Results 151 to 160 of about 4,177,143 (225)

Recent trends for drug lag in clinical development of oncology drugs in Japan: does the oncology drug lag still exist in Japan?

International Journal of Clinical Oncology, 2015
This study exhaustively and historically investigated the status of drug lag for oncology drugs approved in Japan.We comprehensively investigated oncology drugs approved in Japan between April 2001 and July 2014, using publicly available information.
Hideki, Maeda, Tatsuo, Kurokawa
openaire   +3 more sources

The Drug Lag: An Interpretive Review of the Literature

International Journal of Health Services, 1977
This article reviews the literature pertinent to the “drug lag” issue, in order to evaluate the evidence underlying the thesis that the U.S. has suffered from a slowdown in the rate and timing of new drug introductions, to the detriment of patients, because of the stricter requirements since 1962 regarding proof of safety and efficacy for new drugs ...
L G, Schifrin, J R, Tayan
openaire   +3 more sources

A Drug Lag Update

Drug Information Journal, 1995
Kenneth I. Kaitin, Jeffrey S. Brown
openaire   +2 more sources

Do Free Trade Agreements Matter to Drug Lag? Recent Evidence From Korea After the Korea–U.S. Free Trade Agreement

International Journal of Health Services, 2020
The KORUS FTA includes various clauses on marketing approval of new medicines and their reimbursement decisions. We aim to capture the availability of new medicines, to measure drug lags for new medicines, and to demonstrate the effect of the KORUS FTA ...
K. Son
semanticscholar   +1 more source

The Drug Lag

JAMA: The Journal of the American Medical Association, 1976
To the Editor.— In referring to propranolol and its indication for hypertension, Dr Crout states that the delay in consideration of the pending New Drug Application (NDA) resulted from the sponsor's not submitting the NDA until December 1974. That submission date is correct; however, if one examines the Food and Drug Administration's (FDA's) action ...
openaire   +2 more sources

Therapeutic Significance of the Drug Lag

Medical Care, 1980
This study evaluates the therapeutic significance of those drugs commercially available in foreign countries but not in the United States at the end of 1976. Of 198 drugs reviewed, 14% offered a potential therapeutic advance while 75% appeared to offer little or no advance. Another 10.5% could not be properly evaluated.
C E, Daniels, A I, Wertheimer
openaire   +2 more sources

An Empirical Analysis of Japan's Drug Development Lag Behind the United States

Journal of clinical pharmacology, 2021
The “drug lag” (ie, the approval lag for new drugs) hinders patients’ access to innovative new medicines. The drug lag was heavily debated in Japan from the late 2000s to the early 2010s.
Hiroshi Nakamura, N. Wakutsu, Satoshi Murayama, Takeshi Suzuki   +3 more
semanticscholar   +1 more source

Notable Differences in Drug Lag Between Korea and Japan of New Drugs Between 2009 and 2017.

Therapeutic Innovation and Regulatory Science, 2019
BACKGROUND Although great efforts have been made to address delays in new-drug approvals between different regions, little is known regarding drug lag in Korea.
Sang-Won Lee, So-Hee Park, I. Song, Yunha Noh, Hyekyung Park, Dongmun Ha, Ju-Young Shin   +6 more
semanticscholar   +1 more source

Comparison of Oncology Drug Lag in Japan and South Korea Based on the Interval between the U.S. Approval and the Local Approval.

Biological and Pharmaceutical Bulletin
Drug lag is a serious issue for patients with life-threatening diseases such as cancer. Japan and Korea have been facing a large drug lag, despite having a large market and a good clinical trial environment.
Yoshifumi Tachibana, Jangsoo Yoon, M. Narukawa   +2 more
semanticscholar   +1 more source

The Drug Lag—Does it Exist in Europe?

Drug Intelligence & Clinical Pharmacy, 1975
Paul de Haen
openaire   +3 more sources