Abstract:
:Despite more than a century of evolving federal legislation, there remain many unapproved drugs on the United States (US) market. This article reviews the history of drug approval in the US, beginning with the landmark Pure Food and Drug Act of 1906, through to the development of the US Food and Drug Administration (FDA). The Pure Food and Drug Act of 1906 was the first comprehensive federal legislation covering drug regulation. Intervening legislation, such as the Federal Food, Drug, and Cosmetic Act of 1938 and Kefauver-Harris Amendments in 1962, was later instituted. In June 2006, a century after the development of the FDA as an enforcement body, an initiative was undertaken to remove unapproved drugs from the marketplace. The Marketed Unapproved Drugs-Compliance Policy Guide outlines enforcement policies aimed at efficiently and rationally bringing all unapproved and illegally marketed drugs into the approval process, or discontinuing their manufacture, distribution, and sale. The FDA has been actively pursuing control of unapproved drugs in recent years, with an approach concentrating on drug safety to ensure optimal public health and consumer protection.
journal_name
Adv Therjournal_title
Advances in therapyauthors
Nasr A,Lauterio TJ,Davis MWdoi
10.1007/s12325-011-0059-4subject
Has Abstractpub_date
2011-10-01 00:00:00pages
842-56issue
10eissn
0741-238Xissn
1865-8652journal_volume
28pub_type
历史文章,杂志文章,评审abstract:INTRODUCTION:Advances in cystic fibrosis (CF) therapy have resulted in improved survival and increasing treatment burden and costs. The economic impact of current treatment strategies for CF is poorly defined. METHODS:The authors prospectively assessed direct medical costs (including hospitalizations, outpatient inter...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-013-0008-5
更新日期:2013-02-01 00:00:00
abstract::Atrial fibrillation (AF) and venous thromboembolism (VTE) are highly prevalent and relevant healthcare issues. Direct oral anticoagulants (DOACs) are now the first-choice for anticoagulant treatment of these conditions displaying a better efficacy/safety profile than vitamin-K antagonists, mainly due to significantly ...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-020-01307-z
更新日期:2020-05-01 00:00:00
abstract::X-linked hypophosphataemia (XLH) is the most prevalent form of hereditary rickets characterized by an alteration of phosphate metabolism which frequently leads to the appearance of fractures, bone deformities and growth delay. Although the mechanism of growth impairment in patients with XLH still needs to be clarified...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-019-01178-z
更新日期:2020-05-01 00:00:00
abstract::In the original article. The third author name is incorrect. The correct name is Nicholas J. Leeper. ...
journal_title:Advances in therapy
pub_type: 已发布勘误
doi:10.1007/s12325-020-01220-5
更新日期:2020-02-01 00:00:00
abstract::Some patients with interstitial lung diseases (ILDs) other than idiopathic pulmonary fibrosis exhibit a progressive clinical phenotype. These chronic progressive fibrosing ILDs have a variety of underlying diseases, and their prevalence is currently unknown. Here we carry out the first systematic review of literature ...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-020-01578-6
更新日期:2020-12-14 00:00:00
abstract::Nateglinide is an oral antidiabetic medication that acts through rapid, short-term stimulation of insulin production. This study was undertaken to identify the incidence and nature of adverse effects of nateglinide and to assess its efficacy in clinical practice. Patients (n = 3254) were recruited from 606 centers in ...
journal_title:Advances in therapy
pub_type: 杂志文章,多中心研究
doi:10.1007/BF02849871
更新日期:2005-09-01 00:00:00
abstract:INTRODUCTION:This retrospective study evaluates the efficacy of palliative chemotherapy with a modified docetaxel, cisplatin, 5-fluorouracil (5-FU; "TPF" regimen) regimen (mTPF; reduced doses of docetaxel, cisplatin, and 5-FU with reduction of intravenous 5-FU from 4 days to 2 days) in Asian patients with recurrent and...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-011-0085-2
更新日期:2012-01-01 00:00:00
abstract:INTRODUCTION:To date, no study has reported the prevalence of cannabis use in chronic pain patients. The aim of this study is to investigate the trends in cannabis use among chronic pain in-patients from 2011 to 2015 in the USA. METHODS:Patients were identified from the National Inpatient Sample (NIS) database using t...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-020-01416-9
更新日期:2020-08-01 00:00:00
abstract:INTRODUCTION:Transient hepatic attenuation differences (THAD) are areas of high parenchymal enhancement observed during the hepatic arterial phase on computed tomography (CT). THAD in the left lobe of the liver can lead to surgical complications. METHODS:A retrospective study was conducted on patients who underwent mu...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01428-5
更新日期:2020-09-01 00:00:00
abstract:INTRODUCTION:There is limited information published on switching erythropoiesis-stimulating agent (ESA) treatment for anemia associated with chronic kidney disease (CKD) from darbepoetin alfa (DA) to methoxy polyethylene glycol-epoetin beta (PEG-Epo) outside the protocol of interventional clinical studies. AFFIRM (Aran...
journal_title:Advances in therapy
pub_type: 杂志文章,多中心研究
doi:10.1007/s12325-013-0063-y
更新日期:2013-11-01 00:00:00
abstract::Patients with severe gastrointestinal motility disorders are often found to have intravenous access clots or deep venous thrombosis. It has previously been reported that many patients who have intravenous access thrombosis have concomitant thrombotic risk factors. In this study, the goal was to determine the underlyin...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/BF02850315
更新日期:2006-09-01 00:00:00
abstract:INTRODUCTION:Anti-vascular endothelial growth factor therapy is the standard of care for neovascular age-related macular degeneration (nAMD). The dosage of two licensed agents, ranibizumab and aflibercept, was established through clinical trials; however, it is unclear if either agent is administered as recommended in ...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-017-0624-6
更新日期:2017-12-01 00:00:00
abstract:INTRODUCTION:Arteriosclerosis obliterans (ASO) causes ischemic symptoms of the lower limbs, reducing quality of life (QOL), and has a poor prognosis. Early diagnosis and treatment are necessary. In this study, the effects of long-term administration of beraprost sodium (beraprost) to treat ASO were investigated. METHO...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-013-0030-7
更新日期:2013-05-01 00:00:00
abstract:INTRODUCTION:Synthesis of evidence on the long-term use of first-line biologic therapy in patients with early rheumatoid arthritis (RA) is required. We compared the efficacy of up to 5 years' treatment with first-line tumor necrosis factor inhibitors (TNFis) versus other treatment strategies in this population. METHOD...
journal_title:Advances in therapy
pub_type: 杂志文章,meta分析
doi:10.1007/s12325-018-0869-8
更新日期:2019-03-01 00:00:00
abstract::Subretinal hemorrhage secondary to age-related macular degeneration (AMD) has a poor visual prognosis. Surgical drainage of the blood improves visual acuity only in selected patients. We report on two elderly patients with spontaneous subretinal hemorrhage from AMD. In one eye, recombinant tissue plasminogen activator...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:
更新日期:1997-09-01 00:00:00
abstract::This multicenter, double-masked, randomized, parallel-group study compared the efficacy and safety of ketorolac tromethamine 0.5% ophthalmic solution with levocabastine 0.05% and ketorolac tromethamine vehicle in patients with seasonal allergic conjunctivitis. One drop of ketorolac, levocabastine, or vehicle was insti...
journal_title:Advances in therapy
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1007/BF02854842
更新日期:2000-03-01 00:00:00
abstract:INTRODUCTION:This analysis of pooled data from four randomized, controlled-dose adjustment, phase 3 studies (three 15-week, double-blind, placebo- and active-controlled studies and a 1-year, open-label, active-controlled safety study) in patients with chronic osteoarthritis hip or knee pain or low back pain evaluated t...
journal_title:Advances in therapy
pub_type: 杂志文章,meta分析
doi:10.1007/s12325-014-0128-6
更新日期:2014-06-01 00:00:00
abstract:INTRODUCTION:Our objective was to determine the effectiveness of a perindopril/indapamide (Per/Ind) single-pill combination (SPC) in a broad range of patient profiles, including subgroups with varying hypertension severity, age and cardiovascular risk profiles. METHODS:Patient data from four large prospective observat...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01527-3
更新日期:2020-11-05 00:00:00
abstract:INTRODUCTION:Clinical guidelines recommend levothyroxine as the standard of care for hypothyroidism and that patients should be treated with a consistent preparation of synthetic levothyroxine without switching among formulations. This study examines the likelihoods of negative clinical outcomes between continuous user...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01537-1
更新日期:2020-10-28 00:00:00
abstract:INTRODUCTION:To compare the 24-h intraocular pressure (IOP) control and tolerability of travoprost/timolol benzalkonium chloride (BAK)-free (TTFC) vs. latanoprost/timolol fixed combination preserved with BAK (LTFC) in open-angle glaucoma patients insufficiently controlled with latanoprost 0.005% monotherapy given once ...
journal_title:Advances in therapy
pub_type: 杂志文章,随机对照试验
doi:10.1007/s12325-014-0125-9
更新日期:2014-06-01 00:00:00
abstract:PURPOSE:To compare the efficacy of bromfenac 0.09% and dexamethasone 0.1% in the treatment of anterior chamber inflammation after uncomplicated cataract surgery. METHODS:Seventy-six patients with senile cataracts and no other ocular comorbidities who underwent uneventful phacoemulsification were randomized 1:1 to rece...
journal_title:Advances in therapy
pub_type: 杂志文章,随机对照试验
doi:10.1007/s12325-019-01076-4
更新日期:2019-10-01 00:00:00
abstract:OBJECTIVE:Examine outcomes and costs of patients with persistent asthma who initiated treatment with beclomethasone dipropionate hydrofluoroalkane (BDP-HFA) or fluticasone propionate (FP). METHODS:MedStat's Commercial Claims and Encounters database (July 1, 2002-June 30, 2007) was utilized. Patients (n=13,968) were in...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-009-0056-z
更新日期:2009-08-01 00:00:00
abstract:INTRODUCTION:Extraintestinal manifestations (EIMs) in patients with Crohn's disease (CD) are common and associated with additional morbidity. This study aimed to evaluate the effect of adalimumab therapy on EIM resolution and identify potential predictors of EIM resolution in adult and pediatric patients with moderate ...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-018-0678-0
更新日期:2018-04-01 00:00:00
abstract:INTRODUCTION:Most cases of small cell lung cancer (SCLC) are diagnosed at an advanced stage. The objective of this study was to investigate patient characteristics, survival, chemotherapy treatments, and health care use after a diagnosis of advanced SCLC in subjects enrolled in a health system network. METHODS:This wa...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-019-01161-8
更新日期:2020-01-01 00:00:00
abstract::Diabetic foot ulcers (DFUs) are one of the most common and serious complications of diabetes mellitus, as wound healing is impaired in the diabetic foot. Wound healing is a dynamic and complex biological process that can be divided into four partly overlapping phases: hemostasis, inflammation, proliferative and remode...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-014-0140-x
更新日期:2014-08-01 00:00:00
abstract:INTRODUCTION:Pulmonary arterial hypertension (PAH) is associated with poor prognosis despite significant recent advances in its treatment. An intravenous formulation of epoprostenol sodium containing glycine and mannitol (epoprostenol GM; GlaxoSmithKline, London, UK) is widely used to treat PAH. A new formulation of ep...
journal_title:Advances in therapy
pub_type: 杂志文章,多中心研究
doi:10.1007/s12325-013-0029-0
更新日期:2013-05-01 00:00:00
abstract:INTRODUCTION:Benefit and risk of anticoagulation in cirrhotic patients with portal vein thrombosis (PVT) remain controversial, especially in those with asymptomatic PVT and in non-liver transplant candidates. Furthermore, the predictors of portal vein recanalization and bleeding events after anticoagulation are critica...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01550-4
更新日期:2020-11-05 00:00:00
abstract::Nonketotic hyperosmolar coma (NHC) is characterized by severe hyperglycemia; absence of, or only slight ketosis; nonketotic acidosis; severe dehydration; depressed sensorium or frank coma; and various neurologic signs. This condition is uncommon in type 1 diabetes. Because of little or no osmotic diuresis in patients ...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/BF02849861
更新日期:2005-09-01 00:00:00
abstract::The prevalence of chronic airways diseases such as chronic obstructive pulmonary disease and asthma is increasing. They lead to symptoms such as a cough and shortness of breath, partially through bronchoconstriction. Inhaled anticholinergics are one of a number of treatments designed to treat bronchoconstriction in ai...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-009-0074-x
更新日期:2009-10-01 00:00:00
abstract::Retinal vein occlusions are common retinal vascular disorders with the potential for significant vision-related morbidity. Retinal vein occlusions are classified as either branch retinal vein occlusion (BRVO), central retinal vein occlusion (CRVO), or hemiretinal vein occlusion (HRVO) based on the specific occlusion s...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-010-0088-4
更新日期:2011-01-01 00:00:00