We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The federal government’s guidance for monitoring opioid use among Medicare beneficiaries does not go far enough in identifying which beneficiaries are most at risk and the Centers for Medicare & Medicaid Services should collect data on exactly how many at-risk beneficiaries receive high doses, according to a new GAO report. Read More
The federal government pushed back its revisions to the Common Rule for an additional six months — making the announcement less than 36 hours before the changes were set to take effect Jan. 19 — and warned the public to expect additional delays down the line. Read More
In 2018, the European Medicines Agency’s quality and safety working groups intend to tackle several new guidelines, covering the sterilization of products and containers, risk-based prevention of cross contamination in manufacturing and requirements for products containing a device delivery component. Read More
Quality experts and FDA officials predict 2018 will bring more streamlined FDA inspections and a greater focus on digital records and data integrity, as the agency implements its ambitious Concept of Operations initiative. Read More
The GAO called on the FDA to make its plans for publishing and revising guidance for nonbiological complex drugs (NBCDs) public, noting that sudden guidance changes cause a major expense for generics developers and can delay or prevent market entry of products. Read More
The FDA will delay implementing “intended use” sections of a final rule while reassessing language that industry groups said could cause confusion. Read More
The FDA will begin publishing information from sponsor-produced clinical study reports, starting with documents volunteered by companies following a drug’s approval, as part of a broader agency effort to boost transparency in clinical trials. Read More