ◽  
Life Cycle ◽  
Human Health ◽  
Chronic Exposure ◽  
Environmental Pollutants ◽  
Epigenetic Mechanisms ◽  
Epigenetic Changes ◽  
Mechanism Of Formation ◽  
Health Disorders ◽  
Time Periods

One of the complex problems of modern experimental toxicology remains the molecular mechanism of formation of human health disorders separated at different time periods from acute or chronic exposure to toxic environmental pollutants (ecotoxicants). Identifying and understanding what epigenetic changes are induced by the environment, and how they can lead to unfavorable outcome, are vital for protecting public health. Therefore, we consider it important a modern understanding of epigenetic mechanisms involved in the life cycle of mammals and assess available data on the environmentally caused epigenetic toxicity and, accordingly fledging epigenenomic (epigenetic) regulatory toxicology.

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