Regulatory Approval to Patient Access, an Evaluation of EU5 and us National Timing Differences.

نویسندگان

  • J Mycka
  • R Dellamano
  • W Lobb
  • N Dalal
  • E Pereira
  • L Dellamano
  • O Sagaydachnaya
چکیده

– Additional analysis of trends for products launched between April 2013 and May 2014 • New molecular entities, formulations and combinations approved by the EMA (EC centralized approval) between January 2009 and May 2014 were included in the analysis. FDA approval dates were retrieved. • Time comparison for general medicines vs. orphan and oncology indications was made including shifts over time • Drugs with time to market >1000 days were considered outliers and removed from the analysis • Timing differences were NOT weighted by the number of products not available by country and category OBJECTIVES & METHODS

برای دانلود رایگان متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

Biosimilars in the United States: Considerations for Oncology Advanced Practitioners

Biosimilars will enter the US market soon, potentially lowering costs and increasing patient access to important oncology biologics. Biosimilars are highly similar, but not identical, to their reference product. Subtle variations arise due to their inherent complexity and differences in manufacturing. Biosimilars are not generic drugs. They will be approved through a separate US regulatory path...

متن کامل

Regulatory and Biosafety Challenges for Vaccines

The global regulatory plan for vaccines provides a unique opportunity to develop safe and effective ones with assured quality. Methods used by regulators address challenges of new products and technologies and also increase understanding of benefits and risks of existing products. First, the laboratory-based regulatory sciences evolve correlates of immunity and safety; or improve the product ch...

متن کامل

New Health Technologies: A UK Perspective; Comment on “Providing Value to New Health Technology: The Early Contribution of Entrepreneurs, Investors, and Regulatory Agencies”

New health technologies require development and evaluation ahead of being incorporated into the patient care pathway. In light of the recent publication by Lehoux et al who discuss the role of entrepreneurs, investors and regulators in providing value to new health technologies, we summarise the processes involved in making new health technologies available for use in the United Kingdom.

متن کامل

Regional Incentives and Patient Cross-Border Mobility: Evidence from the Italian Experience

Background In recent years, accreditation of private hospitals followed by decentralisation of the Italian National Health Service (NHS) into 21 regional health systems has provided a good empirical ground for investigating the Tiebout principle of “voting with their feet”. We examine the infra-regional trade-off between greater patient choice (due to an increase in hospital services supply) an...

متن کامل

P-204: Evaluation of FMR1 Gene Regulatory Region for The Epigenetic Mark of H3K9 Acetylation in Blood Cells of Patients with Diminished Ovarian Reserve Reffered to Royan Institute

Background: Diminished ovarian reserve (DOR) is a heterogeneous disorder causing infertility, characterized by a decreased number of oocytes and high FSH level, the genetic cause of which is still unknown. The association between FMR1 premutations(50-200 CGG repeats) and the premature ovarian failure( POF) disease has suggested that FMR1 gene acts as a risk factor for POF and recently for DOR p...

متن کامل

ذخیره در منابع من

ذخیره در منابع من قبلا به منابع من ذحیره شده

{@ msg_add @}


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

عنوان ژورنال:
  • Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research

دوره 17 7  شماره 

صفحات  -

تاریخ انتشار 2014