By: Scott Gottlieb, M.D. Too many patients are being priced out of the medicines they need. While FDA doesn’t have a direct role in drug pricing, we can take steps to help address this problem by facilitating increased competition in the market for prescription drugs through the approval of lower-cost, generic medicines. Over the last […]
Food & Drug Administration (FDA)
Fostering medical innovation: A plan for digital health devices
By: Scott Gottlieb, M.D. It is incumbent upon FDA to ensure that we have the right policies in place to promote and encourage safe and effective innovation that can benefit consumers, and adopt regulatory approaches to enable the efficient development of these technologies. By taking an efficient, risk-based approach to our regulation, FDA can promote […]
Controlled-release ADHD drug wins FDA approval
Neos Therapeutics (NSDQ:NEOS) won FDA approval yesterday for its controlled-release formulation of an old ADHD drug, methylphenidate. The company touts its product, Cotempla XR-ODT, as the 1st methylphenidate tablet designed to release medication over time instead of all at once. For years, children with ADHD have been treated with methylphenidate and amphetamines. But kids can sometimes […]
Senate drug price hearing turns into debate over healthcare reform
Members of the Senate Health, Education, Labor and Pensions committee gathered last week to discuss the rising costs of prescription drugs. But the hearing quickly morphed into a heated back-and-forth between senators over the Republican’s efforts to reform healthcare. Democratic senators, including Sens. Patty Murray (D-Wash.) and Chris Murphy (D-Conn.), used their time to criticize […]
FDA clears IND for Cerveau’s tau imaging agent
Cerveau Technologies said today that the FDA cleared the investigational new drug application for its tau imaging agent. The company plans to work with pharmaceutical partners to evaluate the product’s use in positron emission tomography scans to assess neurofibrillary tangles in the brain. NFTs composed of aggregated tau protein are characteristic of certain neurodegenerative conditions like […]
Novartiz unit Sandoz seeks FDA nod for generic Advair Diskus
Novartis (NYSE:NVS) unit Sandoz said today that the FDA has accepted the abbreviated new drug application for its generic version of Advair Diskus. The fluticasone propionate/salmeterol device is designed to treat asthma in patients ages 4 and older, as well as provide maintenance treatment of airflow obstruction and reduce exacerbations in patients with chronic obstructive […]
How creative FDA regulation led to first-in-the-world approval of a cutting-edge heart valve
By: Jeffrey Shuren, M.D., J.D., and Bram Zuckerman, M.D. Nearly six years ago FDA approved an artificial transcatheter heart valve (THV) to treat patients having severe symptoms and life-threatening heart problems such as fainting, chest pain, heart failure, irregular heart rhythms, or cardiac arrest, because one of the valves in their heart (the aortic valve) […]
Lilly wins FDA nod for Humalog pre-filled Junior KwikPen device
Eli Lilly (NYSE:LLY) said today that the FDA approved its Humalog Junior KwikPen for the treatment of diabetes. The device is a pre-filled pen with half-unit dosing capabilities, which Eli Lilly said gives patients access to finer dose adjustment. “We are pleased to be able to meet the needs of people who prefer a prefilled […]
Statement from FDA Commissioner on opioid drugs with abuse-deterrent properties
Last month, I asked my colleagues at the FDA to identify what additional and more forceful steps the FDA can take, on top of the vigorous work the agency is already doing, to address the crisis of opioid addiction. Everyone at the FDA is committed to focusing on all aspects of the epidemic. The new […]
Cleveland Clinic spinout Infuseon wins FDA nod for CNS drug delivery device
Cleveland Clinic spinout Infuseon Therapeutics said today that its novel central nervous system delivery device won 510(k) clearance from the FDA as a therapeutic delivery device. The company’s Cleveland Multiport Catheter, which won FDA clearance in March, was designed to effectively deliver therapeutics to the brain. Usually, the blood brain barrier prevents drugs delivered in […]