an analysis of warning letters issued by FDA to pharmaceutical manufacturers
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this ppt gives an insight on health outcomes claims in US & prescriptional drug promotional violations
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The partial pharmacoeconomic evaluations are cost analysis, cost-effectiveness analysis and cost-utility analysis. A comparison of costs and consequences of two alternatives is an example of a full pharmacoeconomic evaluation known as cost-benefit analysis. Therefore, the answer is not a.
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Similar to an analysis of warning letters issued by FDA to pharmaceutical manufacturers
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PHARMACOVIGILANCE COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated IN 202...Pristyn Research Solutions
Quick Job interview short guide For Pharma and all Life science jobseekers.All Medical | Biotech |Micro |B.Sc., M.Sc.
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What are the objectives of PV?
What is MedDRA?
WHAT ARE THE Role of Drug Safety
Associate?
What should narratives consist of?
What are Data assessments in PV?
Which products are covered by PV?
Methods of signal detection?
Why PV is required after clinical
trial?
What is an Adverse Drug Event (ADE)?
What
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for a valid case according to WHO?
When
do you consider an event to be
serious?
What do you mean by causality?
Types of
Unsolicited reports
Sources of Solicited Reports
Name the core regulatory bodies
What is Volume 9A
What do you know
about E2a, E2b and E2c guidelines?
When do you consider a case to be medically confirmed?
What is CemFlow?
What is the yellow card in PV?
What are Comorbid conditions?
What is a medication error?
What is a signal?
Rechallenge
Dechallenge
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Adverse Drug Reaction (ADR)
Effectiveness/risk
harm
Essential medicines
Frequency of ADRs
Individual Case Safety Report
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SolutionsClinical literature evaluation
This document discusses the importance of evaluating clinical literature and provides guidance on how to systematically approach literature evaluation. It describes how to identify the level and type of reference (tertiary, secondary, primary), and provides tips for evaluating different aspects of clinical studies, such as the objective, subjects, treatment administration, setting, methods, controls, and data analysis. The document also discusses how the FDA communicates important drug safety information to healthcare professionals and the public.
Post marketing servillence
This document discusses post-marketing surveillance (PMS), which involves monitoring the safety of pharmaceutical drugs after they have been approved and released on the market. PMS is important because pre-approval clinical trials involve relatively small groups of patients and may miss rare or long-term adverse effects only seen in larger populations. The document outlines various methods for PMS, including spontaneous reporting, cohort studies, and case-control studies. It also discusses the benefits of PMS for improving product quality and safety monitoring, as well as manufacturers' role in establishing PMS procedures and evaluating feedback.
Post marketing servillence
This document discusses post-marketing surveillance (PMS), which involves monitoring the safety of pharmaceutical drugs and medical devices after they have been approved and released on the market. PMS is important because pre-approval clinical trials involve limited numbers of patients and cannot detect all potential adverse effects. The document outlines the history of PMS, sources of PMS information, benefits of PMS systems, methods of surveillance including spontaneous reporting and cohort studies, and how manufacturers can establish PMS procedures and systems to gather feedback on their products.
3..Post marketing surveillance.pptx
This document discusses post marketing surveillance of drugs. It defines post marketing surveillance as monitoring drugs once they reach the market to evaluate their safety and efficacy in wider patient populations than clinical trials. Several methods of post marketing surveillance are described, including spontaneous reporting, cohort studies, and case control studies. The goals of post marketing surveillance include identifying unexpected side effects, assessing drug interactions, and ensuring safe use of medications. It is an important part of pharmacovigilance, the science of monitoring pharmaceutical safety and outcomes.
Directed Project
This document discusses regulatory inefficiencies surrounding companion diagnostics and laboratory developed tests (LDTs) in the United States. It uses the case study of Genentech's drug MPDL3280A and its companion diagnostic to show that the FDA thoroughly regulates companion diagnostics but provides no oversight of clinical validity for LDTs. This allows multiple competing diagnostic tests to be used without proof of efficacy. The document also compares healthcare systems and technology assessment processes in the US, UK, and France to illustrate decentralized decision making in the US compared to centralized bodies in other countries.
postmarketing surviellance,,outsourcing of BA ,BE , CRO.
This document provides an overview of post-marketing surveillance, outsourcing of bioavailability and bioequivalence studies to contract research organizations. It discusses the need for post-marketing surveillance to identify rare or long-term adverse drug reactions not seen in clinical trials. Methods for post-marketing surveillance include controlled trials, spontaneous reporting, cohort and case-control studies. Outsourcing bioavailability and bioequivalence studies to CROs can help reduce costs and improve resource efficiency for pharmaceutical companies.
Marketing and promotion_facts_071108_final
Pharmaceutical marketing aims to educate consumers and healthcare professionals about new treatments. While some question the value of marketing, it plays an important role in disseminating medical information. Recent changes include voluntary principles for direct-to-consumer ads and a strengthened industry code of ethics. Studies show marketing helps address underdiagnosis and undertreatment by raising disease awareness and prompting patients to see doctors. However, most physicians say clinical knowledge and patient needs strongly influence prescribing over marketing.
Marketing and promotion_facts_071108_final
Pharmaceutical marketing to healthcare providers provides information on new treatment options, but it is only one of many factors that influence prescribing decisions. Surveys find clinical knowledge, patient factors, and insurance policies have greater impacts. Approximately 67% of US prescriptions are for generic drugs, much higher than other countries. While representatives provide information, prescribing is shaped more by clinical guidelines, peers, formularies, and insurers' prior authorization requirements than representative interactions.
Fda Cms Summit Panel Preso In Ventiv
The document discusses challenges facing the healthcare industry and opportunities for collecting patient-reported outcomes data to inform coverage decisions. It notes the industry faces a "perfect storm" of healthcare reform uncertainties like expanding coverage and cost containment. Patient-reported outcomes data from registries, reimbursement programs, and adherence programs could provide evidence of effectiveness and be valuable to payers, but how and whether it will be used by decision-makers remains unclear. The document calls for developing more effective patient-reported outcomes instruments and engaging payers on how this data can be integrated into their coverage policies.
Benefits of print advertising and repeated exposures
This document discusses the importance of repeated exposure through print advertising in medical journals for keeping pharmaceutical brands top of mind for doctors. It summarizes several studies that show:
- Message recall is low, even with 4 exposures per year, requiring many more exposures for awareness.
- Frequency and consistency of advertising pay off, improving awareness the more a message is repeated.
- Print ads have a positive impact on doctors who prescribe the brand, whether or not they see a sales representative, and can influence prescribing behaviors.
- In a controlled study, 3 times as many doctors recalled a product they saw in print ads versus a control group who did not see ads.
POST MARKETING SURVILLANCE
This document discusses post-marketing surveillance of pharmaceuticals. Post-marketing surveillance involves monitoring drugs after they are approved for public use to identify safety risks. It can involve controlled clinical trials, spontaneous reporting of adverse events, cohort studies, and case-control studies. The FDA Adverse Event Reporting System collects over a million reports annually to detect unknown risks and safety issues not found in clinical trials. Post-marketing surveillance is important for monitoring long-term effects and risks in broader patient populations than clinical trials.
Kapal 2019-bashaw-final (nx power-lite copy)
Slides presented by me at the Korean-American Professional Association in Life Sciences (KAPAL) 5th Annual Meeting in Rockville, MD. Slides discuss the recent reorganization of the Center for Drug Evaluation and Research at the FDA
Final FDA guidance on Medical Devices and Risk Analysis
This document provides guidance for assessing benefits and risks when evaluating applications for investigational device exemptions (IDEs). It aims to clarify the factors considered by the FDA when making IDE approval decisions. The guidance emphasizes that effective risk management, including risk mitigation measures, can allow for a favorable benefit-risk determination. It also notes that earlier stages of device development are associated with greater uncertainty, but that uncertainty can be offset by risk controls. The guidance seeks to facilitate a balanced, comprehensive decision-making approach that considers clinical, nonclinical and patient perspectives.
Chapter 19Clinical Trials Clinical TrialsThe history
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 ...
Influence of pharmaceutical marketing on
1) The study examined the influence of pharmaceutical marketing strategies on the prescription practices of physicians in Bangladesh. It surveyed 500 physicians across various cities using a questionnaire.
2) The study found that marketing strategies like frequent visits from sales representatives, personal relationships between physicians and reps, product quality, and company reputation had the strongest influence on prescription decisions. Less effective strategies included gifts, advertising, and direct mailings.
3) Personal selling approaches like frequent visits and relationships had the most impact, while public relations efforts like sponsoring conferences and launch meetings also influenced physicians somewhat.
New Product Planning in the Pharmaceutical Industry
Lecture presented in the Competitive Intelligence and Pricing course as part of the University of Southern California Master of Science in Healthcare Decision Analysis program. Presented on June 14, 2020 at USC via Zoom. The lectures gives an overview of what new product planning is in the pharmaceutical industry, what tools are used during new product evaluations, and the key elements of a new product business case. The lecture includes a couple of case studies to be worked on by the class.
New Health Report 2012 - Media Briefing Deck
The document summarizes the key findings of the 2012 New Health Report survey conducted by Quintiles. The survey gathered responses from over 1,350 stakeholders in the biopharmaceutical industry, managed care organizations, investors, and patients in the US and UK. The report found that stakeholders have differing views on risk tolerance and perceptions of healthcare quality. It also found that current tools for assessing risk are limited and better data is needed. Overall, the report aims to foster collaboration between stakeholders to improve innovation in pharmaceutical development and delivery.
Similar to an analysis of warning letters issued by FDA to pharmaceutical manufacturers (20)
Post Marketing Clinical Research & Marketing Strategy
Post Marketing Clinical Research & Marketing Strategy
PHARMACOVIGILANCE COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated IN 202...
PHARMACOVIGILANCE COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated IN 202...
postmarketing surviellance,,outsourcing of BA ,BE , CRO.
postmarketing surviellance,,outsourcing of BA ,BE , CRO.
Benefits of print advertising and repeated exposures
Benefits of print advertising and repeated exposures
Final FDA guidance on Medical Devices and Risk Analysis
Final FDA guidance on Medical Devices and Risk Analysis
Chapter 19Clinical Trials Clinical TrialsThe history
Chapter 19Clinical Trials Clinical TrialsThe history
New Product Planning in the Pharmaceutical Industry
New Product Planning in the Pharmaceutical Industry
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Disclaimer: No one is perfect, so please mind that there might be mistakes and typos.
dtubbenhauer@gmail.com
Corrected slides: dtubbenhauer.com/talks.html
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aziz sancar nobel prize winner: from mardin to nobel
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an analysis of warning letters issued by FDA to pharmaceutical manufacturers
- 1. P.SAI SINDHU II/II M.PHARMACY REGULATORY AFFAIRS An analysis of the warning letters issued by the FDA to pharmaceutical manufacturers regarding misleading health outcomes claims
- 2. ABSTRACT To evaluate the number and type of warning letters issued by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers for promotional violations. The various promotional materials include print advertisements, broadcast advertisements, and visual aids which are commonly used by sales representatives
- 3. Introduction • The Division of Drug, Marketing, Advertising and Communications (DDMAC) is the unit within the FDA’s Center for Drug Evaluation and Research (CDER), which is concerned with the regulation of prescription drug promotion and oversees all the promotional activities. • the aim was to identify the primary focus of promotional claim violations in warning letters, whether it was clinical, quality of life, or economic.
- 4. METHODS 1 • http://www.fda.gov/cder/warn. 2 • Claims were classified based on the Economic, Clinical, and Humanistic Outcomes model, namely misleading economic, clinical, and QoL outcome claims. 3 • Each warning letter was reviewed by two individuals and entered into a database in Microsoft Excel. 4 • A third reviewer arbitrated any form of disagreement. Descriptive analysis was conducted using SAS
- 5. RESULTS & DISCUSSION Characteristics of misleading claims in warning letters issued by FDA Type of claim frequency Percentage of total claims Overstatement of efficacy or unsubstantiated efficacy claims 34 18.6 Comparison of clinical effectiveness/superiority claims 24 13.1 Unsubstantiated safety & tolerability claims 5 2.7 Broadening ofindication claims 25 13.7 Omission/minimization of risk information 56 30.6 Unsubstantiated Q.O.L claims 1 0.5 Misleading claims 2 1.1 Cost superiority claim 1 0.5
- 6. CONCLUSIONS Majority of the misleading claims were clinical in nature and contained promotional materials directed to physicians. Inadequate promotion of medications may lead to irrational prescribing. The current study emphasizes the importance of disseminating reliable, credible, and scientific information, to the target audience.
- 7. REFERENCES Center for Drug Evaluation and Research, Division of Drug, Marketing, Advertising and Communications. Description. Silver Spring, (MD): US FDA. http://www.fda.gov/AboutFDA/CentersOffices/CDE R/ucm090279.htm [Accessed November 2009] Jackson J. FDAMA 1997 Section 114: Another Look. Value Health.2009;12(2):1-2.