FDA should be split up – and stop covering food, says White House

November 29, 2018 The current dual role makes no sense, according to a White House document that wants around 5,000 FDA staffers transferred to the U.S. Department of Agriculture so that all food regulation occurs under one roof.  The current structure at the FDA is a relic of the early 1900s that “introduces greater risk, … Read more

Gates Foundation’s $100M-a-year nonprofit biotech takes flight

November 27, 2018 Details of Gates MRI first emerged more than 12 months ago; however, at that point the project was yet to move past the operational design phase.  Now, the R&D operation has temporary digs in Cambridge, Massachusetts, and a leadership team lured from companies including Baxalta, Merck and Shire by the promise of … Read more

Gates Foundation and U.K. pledge $50M to superbug treatment drive

November 25, 2018 The CARB-X project — which announced the new funding at the World Health Assembly meeting in Geneva in May — was set up two (2) years ago as a public-private partnership to provide funding for new projects that address the global rise of antibiotic-resistant bacteria, particularly in low- and middle-income countries. It’s … Read more

FDA passes on setting new regulations for medical device servicing

November 20, 2018 Instead, the Agency found that many OEMs and third parties provided high-quality, safe and effective servicing, such as refurbishing and reselling more durable equipment including imaging machines, automated external defibrillators, endoscopes and ventilators.  “We believe the currently available objective evidence is not sufficient to conclude whether or not there is a widespread … Read more

Price check at FDA: Trump pushes for pharma ads with dollar signs

November 15, 2018 In May, Department of Health and Human Services (DHHS) Secretary Alex Azar called on pharma companies to voluntarily add drug prices to ads.  “Be honest about what you’re trying to charge us, and put your list prices in your ads,” Azar said during a speech outlining details about the bigger plan, the … Read more

Cheap-date doctors prescribed more opioids after pharma picked up dinner tab

November 13, 2018 Each additional meal purchased was associated with an increase of 0.7% in opioid claims by doctors, according to the research published in JAMA.  Meals were the perk most frequently accepted by doctors — more than 97,000 physicians let pharma pick up the tab for breakfasts, lunches or dinners for a total of $1.81 … Read more

FDA floats end to ‘confusing and inefficient’ drug-device process

November 08, 2018 Developers of therapies that feature device and drug or biologic components can ask the FDA to classify their products.  These classifications are based on the primary mechanism of action and determine how the regulator handles combination products.  That process looks set to survive the first major review of the regulations since 1991. … Read more

FDA Moves to Improve Device Safety Through Safer Designs

November 05, 2018 The Agency intends to focus more of its policies on supporting developers that pursue safer devices, he said. As part of its new Medical Device Safety Action Plan the agency raised the possibility of providing an approval path for safer devices that don’t meet its Breakthrough Program criteria but are intended to … Read more