Search results
Results from the WOW.Com Content Network
Prescription drug list prices in the United States continually are among the highest in the world. [1] [2] The high cost of prescription drugs became a major topic of discussion in the 21st century, leading up to the American health care reform debate of 2009, and received renewed attention in 2015.
Part of the problem was the CAFC's decision in Roche Products, Inc. v. Bolar Pharmaceutical Co., which interpreted existing U.S. law as prohibiting generic competitors from performing tests required for FDA approval using patented methods, until the patents expired. [2] In response, the Hatch-Waxman Act was negotiated and enacted. [3]
Within quality management systems (QMS) and information technology (IT) systems, change control is a process—either formal or informal [1] —used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. It reduces the possibility that unnecessary changes will be introduced to a system without ...
(Reuters) -Pharmaceutical companies are due to receive by Thursday the U.S. government's opening proposal for what are expected to be significant discounts on 10 of its high-cost medicines, an ...
Drug companies raised prices on 910 name-brand drugs in January. The median price increase was 4.7%, the lowest increase in over a decade.
The Biden administration said on Tuesday it has responded to offers from the manufacturers of 10 high-cost drugs selected for the U.S. Medicare program's first-ever pricing negotiations, but ...
The Pharmaceutical Inspection Co-operation Scheme is an informal agreement between health authorities instead of a formal treaty between countries. PIC and the PIC Scheme, which operate together in parallel, are jointly referred to as PIC/S. PIC/S became operational in November 1995.
Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA).