Results 141 to 150 of about 4,177,143 (225)

Generating Timely Estimates of Overdose Deaths for the US Using Urine Drug Test Data.

JAMA Netw Open
Myers JV, Marks C, Kim J, Fareed N, Thomas N, Whitley P, Fernandez S.   +6 more
europepmc   +1 more source

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Influence of Drug Lag on New Drug Label Revisions

Therapeutic Innovation & Regulatory Science, 2019
Drug lag (DL) in Japan has decreased in the last few years as a result of the globalization of drug development in the past decade, and new molecule entities (NMEs) with short DL are on the rise. The purpose of this study was to investigate the influence of DL on postmarketing safety of NMEs, by comparing the length of DL and the chronological trend of
Chikara Kikuchi, Miyako Murakami, Hitoshi Shimomura, Shuji Shimada, Takao Aoyama   +4 more
openaire   +3 more sources

The New Drug Lag: EU Lags in Review Times of Monoclonal Antibodies

Therapeutic Innovation & Regulatory Science, 2019
FDA had been criticized for its slow review of new drugs. Critics complained of a "drug lag" from which US patients suffered when compared to Europeans. Since the advent of PDUFA, however, the FDA has demonstrated a possible slight advantage in review time when compared to the EMA.Submission and approval dates for monoclonal antibodies were collected ...
Vibha, Sharma, Vivek Dasharath, Deore, Sandhya Vivek, Deore, Irwin G, Martin   +3 more
openaire   +3 more sources

The notorious “drug lag” for oncology drugs in Japan

Investigational New Drugs, 2011
This study aimed to analyze the oncology "drug lag" (i.e., the delay in time required for the approval of oncology drugs) in Japan compared with that in the United States of America (US) or the European Union (EU) and to identify the factors associated with this lag. Using publicly available information, we collected data on 42 approvals of 30 oncology
Kan, Yonemori, Akihiro, Hirakawa, Masashi, Ando, Taizo, Hirata, Mayu, Yunokawa, Chikako, Shimizu, Noriyuki, Katsumata, Kenji, Tamura, Yasuhiro, Fujiwara   +8 more
openaire   +3 more sources

Therapeutic implications of the drug lag

Clinical Pharmacology & Therapeutics, 1974
The American lag with respect to Britain in the introduction of new therapeutic drugs over the past decade was analyzed to determine whether, in therapeutic terms, Britain has gained or lost from adopting the more permissive policy. The therapeutic impact of a new drug on the whole community is difficult to assess, mainly because there are few methods ...
W. Wardell
openaire   +3 more sources

Analysis of Pediatric Drug Approval Lag in Japan

Therapeutic Innovation & Regulatory Science, 2020
Drugs should be made available to all patients in a timely manner regardless of whether they are adults or children. In contrast to the United States (US) and the European Union (EU), no laws mandating pediatric drug development have been established in Japan.
Eiji Ueyama, Masayuki Kaneko, Mamoru Narukawa   +2 more
openaire   +3 more sources

Who has a drug lag?

Managerial and Decision Economics, 1989
AbstractArrival time lags in twelve countries have been compared and the following conclusions drawn. Compared with the other countries in the sample population the USA does not have a drug lag. Alternative candidates are Australia, Norway and Japan. There are indications that arrival time lags decline over time.
John Parker
openaire   +2 more sources