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Total 7385 results found since Jan 2013.

Next Phase of NIH Preprint Pilot Launching Soon
Last month, the National Library of Medicine (NLM)announced plans to extend its NIH Preprint Pilot in PubMed Central (PMC) and PubMed beyond COVID-19 to encompass all preprints reporting on NIH-funded research. The second phase of the pilot, launching later this month, will include preprints supported by an NIH award, contract, or intramural program and posted to aneligible preprint server on or after January 1, 2023.In preparation for the launch of this second phase, we have updated PMC and PubMed site features to help users of these databases incorporate the increased volume of preprints into their discovery workflows. S...
Source: PubMed Central News - January 10, 2023 Category: Databases & Libraries Source Type: news

Second Phase of the NIH Preprint Pilot Launched
Today, we are pleased to announce the launch of the second phase of the NIH Preprint Pilot with the addition of more than 700 new preprint records to PubMed Central (PMC) and PubMed. This second phase expands the scope of the Pilot to include preprints resulting from all NIH-funded research. Eligible preprints are those acknowledging direct support of an NIH award or authored by NIH staff and posted to bioRxiv, medRxiv, arXiv, or Research Square, on or after January 1, 2023. NLM will automatically include the full text of the preprint (as license terms allow) and associated citation information in PMC and PubMed, respectiv...
Source: PubMed Central News - January 30, 2023 Category: Databases & Libraries Source Type: news

FDA Building a Prescription Drug and Marketing Database
Over the last several years, we have written extensively about the potential implications that the Physician Payments Sunshine Act will have on physicians and the life sciences industry. One of the greatest implications is that numerous government and private entities will be able to use the publicly posted payment data to "data mine" for certain trends and information to identify potentially fraudulent behavior or medically unnecessary services. Living up to our predictions, although somewhat indirectly related to the Sunshine Act, the Food and Drug Administration's (FDA) Office of Criminal Investigations (OCI) recentl...
Source: Policy and Medicine - June 12, 2013 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs

FDA’s CDER and CDRH Release 2015 Guidance Agenda and Comprehensive Document Search Tool
The Food and Drug Administration seems poised for a busy 2015. The Agency’s Center for Drug Evaluation and Research (CDER) just released their annual guidance document agenda for 2015. They intend to publish 90 guidance documents this year, including several aimed at advertising, biosimilars, pharmaceutical quality and manufacturing standards, and the Drug Supply Chain Security Act. The Center for Devices and Radiological Health (CDRH) released their 2015 plan as well--indicating Laboratory Developed Test and software-related guidances are in the works. To cap off a busy new year, FDA also released a well-organized guida...
Source: Policy and Medicine - January 14, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs

Be Careful What You “Like”: Healthcare Industry Should Consider Privacy, Adverse Events, and Promotional Issues in Social Media Interactions
Social media offers the healthcare industry an opportunity to engage with patients, care givers, and physicians on health care topics in real-time. While Jennifer Chillas, Senior Counsel at Bristol-Myers Squibb, believes social media is an attractive frontier, she offered many thought-provoking considerations regarding company comment sections and real-time interactions via Facebook and Twitter at the recent Pharmaceutical Compliance Congress. In her presentation "Compliant Social Interactions and Engagements," Chillas spoke specifically about patient privacy, adverse event reporting, and promotional issues related to user...
Source: Policy and Medicine - February 26, 2014 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs

Use of internet search logs to evaluate potential drug adverse events.
Abstract Internet search logs provide an abundant source of data that can be explored for purposes such as identifying drug exposure-adverse event relationships. The methodology to rigorously conduct such evaluations is not well characterized, and the utility of such analyses is not well defined. In this issue, White and colleagues propose an approach using Internet search logs for this purpose and compare it to parallel analyses conducted using the US Food and Drug Administration's spontaneous reporting database. PMID: 25056395 [PubMed - in process]
Source: Clinical Pharmacology and Therapeutics - July 28, 2014 Category: Drugs & Pharmacology Authors: Sarntivijai S, Abernethy DR Tags: Clin Pharmacol Ther Source Type: research

Director's Comments: Internet Search Provides Early Warning of Drug Interaction
Listen to the NLM Director's Comments on "Internet Search Provides Early Warning of Drug Interaction". The transcript is also available. A novel Internet search (based on six million users) discovered harmful side effects from taking two prescription medicines — prior to safety warnings from the conventional, physician-based reporting method used by the U.S Food and Drug Administration (the FDA)...
Source: What's New on MedlinePlus - May 17, 2013 Category: Consumer Health News Source Type: news

Search for Inhibitors of the Ubiquitin-Proteasome System from Natural Sources for Cancer Therapy.
Abstract Since the approval of the proteasome inhibitor, Velcade(®), by the Food and Drug Administration (FDA) for the treatment of relapsed multiple myeloma, inhibitors of the ubiquitin-proteasome system have been attracting increasing attention as promising drug leads for cancer therapy. While the development of drugs for diseases related to this proteolytic system has mainly been achieved by searching libraries of synthetic small molecules or chemical modifications to drug leads, limited searches have been conducted on natural sources. We have been searching natural sources for inhibitors that target this prot...
Source: Chemical and Pharmaceutical Bulletin - February 3, 2016 Category: Drugs & Pharmacology Authors: Tsukamoto S Tags: Chem Pharm Bull (Tokyo) Source Type: research

FDA Regulates Internet Search
The Food and Drug Administration wants to regulate Internet search.
Source: Forbes.com Healthcare News - February 15, 2013 Category: Pharmaceuticals Authors: Scott Gottlieb Source Type: news

Clarification of P-glycoprotein inhibition-related drug-drug interaction risks based on a literature search of the clinical information.
Abstract Abstract 1.  Recently, the Food and Drug Administration (FDA) and European Medicines Agency have shown decision trees to determine whether a drug candidate is an inhibitor of P-glycoprotein (P-gp). However, there has been no clear information on whether P-gp inhibition can be significant in clinical drug-drug interactions (DDIs). The purpose of this study was to confirm the effect of P-gp inhibition through comprehensive analysis of the clinical DDI studies. 2.   Clinical information on P-gp inhibition was collected using the University of Washington Metabolism and Transport Drug Interaction Database...
Source: Xenobiotica - June 17, 2014 Category: Research Authors: Umeyama Y, Fujioka Y, Okuda T Tags: Xenobiotica Source Type: research

Title: In Search of “Just Right”: The Challenge of Regulating Arsenic in Rice
Charles W. Schmidt, MS, an award-winning science writer from Portland, ME, has written for Discover Magazine, Science, and Nature Medicine. Background image: © Koji Kitagawa/amanaimages/Corbis About This Article open Citation: Schmidt CW. 2015. In search of “just right”: the challenge of regulating arsenic in rice. Environ Health Perspect 123:A16–A19; http://dx.doi.org/10.1289/ehp.123-A16 News Topics: Agriculture and Farming, Arsenic, Diet and Nutrition, Drinking Water Quality, Food Safety and Regulation, Laws, Regulations, and Policy, Risk Assessment, Soil Pollution, Standards Published: 1 January 2015 PDF Ver...
Source: EHP Research - December 31, 2014 Category: Environmental Health Authors: Web Admin Tags: Featured News Spheres of Influence Agriculture and Farming Arsenic Diet and Nutrition Drinking Water Quality Food Safety and Regulation Risk Assessment Soil Pollution Standards Source Type: research

Map of drugs reveals uncharted waters in search for new treatments
(Institute of Cancer Research) Scientists have created a map of all 1,578 licensed drugs and their mechanisms of action -- as a means of identifying 'uncharted waters' in the search for future treatments. Their analysis of drugs licensed through the Food and Drug Administration reveals that 667 separate proteins in the human body have had drugs developed against them -- just an estimated 3.5 percent of the 20,000 human proteins.
Source: EurekAlert! - Medicine and Health - December 2, 2016 Category: Global & Universal Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA ’s Adverse Event Reporting System (FAERS) and new search tool
Source: Food and Drug Administration - October 2, 2017 Category: American Health Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA ’ s Adverse Event Reporting System (FAERS) and new search tool
Source: Food and Drug Administration - October 2, 2017 Category: American Health Source Type: news

The Search for an Alternative to 68GaGa-DOTA-TATE in Neuroendocrine Tumor Theranostics: Current State of 18F-labeled Somatostatin Analog Development
The trend to inform personalized molecular radiotherapy with molecular imaging diagnostics, a concept referred to as theranostics, has transformed the field of nuclear medicine in recent years. The development of theranostic pairs comprising somatostatin receptor (SSTR)-targeting nuclear imaging probes and therapeutic agents for the treatment of patients with neuroendocrine tumors (NETs) has been a driving force behind this development. With the Neuroendocrine Tumor Therapy (NETTER-1) phase 3 trial reporting encouraging results in the treatment of well-differentiated, metastatic midgut NETs, peptide radioligand therapy (RL...
Source: Theranostics - June 13, 2019 Category: Molecular Biology Authors: Christopher M. Waldmann, Andreea D. Stuparu, R. Michael van Dam, Roger Slavik Tags: Review Source Type: research