FDA: Evidentiary standards for drug development and approval
نویسندگان
چکیده
منابع مشابه
FDA drug approval summaries: fulvestrant.
Patients with hormone-sensitive breast cancer who have responded to tamoxifen may receive additional benefit from a second endocrine agent following progression or relapse after tamoxifen therapy. Fulvestrant (Faslodex((R)), ICI 182780, AstraZeneca Pharmaceuticals; Wilmington, Delaware) is a selective antagonist of estrogen designed to have no estrogenic effects. Lack of aqueous solubility led ...
متن کاملFDA drug approval summaries: oxaliplatin.
The purpose of this report is to summarize information on oxaliplatin, a drug recently approved by the U.S. Food and Drug Administration. Information provided includes regulatory history, study design, efficacy and safety results, and pertinent literature references. A single, multicenter, randomized trial, enrolling 463 patients with metastatic colorectal carcinoma whose disease had recurred o...
متن کاملInformation Requirements of Health Systems as Drug Purchasers : Does the FDA Have a Role in Setting Evidentiary Standards ? Paul
The objective of this article is to consider the information needs of drug purchasers; whether the Food and Drug Administration (FDA) should have a role in regulating information on the characteristics and cost-outcomes impact of new pharmaceutical products to health care purchasers; and the requirements in the new FDA Modernization Act of 1997 for "competent and reliable scientific
متن کاملTrends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study
OBJECTIVE To evaluate the use of special expedited development and review pathways at the US Food and Drug Administration over the past two decades. DESIGN Cohort study. SETTING FDA approved novel therapeutics between 1987 and 2014. POPULATION Publicly available sources provided each drug's year of approval, their innovativeness (first in class versus not first in class), World Health Org...
متن کاملFDA Approval Summary: Ramucirumab for Gastric Cancer.
The FDA approved ramucirumab (CYRAMZA; Eli Lilly and Company) for previously treated patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma initially as monotherapy (April 21, 2014) and subsequently as combination therapy with paclitaxel (November 5, 2014). In the monotherapy trial, 355 patients in the indicated population were randomly allocated (2:1) to recei...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Neurotherapeutics
سال: 2004
ISSN: 1933-7213,1878-7479
DOI: 10.1007/bf03206615