Výsledky vyhledávání - "Daniel W Sigelman"

Use of US Food and Drug Administration Expedited Drug Development and Review Programs by Orphan and Nonorphan Novel Drugs Approved From 2008 to 2021

Autor: Andrea N. Monge, Daniel W. Sigelman, Robert J. Temple, Harinder Singh Chahal

Publikováno v: JAMA network open. 5(11)

ImportanceThe US Food and Drug Administration (FDA) has 4 programs that can be used alone or in combination to expedite drug availability: Accelerated Approval, Breakthrough Therapy, Fast Track, and Priority Review. Drugs using these programs can inc

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::42bc84d99c48db3a3c94f364cb7724ce
https://pubmed.ncbi.nlm.nih.gov/36318213

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State Continuing Education Requirements for Physicians and Dentists, Including Requirements Related to Pain Management and Controlled Substance Prescribing

Autor: Daniel W Sigelman, Peter Lurie, Clydette Powell, Anna Gribble, Jing Xu

Publikováno v: Journal of Medical Regulation. 103:12-20

States often require prescribers to undergo continuing education (CE) activities in specific areas of public health concern. Such requirements are of particular interest in the context of the opioid epidemic. In this article, we describe the prevalen

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::ee5c4021a349ebeffdc22bad36f46db4
https://doi.org/10.30770/2572-1852-103.3.12

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Public Disclosure of the Filing of New Drug and Therapeutic Biologics Applications With the US Food and Drug Administration

Autor: Daniel W Sigelman, Peter Lurie, Anam H Chaudhry, Harinder Singh Chahal, Stella Kim, David Szeto

Publikováno v: JAMA Intern Med

This cross-sectional study reviews New Drug Applications for new molecular entities and Biologics License Applications for new and biosimilar biological products submitted to the US Food and Drug Administration to assess how frequently applicants dis

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::10872ee212c884b2aa3b513d88a7c926
https://pubmed.ncbi.nlm.nih.gov/31157824

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Contents of US Food and Drug Administration Refuse-to-File Letters for New Drug Applications and Efficacy Supplements and Their Public Disclosure by Applicants

Autor: Robert Temple, Harinder Singh Chahal, Sanjana Mukherjee, Daniel W Sigelman

Publikováno v: JAMA Internal Medicine. 181:522

Importance Before reviewing drug applications, the US Food and Drug Administration (FDA) conducts “filing reviews” to assess whether they are complete enough for full review. If the applications are incomplete, the FDA issues refuse-to-file (RTF)

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::09b592b0231dfdddd0d5dfd4ba57462c
https://doi.org/10.1001/jamainternmed.2020.8866

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Under-reporting of cardiovascular events in the rofecoxib Alzheimer disease studies

Autor: Jerry Avorn, Daniel W. Sigelman, James W. Mayer, David Madigan, Curt D. Furberg

Publikováno v: American Heart Journal. 164:186-193

Background In September 2004, rofecoxib (Vioxx) was removed from the market after it was found to produce a near doubling of cardiovascular thrombotic (CVT) events in a placebo-controlled study. Its manufacturer stated that this was the first clear e

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6c0f52a66c7fba66173ae240250c3794
https://doi.org/10.1016/j.ahj.2012.05.002

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Comparison of content of FDA letters not approving applications for new drugs and associated public announcements from sponsors: cross sectional study

Autor: Peter Lurie, Barbara Ddamulira, Daniel W Sigelman, Sylvie Stacy, Joshua Sclar, Harinder Singh Chahal

Publikováno v: The BMJ

Objectives To describe the content of non-public complete response letters issued by the US Food and Drug Administration (FDA) when they do not approve marketing applications from sponsors (drug companies) and to compare them with the content any sub

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ffa296df87d950a703a64baaeba903f5
https://doi.org/10.1136/bmj.h2758

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Palm-Reading the Invisible Hand: A Critical Examination of Pro-Competitive Reform Proposals

Autor: Daniel W. Sigelman

Publikováno v: Journal of Health Politics, Policy and Law. 6:578-620

The conviction that competition could discipline the medical marketplace more adequately than regulation is rapidly ascendant among Washington policymakers. This article assesses the effects of the competition strategy on those who currently have hea

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1b4240d0fe90c9acbe18a42bbe19f8df
https://doi.org/10.1215/03616878-6-4-578

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