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.
By Saturday, states must either sign or reject a proposed $26 billion opioid settlement with the three largest U.S. drug distributors — McKesson, Cardinal Health and AmerisourceBergen — and drugmaker Johnson & Johnson (J&J). Read More
The move comes about a year after Merck asked 340B entities to join a Merck program to provide claims data so the company could prevent duplicative discounts. Read More
The Fast Track designation is reserved for investigational therapies for serious or life-threatening conditions that could address unmet medical needs. Read More
The FDA’s ability to monitor drug facility compliance in fiscal year 2020 was significantly impacted by COVID-19, with only 745 inspections completed for the year vs. 1,367 in fiscal 2019. Read More
Reports of a vulnerability in the Blackberry operating system used in some pharmaceutical manufacturing equipment as well as in certain medical devices and device manufacturing has prompted the FDA to issue a cybersecurity alert. Read More
The Sackler family may withdraw from a proposed settlement to pay more than $4.3 billion to resolve thousands of lawsuits alleging their company Purdue Pharma helped fuel the nationwide opioid epidemic unless the family is granted legal immunity from current and future complaints. Read More
The Biden administration yesterday rolled out a plan to offer booster shots to people who are fully vaccinated against SARS-CoV2 with mRNA vaccines starting on Sept. 20. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) plans to cut an estimated 20 percent of its workforce, around 300 employees — and aims to take a back-seat approach in approving generics and to rely on actions taken by EU and U.S. drug regulators. Read More
FDA investigators observed several deficiencies in a March 30 to April 7 inspection of San Diego-based contract development and manufacturing organization (CDMO) Irisys, including the quality unit’s failure to document the review and approval of each batch production record. Read More