Detecting the small signals of climate change for the most essential climate variables requires that satellite sensors make highly accurate and consistent measurements. Data gaps in the time series (such as gaps resulting from launch delay or failure) and inconsistencies in radiometric scales between satellites undermine the credibility of fundamental climate data records, and can lead to erron...

Fear of lawsuits and customer confusion have greeted a Food and Drug Administration plan to let generic drug companies change labels quickly, without prior agency approval, when they learn of adverse effects once the generic reaches the market.

PURPOSE Pharmacy compounding of prescription therapies that do not have Food and Drug Administration (FDA) approval increases administrative costs to managed care organizations and may also place members at risk for poor outcomes. This paper provides health care administrators with information and tools that can be used to manage risk-encouraged practices from pharmacy compounders, and suggests...

We explore the determinants of inspection outcomes across 1.6 million Occupational Safety and Health Agency (OSHA) audits from 1990 through 2010. We find that discretion in enforcement differs in state and federally conducted inspections. State agencies are more sensitive to local economic conditions, finding fewer standard violations and fewer serious violations as unemployment increases. Larg...

New procedures and materials for incontinence and prolapse are proliferating rapidly. Surgical procedures were developed by physicians and carried their names, but over the last 15 years, these procedures are developed by industry and bear the trade names of the companies selling the kits needed to perform them. The Food and Drug Administration (FDA) approves devices, not procedures, and does n...

Scientists and academics are used to defending their theories, methods, and results in the classroom, at conferences, and in peer-reviewed publications. But Pieter Cohen, an assistant professor at Harvard Medical School, learned that he had to defend his research in a defamation suit while reading a supplement industry trade publication (Robins, 2017). Cohen is known as a “dogged detective” for...

BACKGROUND Phase III clinical trials and Food and Drug Administration (FDA) regulatory decisions are critical for success of new drugs and can influence a company's market valuation. Knowledge of trial results before they are made public (ie, "inside information") can affect the price of a drug company's stock. We examined the stock prices of companies before and after public announcements rega...

Editor’s note: The author was employed as a pharmacy consultant by the Healthcare Financing Administration (now the Centers for Medicare and Medicaid) until his retirement in 1999. He was one of the few officials who consulted with professional organizations outside government in the process of developing those regulations. The Omnibus Budget Reconciliation Act of 1987 (OBRA ’87) resulted in re...

The U.S. pharmaceutical industry plays a vital role in shaping the face of American healthcare. As an industry rooted in innovation, its continued evolution is inherent. With major patent expirations looming and thin product pipelines, the industry now must consider new directions to maintain growth and stability. Follow-on biologics, derived from living organisms and marketed after the patent ...

The American Association for Health Freedom (AAHF) and the Alliance for Natural Health (ANH) would like to thank the Food and Drug Administration (FDA) for giving us the opportunity to make this submission. Both organizations, which are formally affiliated, represent a wide range of natural health interests including consumers, food business operators and practitioners in the United States, Eur...