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 FDA outlined its latest thinking on patient-focused drug development in a final guidance released on Friday, including ways to gather information that can be used for trial design. Read More
Johnson & Johnson (J&J) and three drug wholesalers have reached a deal to pay out $26 billion to settle thousands of lawsuits over their business practices, which plaintiffs claim fueled the deadly opioid crisis over the past two decades. Read More
The FDA “has concerns about the integrity of the data generated from the nonclinical toxicity studies conducted at your testing facility,” said the warning letter. Read More
The CDC stressed that a shorter period between a first and second shot is recommended for those who are immune-compromised, adults who are 65 years old and up and those who are at greater risk of severe disease or who require immediate protection because of where they work. Read More
Boise, Idaho-based Smart Surgical, which does business as Burst Biologics, failed to ensure that its blood products were free of the threat of infection and contamination, the FDA said in a warning letter to the company. Read More
The move follows a December injunction temporarily halting pay-for-delay agreements between branded drug manufacturers and makers of generics in the state. Read More
The FDA’s Office of Pharmaceutical Quality (OPQ) used alternative tools because of the ongoing pandemic that reduced the number of facilities needing pre-approval inspections by more than 50 percent in fiscal 2021, OPQ said in its annual report released yesterday. Read More
The European Medicines Agency (EMA) recommended 92 medicines for authorization by the European Commission in 2021, 53 of which had a new active substance that had not been authorized in the EU before. Read More