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.
A bipartisan group of members of the House Energy and Commerce Committee introduced new legislation to reform the FDA’s monograph system for over-the-counter ingredients and replace the agency’s rulemaking process for approving OTCs with a system based on administrative orders. Read More
The FDA issued two guidances on postmarketing safety reporting for combination products, pushing back reporting requirements for certain combination products and clarifying reporting rules for their constituent parts. Read More
The agency includes complete summaries of study results, protocols and protocol amendments and statistical plans for all pivotal studies supporting the approval. Read More
The FDA issued the first clinical trial summary in its pilot program aimed at highlighting key information from pivotal trials of newly-approved drugs. Read More
Five Manhattan doctors accepted kickbacks and bribes from Insys to prescribe its fentanyl products, according to the U.S. Attorney for the Southern District of New York. Read More
The Massachusetts Supreme Judicial Court ruled that Merck may be held liable for injuries caused by inadequate labeling for generics of its products. Read More
President Trump said that his administration will cut nationwide opioid prescriptions by one third over the next three years and increase funding for non-addictive painkiller development. Read More
He also spoke about the Prescription Interdiction and Litigation Task Force, which focuses on targeting opioid manufacturers and distributors that have contributed to the epidemic. Read More