While the world is going through pandemic turmoil and regulatory agencies are under immense stress to approve newer pharmaceutical therapies to market. However, the classical/regular clinical trial is a hefty process hence alternative provisions like speed trials were explored for the early entry of drugs for emergency usage.
This presentation is a brief overview of ICH-GCP guidelines. Although ICH-GCP is a very vast topic, still this presentation will cover almost all the points. The reader will be able to discuss about the roles and responsibilities of various personnel in clinical trials.
When a new drug/device/surgical procedure/treatment or other potential medical innovation is developed it must be thoroughly tested to ensure that it is safe and does what it is supposed to be.
This presentation will provide a basic overview of clinical research process.
This presentation is a brief overview of ICH-GCP guidelines. Although ICH-GCP is a very vast topic, still this presentation will cover almost all the points. The reader will be able to discuss about the roles and responsibilities of various personnel in clinical trials.
When a new drug/device/surgical procedure/treatment or other potential medical innovation is developed it must be thoroughly tested to ensure that it is safe and does what it is supposed to be.
This presentation will provide a basic overview of clinical research process.
An overview of ICH-GCP guidelines of clinical trials.
Good clinical practice (GCP): a standard for the design , conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.
ICH-GCP is an International Conference on Harmonization Good Clinical Practice.
The guideline was developed with consideration of the current good clinical practices of the European union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the world health organization
Roles and Responsibilities of sponsor, CRO, and investigator MOHAMMEDSALEEMJM
This slide mainly includes Roles and responsibilities of sponsor CRO and Investigator in Ethical conduct of Clinical Research as per ICH GCP Guidelines
Required mainly for Regulatory affairs students
“CSR is a detailed regulatory document which gives the information about the methods and results (related to efficacy and safety) of a clinical trial. CSRs are created as a part of the process of submitting applications to the Regulatory Authorities for new medical treatments and for its approval. CSRs can be full, abbreviated, synopsis, supplementary, observational etc as per the results and requirements”.
Amendments in Schedule Y in 2013,2014 inserted three new rules, new appendix XII: compensation in case of injury or death during clinical trial, amendments in ICD and appendix V inform consent form format.
INSTITUTIONAL REVIEW BOARD (IRB/IEC).pptxRAHUL PAL
The International Council on Harmonisation (ICH) defines an institutional review board (IRB) as a group formally designated to protect the rights, safety and well-being of humans involved in a clinical trial by reviewing all aspects of the trial and approving its startup. IRBs can also be called independent ethics committees (IECs).
An IRB/IEC reviews the appropriateness of the clinical trial protocol as well as the risks and benefits to study participants. It ensures that clinical trial participants are exposed to minimal risk in relation to any benefits that might result from the research.
IRB/IEC members should be collectively qualified to review the scientific, medical and ethical aspects of the trial.
Per the FDA, an IRB/IEC should have:
At least five members.
Members with varying backgrounds.
At least one member who represents a non-scientific area (a lay member).
At least one member who is not affiliated with the institution or the trial site (an independent member).
Competent members who are able to review and evaluate the science, medical aspects and ethics of the proposed trial.
conversion from INTRAVENOUS TO ORAL DOSING----- design of dosage regimenpavithra vinayak
conversion from INTRAVENOUS TO ORAL DOSING----- TYPES OF IV TO PO THERAPY CONVERSIONS: MEDICATIONS INCLUDED IN AN IV TO PO CONVERSION PROGRAM: SELECTION OF PATIENTS FOR IV TO PO THERAPY CONVERSION: design of dosage regimen--clinical pharmacokinetics and therapeutic drug monitoring-- fifth pharm D notes
An overview of ICH-GCP guidelines of clinical trials.
Good clinical practice (GCP): a standard for the design , conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.
ICH-GCP is an International Conference on Harmonization Good Clinical Practice.
The guideline was developed with consideration of the current good clinical practices of the European union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the world health organization
Roles and Responsibilities of sponsor, CRO, and investigator MOHAMMEDSALEEMJM
This slide mainly includes Roles and responsibilities of sponsor CRO and Investigator in Ethical conduct of Clinical Research as per ICH GCP Guidelines
Required mainly for Regulatory affairs students
“CSR is a detailed regulatory document which gives the information about the methods and results (related to efficacy and safety) of a clinical trial. CSRs are created as a part of the process of submitting applications to the Regulatory Authorities for new medical treatments and for its approval. CSRs can be full, abbreviated, synopsis, supplementary, observational etc as per the results and requirements”.
Amendments in Schedule Y in 2013,2014 inserted three new rules, new appendix XII: compensation in case of injury or death during clinical trial, amendments in ICD and appendix V inform consent form format.
INSTITUTIONAL REVIEW BOARD (IRB/IEC).pptxRAHUL PAL
The International Council on Harmonisation (ICH) defines an institutional review board (IRB) as a group formally designated to protect the rights, safety and well-being of humans involved in a clinical trial by reviewing all aspects of the trial and approving its startup. IRBs can also be called independent ethics committees (IECs).
An IRB/IEC reviews the appropriateness of the clinical trial protocol as well as the risks and benefits to study participants. It ensures that clinical trial participants are exposed to minimal risk in relation to any benefits that might result from the research.
IRB/IEC members should be collectively qualified to review the scientific, medical and ethical aspects of the trial.
Per the FDA, an IRB/IEC should have:
At least five members.
Members with varying backgrounds.
At least one member who represents a non-scientific area (a lay member).
At least one member who is not affiliated with the institution or the trial site (an independent member).
Competent members who are able to review and evaluate the science, medical aspects and ethics of the proposed trial.
conversion from INTRAVENOUS TO ORAL DOSING----- design of dosage regimenpavithra vinayak
conversion from INTRAVENOUS TO ORAL DOSING----- TYPES OF IV TO PO THERAPY CONVERSIONS: MEDICATIONS INCLUDED IN AN IV TO PO CONVERSION PROGRAM: SELECTION OF PATIENTS FOR IV TO PO THERAPY CONVERSION: design of dosage regimen--clinical pharmacokinetics and therapeutic drug monitoring-- fifth pharm D notes
Fast track Designation is a designation for accelerated approval of drugs and medicines in US. Presentation contains brief view of this expedite program.
Regulatory Compliance in Clinical Research: Navigating the FDA and Other Agen...ClinosolIndia
Regulatory compliance is a crucial aspect of conducting clinical research, ensuring that studies meet the requirements and standards set by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and other relevant bodies. Here are some key points to navigate regulatory compliance in clinical research:
Familiarize Yourself with Applicable Regulations: Stay updated on the relevant regulations and guidelines that govern clinical research, including FDA regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, and local regulatory requirements. Understand the specific regulations that apply to your study, such as those related to investigational new drugs (IND) or investigational device exemptions (IDE).
Obtain Institutional Review Board (IRB) Approval: IRBs play a crucial role in ensuring the protection of human subjects in research. Before initiating a clinical trial, obtain IRB approval by submitting a detailed study protocol, informed consent documents, and other required materials. IRBs review the study's scientific merit, ethical considerations, and compliance with regulations.
Investigational New Drug (IND) or Investigational Device Exemption (IDE) Application: If your clinical research involves the use of investigational drugs or devices, you may need to submit an IND or IDE application to the FDA. These applications provide detailed information on the investigational product, its safety, efficacy, manufacturing processes, and proposed study design.
Good Clinical Practice (GCP) Guidelines: GCP guidelines provide a framework for the conduct of clinical research to ensure data integrity and participant protection. Adhere to GCP principles, including informed consent, protocol adherence, accurate documentation, and appropriate monitoring and reporting of adverse events.
Adverse Event Reporting: Monitor and report adverse events occurring during the study promptly. Follow the FDA's requirements for safety reporting, including expedited reporting of serious and unexpected adverse events. Maintain accurate and complete records of adverse events and their follow-up actions.
Data Integrity and Documentation: Ensure the integrity, accuracy, and traceability of study data. Implement robust data management practices, including proper documentation, source data verification, and secure storage of study documents. Follow regulatory requirements for data retention, including archiving study records for the required period.
Audits and Inspections: Be prepared for audits and inspections by regulatory agencies. Maintain organized and easily accessible study documentation, including study protocols, informed consent forms, case report forms, and correspondence with IRBs and regulatory agencies. Cooperate with auditors or inspectors and address any identified deficiencies or findings promptly.
Chapter 19Clinical Trials Clinical TrialsThe history EstelaJeffery653
Chapter 19
Clinical Trials
Clinical Trials
“The history of the last 20 years is one of crises with drugs and medical devices, many approved despite the objections of the FDA’s own scientists.”
— Sidney M. Wolfe
Lecture Overview
Research and Development Investments Fund a Complex Multistage Pathway
Clinical Trials of Generic Drugs
Health Risk Assessments
Expanded Access Protocols
Termination of Clinical Trials
Observational Studies
International Clinical Trials
Informed Consent in General
Transparency and Full Disclosure in Clinical Testing
Financial Conflicts of Interest
Commitment to the Life Sciences
Source: Hammaker, D. K., & Knadig, T. M. with Tomlinson, S.J. (2017). Clinical trials. In Health care management and the law: Principles and applications (pp. 389-412). (2nd Ed.) Burlington, MA: Jones & Bartlett Learning.
Research and Development Investments Fund a Complex Multistage Pathway
Some major expenses are research materials, advanced computers, and other highly sophisticated machines that support research activities, and salaries of scientists. Stage specific activities include:
Drug discovery
Preclinical testing
Clinical trials
Approval by the FDA
Post marketing surveillance
Research and Development Investments Fund a Complex Multistage Pathway
Drug Discovery:
While most compounds will never be approved for use, each one is evaluated to determine its potential value compared to existing therapies, complexity of large scale manufacturing, and other factors.
Preclinical Testing:
Candidate drugs from the discovery stage receive 1 to 3 years of extensive testing to assess safety and show biological activity against a disease.
Chemical tests establish the purity, stability, and shelf life of a compound.
Manufacturing tests determine mass production of the drug.
Pharmaceutical development studies explore dosing, packaging, and formulation of the drug.
Research and Development Investments
Fund a Complex Multistage Pathway: Clinical Trials
For drugs in development, there are low odds of reaching the market.
While Phase I, II, and III of studies are taking place, research investigators are also conducting toxicity tests and other long-term safety evaluations, evaluating dosage forms, planning for mass production, designing packaging, and preparing the extensive application required for FDA approval.
One out of five drugs that enter clinical testing is never approved by the FDA:
20% of the drugs that enter Phase I are approved to enter Phase II
30% of the drugs that enter Phase II are approved to enter Phase III
60% of the drugs that enter Phase III are approved for a new drug application
80% of the new drug applications are approved by the FDA for market entry
Research and Development Investments Fund a Complex Multistage Pathway
Approval by the U.S. Food and Drug Administration
According to the FDA, the documentation required in a new drug application is supposed to tell the whole story of a ...
INTRODUCTION
IND TYPES
IND CATEGORIES
THE IND APPLICATION MUST CONTAIN INFORMATION IN THREE BROAD AREA
THE REGULATORY ENVIRONMENT AND FDA ROLE
LIST OF IMPORTANT SECTIONS
GENERAL PRINCIPLES
INVESTIGATIONAL NEW DRUG GUIDANCE AND PLANNING
FDA FORM 1571
FDA FORM 1572
FDA FORM 3674
SUBMITTING AN IND
FOLLOWING RECEIPT OF IND BY THE FDA
RESPONDING TO A CLINICAL HOLD
REGULATORY REQUIREMENTS FOR AN IND DURING STUDY AND AT COMPLETION
PROTOCOL AMENDMENTS (21 CFR 312.30)
INFORMATION AMENDMENTS (21 CFR 312.31)
SAFETY REPORTS (21 CFR 312.32)
ANNUAL REPORTS (21 CFR 312.33)
WITHDRAWAL, TERMINATION, AND INACTIVATION
MONITORING RESPONSIBILITIES FOR SPONSOR-INVESTIGATORS
Understanding the Drug Development ProcessEMMAIntl
The FDA’s process for drug development can be a lengthy, and often expensive, commitment. If you are developing a new drug product from the beginning, it is critical that you understand the phases of the development process and the deliverables for each. Beginning with R&D, you will have to ensure that your product corresponds with the FDA’s definition of a drug product. Next, it is advised that you conduct sufficient testing to get a baseline understanding of how your product works, what its intended use is, and other product specifications. Once you have completed this first step, you are ready to embark on the drug development journey...
The stages of Drug Discovery and Development processA M O L D E O R E
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug
Computational fluid dynamics (CFD) is a branch of fluid mechanics that uses numerical analysis and data structures to analyze and solve problems that involve fluid flows.
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
Biological screening of herbal drugs: Introduction and Need for
Phyto-Pharmacological Screening, New Strategies for evaluating
Natural Products, In vitro evaluation techniques for Antioxidants, Antimicrobial and Anticancer drugs. In vivo evaluation techniques
for Anti-inflammatory, Antiulcer, Anticancer, Wound healing, Antidiabetic, Hepatoprotective, Cardio protective, Diuretics and
Antifertility, Toxicity studies as per OECD guidelines
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
In this webinar you will learn how your organization can access TechSoup's wide variety of product discount and donation programs. From hardware to software, we'll give you a tour of the tools available to help your nonprofit with productivity, collaboration, financial management, donor tracking, security, and more.
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
Normal Labour/ Stages of Labour/ Mechanism of LabourWasim Ak
Normal labor is also termed spontaneous labor, defined as the natural physiological process through which the fetus, placenta, and membranes are expelled from the uterus through the birth canal at term (37 to 42 weeks
Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
A Strategic Approach: GenAI in EducationPeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
2. The drug research and development process is a marathon.
It takes an average of 12 years for a drug to progress from early laboratory discovery to approval for human
use (Figure 1). The FDA works to protect public health by balancing the requirements for extensive safety and
efficacy data prior to approval, and the need to expeditiously issue approval decisions to ensure medicines that
could save or dramatically improve patients’ lives are available as soon as possible.
It begin with concept of drug lead and getting different FDA approvals and steppig up to the
door from where the drug lead transformed into a New Drug that can be marketed.
And that needs pulling of million of dollar in the process.
Pharmaceutical organizations are faced with time and cost complexities throughout the
process, including Phase I through Phase IV clinical trials.
3. Reducing the time and cost of the R&D process as a whole, and of clinical trials in particular, is
of paramount importance. But why? Why we are so much concern to companies making money
from market.
The more companies must invest, the greater their financial exposure and risk. The longer
the process takes, the greater the odds the company making the investment loses its
competitive advantage. At a minimum, the window between product market introduction
and patent cliff is narrowed, limiting the revenue stream before other manufacturers can
enter with generics.
To Encourage!
The clinical trials experience may discourage industry players from achieving that noble objective.
4. They also have embraced a new business model. Rather than conducting the R&D
process in-house, pharmaceutical companies are teaming with external partners to
leverage their expertise and accelerate the process.
Clinical trials are a natural fit for the external partner business model, allowing
companies to take advantage of the strengths of contract research organizations,
laboratories, investigators, vendors, trial sites, and others.
5. Speeding the availability of drugs that treat serious diseases are in everyone's interest,
especially when the drugs are the first available treatment or if the drug has
advantages over existing treatments. The Food and Drug Administration has
developed four distinct and successful approaches to making such drugs available as
rapidly as possible:
• Priority Review
• Breakthrough Therapy
• Accelerated Approval
• Fast Track
6. ACCELERATED APPROVAL ALLOWS THE USE OF SURROGATE ENDPOINTS
In response to the AIDS crisis in the late 1980’s, the FDA drafted initiatives to accelerate drug delivery and cut costs for new
drugs treating serious and life-threatening illnesses and conditions, granting approval to drugs after extended Phase II trials. In
1992, in response to a push by AIDS advocates to make the investigational anti-AIDS drug azidothymidine (AZT) accessible,
the FDA enacted “Subpart H” commonly referred to as Accelerated Approval; giving rise to expedited review of drugs by the
FDA.
When studying a new drug, it can sometimes take many years to learn whether a drug actually provides
a real effect on how a patient survives, feels, or functions. A positive therapeutic effect that is clinically
meaningful in the context of a given disease is known as “clinical benefit”. Mindful of the fact that it may
take an extended period of time to measure a drug’s intended clinical benefit, in 1992 FDA instituted
the Accelerated Approval regulations. These regulations allowed drugs for serious conditions that filled
an unmet medical need to be approved based on a surrogate endpoint. Using a surrogate endpoint
enabled the FDA to approve these drugs faster.
Eg: For example, instead of having to wait to learn if a drug actually extends survival for cancer patients,
the FDA may approve a drug based on evidence that the drug shrinks tumors, because tumor shrinkage
is considered reasonably likely to predict a real clinical benefit. But to study weather shrinkage
correspond to longer life of patient the companies still needs to conduct phase 4 clincal trials.
7. A surrogate endpoint used for accelerated approval is a marker - a laboratory measurement,
radiographic image, physical sign or other measure that is thought to predict clinical benefit, but
is not itself a measure of clinical benefit. Likewise, an intermediate clinical endpoint is a
measure of a therapeutic effect that is considered reasonably likely to predict the clinical benefit
of a drug, such as an effect on irreversible morbidity and mortality (IMM).
8. Fast track is a process designed to facilitate the development, and expedite the review of drugs to
treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs
to the patient earlier.
Fast Track addresses a broad range of serious conditions.
Serious condition: whether the drug will have an impact on such factors as survival, day-to-day
functioning, or the likelihood that the condition, if left untreated, will progress from a less severe
condition to a more serious one. AIDS, Alzheimer’s, heart failure and cancer are obvious examples of
serious conditions.
However, diseases such as epilepsy, depression and diabetes are also considered to be serious
conditions
9. Any drug being developed to treat or prevent a condition with no current therapy obviously is directed
at an unmet need. If there are available therapies, a fast track drug must show some advantage over
available therapy
A drug that receives Fast Track designation is eligible for some or all of the following:
More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate
data needed to support drug approval
More frequent written communication from FDA about such things as the design of the proposed clinical trials
and use of biomarkers
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of its Biologic License
Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section
of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not
begin until the drug company has submitted the entire application to the FDA
10. Fast Track designation must be requested by the drug company. The request can be initiated at any
time during the drug development process. FDA will review the request and make a decision within
sixty days based on whether the drug fills an unmet medical need in a serious condition.
Once a drug receives Fast Track designation, early and frequent communication between the FDA
and a drug company is encouraged throughout the entire drug development and review process. The
frequency of communication assures that questions and issues are resolved quickly, often leading to
earlier drug approval and access by patients
The FDA Safety and Innovation Act (FDASIA) of 2012 amended the Fast Track designation to include the Generating
Antibiotics Incentives Now Act (GAIN Act), which provides incentives to help bring new antibiotics and other antimicrobials
to market.
Fast Track of Ebola Vaccines
11. FOR DRUGS WITH SUBSTANTIAL SUPERIORITY
Breakthrough Therapy designation is a process designed to expedite the development and review of
drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that
the drug may demonstrate substantial improvement over available therapy on a clinically significant
endpoint(s).
For purposes of Breakthrough Therapy designation, clinically significant endpoint generally refers to
an endpoint that measures an effect on irreversible morbidity or mortality (IMM) or on symptoms
that represent serious consequences of the disease.
12. clinically significant endpoint can also refer to findings that suggest an effect on IMM or serious
symptoms, including:
An effect on an established surrogate endpoint
An effect on a surrogate endpoint or intermediate clinical endpoint considered reasonably likely to predict a clinical
benefit (i.e., the accelerated approval standard)
An effect on a pharmacodynamic biomarker(s) that does not meet criteria for an acceptable surrogate endpoint, but
strongly suggests the potential for a clinically meaningful effect on the underlying disease
A significantly improved safety profile compared to available therapy (e.g., less dose-limiting toxicity for an oncology
agent), with evidence of similar efficacy
A drug that receives Breakthrough Therapy designation is eligible for the following:
• All Fast Track designation features
Intensive guidance on an efficient drug development program, beginning as early as Phase 1
Organizational commitment involving senior managers
13. PRIORITY REVIEW
SHORTENS FDA REVIEW TIMELINES
Prior to approval, each drug marketed in the United States must go through a detailed FDA
review process. In 1992, under the Prescription Drug User Act (PDUFA), FDA agreed to
specific goals for improving the drug review time and created a two-tiered system of review
times – Standard Review and Priority Review.
A Priority Review designation will direct overall attention and resources to the evaluation of
applications for drugs that, if approved, would be significant improvements in the safety or
effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared
to standard applications.
riority Review shortens the target period for FDA review from 10 months to 6 months, and this designation is often
used in combination with other expedited review processes.