Search Results for JAMA

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FDA Continues Steady Reduction of Generic Drug Application Backlog By Zachary Brennan - Published 25 July 2016

As the debate around high-priced pharmaceuticals and new ways to lower those costs continues, the US Food and Drug Administration (FDA) is speeding the approval of new generic drugs, according to the latest update to the agency’s in-depth look at the backlog of abbreviated new drug applications (ANDAs).

Categories: News, US, FDA, Crisis management, Generic drugs, Due Diligence, Government affairs, Manufacturing

Tags: ANDA backlog, generic drug approval, Woodcock, JAMA

Five Years of Cancer Drug Approvals: Most Cost Too Much and Give Us Too Little By Vinay Prasad MD, MPH - Published 17 December 2015

This is the guest post rebuttal (to this post from Mark Shapiro, VP of Clinipace) by Dr. Vinay Prasad, Assistant Professor of Medicine in the Division of Hematology Oncology in the Knight Cancer Institute. Prasad also holds appointments in the Department of Public Health and Preventive Medicine, and as Senior Scholar in the Center for Health Care Ethics at Oregon Health & Science University.

Categories: News, US, FDA, Clinical, Crisis management, Drugs, Government affairs

Tags: cancer drugs, oncology drug pricing, JAMA, cancer drug approvals

Five Years of Cancer Drug Approvals: Pricing, Novelty and Improvement By Mark Shapiro, MA, MBA - Published 17 December 2015

Mark Shapiro, vice president of clinical development at contract research organization Clinipace, considers a recent JAMA study on cancer drug pricing in a guest post for Focus. A rebuttal to this post by one of the authors of the JAMA article, Dr. Vinay Prasad, can be found here.

Categories: News, US, FDA, Drugs, Ethics, Government affairs, Manufacturing, Quality

Tags: cancer drug pricing, Clinipace, JAMA, novelty cancer drugs, oncology

Researchers Question FDA's Use of Surrogate Endpoints for Cancer Drug Approvals By Michael Mezher - Published 19 October 2015

Two researchers are questioning the US Food and Drug Administration's (FDA) use of surrogate endpoints in approving new oncology drugs and the agency's failure to more strictly enforce postmarketing study requirements for these drugs, according to a letter appearing in JAMA Internal Medicine.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Postmarket surveillance, Submission and registration

Tags: Surrogate endpoints, end points, Vinay Prasad, Chul Kim, JAMA Internal Medicine

Is a Drug Unsafe or Just Unprofitable? How a Lack of Data Clouds Regulatory Classifications By Alexander Gaffney, RAC - Published 14 November 2014

Regulatory professionals are frequently concerned with getting pharmaceutical products approved for use and available to consumers. But as a new paper in the Journal of the American Medical Association (JAMA) explains, the way in which drug products are withdrawn from the market can have significant implications for both regulators and patients as well.

Categories: News, US, CDER, Drugs, Postmarket surveillance

Tags: Withdrawal, Bexxar, JAMA, Paper, Postmarketing Study

Study: OTC Drug Advertising Lacks Sufficient Balance of Risks, Benefits By Alexander Gaffney - Published 12 September 2012

Categories: FDA, FTC

Tags: JAMA, OTC, Latest News, pharmaceutical, marketing, advertising, study, fair balance, drug

Study: Most Drugs Lacking Information on Adequate Pediatric Use By Alexander Gaffney - Published 09 May 2012

Tags: PDR, ePDR, JAMA, Kids, Children, Pediatric, Report, Latest News, pharmaceutical, testing, study, drug

Study: Many Clinical Trials Small, of Poor Quality By Alexander Gaffney - Published 02 May 2012

Categories: Quality

Tags: ClinicalTrials.gov, JAMA, Size, analysis, Latest News, study, clinical trials