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PubMed Journals Articles About "Pfizer Score Approval Orthopedic Drug" RSS

12:22 EST 10th December 2018 | BioPortfolio

Pfizer Score Approval Orthopedic Drug PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Pfizer Score Approval Orthopedic Drug articles that have been published worldwide.

More Information about "Pfizer Score Approval Orthopedic Drug" on BioPortfolio

We have published hundreds of Pfizer Score Approval Orthopedic Drug news stories on BioPortfolio along with dozens of Pfizer Score Approval Orthopedic Drug Clinical Trials and PubMed Articles about Pfizer Score Approval Orthopedic Drug for you to read. In addition to the medical data, news and clinical trials, BioPortfolio also has a large collection of Pfizer Score Approval Orthopedic Drug Companies in our database. You can also find out about relevant Pfizer Score Approval Orthopedic Drug Drugs and Medications on this site too.

Showing "Pfizer Score Approval Orthopedic Drug" PubMed Articles 1–25 of 12,000+

First granted example of novel FDA trial design under Expedited Access Pathway for premarket approval: BeAT-HF.

The Food and Drug Administration (FDA) initiated the Expedited Access Pathway (EAP) to accelerate approval of novel therapies targeting unmet needs for life-threatening conditions. EAP allows for the possibility of initial FDA approval using intermediate end points with postapproval demonstration of improved outcomes.


Proposed study designs for approval based on a surrogate endpoint and a post-marketing confirmatory study under FDA's accelerated approval regulations for disease modifying osteoarthritis drugs.

In 1992, the Food and Drug Administration (FDA) instituted the accelerated approval regulations that allow drugs or biologics for serious conditions that fill an unmet medical need to be approved on the basis of a surrogate endpoint or an intermediate clinical endpoint. The current definition of a serious condition includes chronic disabling conditions, such as osteoarthritis (OA), and thereby provides expanded opportunities for the use of biomarkers for regulatory approval of drugs for OA. The use of surro...

Is the pharmaceutical industry's preoccupation with the monotherapy drug model stifling the development of effective new drug therapies?

Drug discovery and development is heavily biased towards the development of monotherapies. Screening, testing, and evaluation of mono-entity drugs are generally much simpler than drug combinations, and are generally easier to get approval from the regulatory authorities for their clinical use. However, monotherapy drugs may not have optimal activity, may have associated toxicities, or may lose activity over time as their target develops resistance. Drug combinations, often developed from existing monotherap...


Identification of Factors Associated with First-Cycle Drug Approval Rates and Regulatory Outcomes for New Drug Applications.

The aims of this study were to identify types of deficiencies resulting in delay of approvals for drugs eventually approved by the US FDA and to search for factors associated with higher first-cycle approval rates. Review documents of New Drug Applications approved between 2008 and 2017 were retrieved from the Drugs@FDA database. Basic characteristics of the applications, regulatory actions, and reasons for non-approvals and/or major amendments after first review cycle were investigated. Of 825 applications...

Generalized fixed drug eruption to piperacillin/tazobactam and review of literature.

Fixed drug eruption (FDE) is an adverse drug reaction characterized by the development of well-circumscribed, round, dusky erythematous macules and plaques on cutaneous or mucosal surfaces. The reaction occurs on the same mucosal or cutaneous site with subsequent exposures to the offending drug. Although FDE usually manifests as a single lesion, in rare instances, more than one lesion may arise and this is referred to as a generalized eruption. Herein, we present a 31year-old man with history of cystic fibr...

Decreased survival and increased rate of fibrotic progression in essential thrombocythemia chronicled after the FDA approval date of anagrelide.

First-line cytoreductive drug of choice in high risk essential thrombocythemia (ET) is currently hydroxyurea, a practice based on the results of a randomized study; second-line drugs of choice include pegylated interferon-α, busulfan and anagrelide. Anagrelide clinical trials were pioneered by the late Murray N. Silverstein (1928-1998) of the Mayo Clinic whose studies led to FDA approval in March 1997. The current study represents a retrospective examination of the potential impact of anagrelide therapy on...

The Correlation Between PROMIS Pain Interference and VAS Pain in Ambulatory Orthopedic Patients.

The purpose of this study was to investigate the correlation of Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI) score with traditionally collected visual analog scale (VAS) scores and to determine the influence of patient demographics on PROMIS PI and VAS scores. Patient demographics were collected, and PROMIS PI, PROMIS Physical Function (PF), and VAS questionnaires were distributed to 215 patients in orthopedic ambulatory clinics. The primary outcome was correlatio...

Impact of Food and Drug Administration Approval of Vismodegib on Prevalence of Orbital Exenteration as a Necessary Surgical Treatment for Locally Advanced Periocular Basal Cell Carcinoma.

To test the hypothesis that the US Food and Drug Administration approval of vismodegib in early 2012 has reduced the prevalence of orbital exenteration for locally advanced periocular basal cell carcinoma (BCC).

Perspective: Regulation of Pest and Disease Control Strategies and Why (Many) Economists are Concerned.

Pests and diseases are a continuous challenge in agriculture production. A wide range of control strategies have been and will continue to be developed. New control strategies are in almost all countries around the world assessed prior to approval for use in farmers' fields. This is rightly so to avoid and even reduce negative effects for human health and the environment. Over the past decades the approval processes have become increasingly politicized resulting in an increase in the direct approval costs a...

Assessment of return to play in professional overhead athletes subjected to arthroscopic repair of rotator cuff tears and associated labral injuries using the Italian version of the Kerlan-Jobe Orthopedic Clinic Shoulder and Elbow score.

The self-administered Kerlan-Jobe Orthopedic Clinic (KJOC) Shoulder and Elbow questionnaire is a reliable and sensitive outcome tool to assess upper extremity athletic performance and functional changes affecting return to play in overhead athletes. We report the results of a study of return to sport in professional overhead athletes at a mean follow-up of 2 years after arthroscopic repair of rotator cuff tears and associated labral injuries using the Italian version of the score.

Pyrotinib: First Global Approval.

Pyrotinib is an irreversible dual pan-ErbB receptor tyrosine kinase inhibitor developed for the treatment of HER2-positive advanced solid tumours. Based on positive results in a phase II trial, the drug recently received conditional approval in China for use in combination with capecitabine for the treatment of HER2-positive, advanced or metastatic breast cancer in patients previously treated with anthracycline or taxane chemotherapy. This article summarizes the milestones in the development of pyrotinib l...

Information Transparency in the Drug Approval Process.

First Approval of a Drug Derived from Marijuana.

Streamlining nonclinical drug development using the FDA 505(b)(2) new drug application regulatory pathway.

In the USA, drugs are approved by the FDA by three main regulatory pathways: (i) 505(b)(1) new drug applications (NDAs); (ii) 505(b)(2) NDAs; and (iii) 505(j) abbreviated NDAs (ANDAs). The appropriate pathway depends on the active ingredient, already approved drug products, drug formulation, clinical indication, route of exposure, among other factors. The 505(b)(2) NDA pathway is a regulatory approval pathway that allows sponsors to use existing public data in lieu of conducting studies; thus, potentially o...

Chinese approval for Ascletis' HCV drug is first homegrown success.

Information Transparency in the Drug Approval Process-Reply.

Effect of problem and scripting-based learning combining wearable technology on orthopedic operating room nurses' learning outcomes.

Orthopedic operating room (OR) nurses entail specialized skills and training, which are not part of the regular curricula at most nursing college. Instead, many nursing students' exposure to orthopedic care in the orthopedic range is limited to occasional observational assignments. Additionally, teamwork is an important factor affecting the performance of the orthopedic OR nurses. This results in a knowledge gap in clinical nursing education. Problem and scripting based learning (PSBL) method is a crucial t...

Development and validation of a new elbow-specific scoring system for patients with elbow stiffness: the Shanghai Elbow Dysfunction Score.

Clinical scoring systems are increasingly important and popular for the evaluation of orthopedic patients. Elbow stiffness commonly causes functional impairment and upper-limb disability. The purpose of this study was to develop and validate a new elbow-specific assessment score to evaluate joint function in patients with elbow stiffness.

US Food and Drug Administration's Approval of Aripiprazole Tablets With Sensor: Our Perspective.

Evolving Landscape of US Food and Drug Administration Drug Approval in the Era of Precision Oncology: Finding the Right Balance Between Access and Safety.

Duration of Pediatric Clinical Trials Submitted to the US Food and Drug Administration.

The increasing prevalence of pediatric chronic disease has resulted in increased exposure to long-term drug therapy in children. The duration of recently completed drug trials that support approval for drug therapy in children with chronic diseases has not been systematically evaluated. Such information is a vital first step in forming safety pharmacovigilance strategies for drugs used for long-term therapy in children.

FDA Approval Summary: Pembrolizumab for Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD-L1.

On September 22, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval for pembrolizumab (Keytruda, Merck & Co., Inc., Whitehouse Station, NJ) for the treatment of patients with recurrent, locally advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after two or more systemic therapies, including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2/neu-targeted therapy, and whose tumors express p...

Ethical approval for multicenter cohort studies on drug exposure during pregnancy: a survey among members of the European Network of Teratology Information Services (ENTIS).

The European Network of Teratology Information Services (ENTIS) is in a privileged position to perform independent post-marketing surveillance of drugs in pregnancy. The aim of this survey was to describe the legal requirements and procedures involved in obtaining ethical approval for collaborative cohort studies. We sent a survey questionnaire to all 28 Teratology Information Services (TIS), of which 25 (89%) in 18 countries completed our questionnaire. For 15 TIS, specific research ethical approval was ma...

US Food and Drug Administration Approval of Whole Slide Imaging for Primary Diagnosis: A Key Milestone Is Reached and New Questions Are Raised.

April 12, 2017, marked a significant day in the evolution of digital pathology in the United States, when the US Food and Drug Administration announced its approval of the Philips IntelliSite Pathology Solution for primary diagnosis in surgical pathology. Although this event is expected to facilitate more widespread adoption of whole slide imaging for clinical applications in the United States, it also raises a number of questions as to the means by which pathologists might choose to incorporate this techno...

Conserved cysteines in Mason-Pfizer monkey virus capsid protein are essential for infectious mature particle formation.

Retrovirus assembly is driven mostly by Gag polyprotein oligomerization, which is mediated by inter and intra protein-protein interactions among its capsid (CA) domains. Mason-Pfizer monkey virus (M-PMV) CA contains three cysteines (C82, C193 and C213), where the latter two are highly conserved among most retroviruses. To determine the importance of these cysteines, we introduced mutations of these residues in both bacterial and proviral vectors and studied their impact on the M-PMV life cycle. These studie...


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