Detalhe da pesquisa
1.
Meaningful Endpoints for Idiopathic Pulmonary Fibrosis (IPF) Clinical Trials: Emphasis on 'Feels, Functions, Survives'. Report of a Collaborative Discussion in a Symposium with Direct Engagement from Representatives of Patients, Investigators, the National Institutes of Health, a Patient Advocacy Organization, and a Regulatory Agency.
Am J Respir Crit Care Med
; 209(6): 647-669, 2024 Mar 15.
Artigo
em Inglês
| MEDLINE | ID: mdl-38174955
2.
The impact of FDA regulatory activities on incident dispensing of LABA-containing medication: 2005-2011.
J Asthma
; 55(8): 907-914, 2018 08.
Artigo
em Inglês
| MEDLINE | ID: mdl-28910559
3.
Changing patterns of asthma medication use related to US Food and Drug Administration long-acting ß2-agonist regulation from 2005-2011.
J Allergy Clin Immunol
; 137(3): 710-7, 2016 Mar.
Artigo
em Inglês
| MEDLINE | ID: mdl-26725997
4.
Inhaled Corticosteroids and LABAs - Removal of the FDA's Boxed Warning.
N Engl J Med
; 378(26): 2461-2463, 2018 Jun 28.
Artigo
em Inglês
| MEDLINE | ID: mdl-29949485
5.
Long-acting beta2-adrenergic agonist in pediatric and adolescent asthma patients, 2003-2011.
J Asthma
; 51(10): 1061-7, 2014 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-24945885
6.
Serious Neurologic Events after Epidural Glucocorticoid Injection--The FDA's Risk Assessment.
N Engl J Med
; 373(24): 2299-301, 2015 Dec 10.
Artigo
em Inglês
| MEDLINE | ID: mdl-26444582
7.
EXCELS study results do not rule out potential cancer risk with omalizumab.
J Allergy Clin Immunol
; 135(1): 289, 2015 Jan.
Artigo
em Inglês
| MEDLINE | ID: mdl-25441294
8.
A Boxed Warning for Montelukast: The FDA Perspective.
J Allergy Clin Immunol Pract
; 9(7): 2638-2641, 2021 07.
Artigo
em Inglês
| MEDLINE | ID: mdl-33744471
9.
Drug Interaction Between Febuxostat and Thiopurine Antimetabolites: A Review of the FDA Adverse Event Reporting System and Medical Literature.
Pharmacotherapy
; 40(2): 125-132, 2020 02.
Artigo
em Inglês
| MEDLINE | ID: mdl-31885095
10.
Assessing the safety of adding LABAs to inhaled corticosteroids for treating asthma.
N Engl J Med
; 364(26): 2473-5, 2011 Jun 30.
Artigo
em Inglês
| MEDLINE | ID: mdl-21714647
11.
The risks and benefits of indacaterol--the FDA's review.
N Engl J Med
; 365(24): 2247-9, 2011 Dec 15.
Artigo
em Inglês
| MEDLINE | ID: mdl-22168640
12.
A Novel Pharmacokinetic Bridging Strategy to Support a Change in the Route of Administration for Biologics.
J Pharm Sci
; 108(7): 2490-2499, 2019 07.
Artigo
em Inglês
| MEDLINE | ID: mdl-30871994
13.
The Effect of FDA Drug Safety Communications on Patterns of Tiotropium Dispensing: A U.S. Health Plan Claims Database Study.
J Manag Care Spec Pharm
; 24(7): 700-709, 2018 Jul.
Artigo
em Inglês
| MEDLINE | ID: mdl-29952703
14.
The US Food and Drug Administration's drug safety recommendations and long-acting beta2-agonist dispensing pattern changes in adult asthma patients: 2003-2012.
J Asthma Allergy
; 10: 67-74, 2017.
Artigo
em Inglês
| MEDLINE | ID: mdl-28356763
15.
Immunotherapy with a ragweed vaccine.
N Engl J Med
; 356(1): 86; author reply 87, 2007 Jan 04.
Artigo
em Inglês
| MEDLINE | ID: mdl-17202461
16.
Underscoring the Importance of Allopurinol in Treating Gout: Results of a Food and Drug Administration-Mandated Safety Trial.
Arthritis Rheumatol
; 72(6): 877-878, 2020 06.
Artigo
em Inglês
| MEDLINE | ID: mdl-32460423
17.
International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences.
AAPS J
; 17(3): 546-57, 2015 May.
Artigo
em Inglês
| MEDLINE | ID: mdl-25758352
18.
Evaluation of epinephrine's expiration date: A US Food and Drug Administration's perspective.
J Allergy Clin Immunol Pract
; 7(8): 2948, 2019.
Artigo
em Inglês
| MEDLINE | ID: mdl-31706500
19.
Comments on the Salmeterol Multicenter Asthma Research Trial.
Chest
; 130(3): 930-1; author reply 931, 2006 Sep.
Artigo
em Inglês
| MEDLINE | ID: mdl-16963702
20.
Proceedings from the American College of Rheumatology Reproductive Health Summit: the management of fertility, pregnancy, and lactation in women with autoimmune and systemic inflammatory diseases.
Arthritis Care Res (Hoboken)
; 67(3): 313-25, 2015 Mar.
Artigo
em Inglês
| MEDLINE | ID: mdl-25385050