Diabetes: FDA warns Dexcom on adverse event reports
March 25, 2014 by Brad Perriello
Dexcom Inc. said the FDA flagged its adverse event reporting system for not being compliant with new medical device reporting rules.
The federal watchdog agency issued a warning letter to San Diego-based Dexcom, which makes continuous glucose monitors for diabetics, after an inspection in November 2013, according to a press release. Read more
Guided Therapeutics wants a sit-down with FDA
March 27, 2014 by Brad Perriello
Guided Therapeutics said it’s asked the FDA for a face-to-face meeting as it tries to resurrect the pre-market approval application for its LuViva cervical scanning device.
Norcross, Ga.-based Guided Therapeutics said it wants the sit-down to happen in the next 60 to 90 days so it can discuss the issues raised in a non-approvable letter the FDA issued last year. The federal watchdog agency granted a 180-day extension on the PMA filing, the company said. Read more
Women scientists at FDA: A legacy to be proud of
March 28, 2014 by MassDevice
This is National Women’s History Month, a good time to reflect on FDA’s history of advancing women as scientists and health professionals. This tradition began with FDA’s predecessor in the late 19th and early 20th centuries, the Bureau of Chemistry in the Department of Agriculture. Several early female FDA scientists came out of the University of Pennsylvania, one of the first universities in the country to offer women chemistry degrees in the late 19th century.
Harvey Wiley, known as the Father of the 1906 Pure Food and Drugs Act and its “crusading chemist,” hired FDA’s first female laboratory chief. When his superiors found out that the “M. E. Pennington” he had selected to head a research laboratory was actually Mary Engles Pennington, he successfully argued that since she had received the top score on the Civil Service exam, he had no grounds on which to refuse her the position. His argument carried the day. Read more
Japanese regulators plan faster medical device registration process
March 31, 2014 by MassDevice
By Stewart Eisenhart, Emergo Group
A recent presentation by the Japanese Ministry of Health, Labour and Welfare’s Medical Device Evaluation office has shed more light on planned changes to the country’s medical device market regulatory system.
According to Emergo Group’s Tokyo office, the changes include both high-level amendments to Japan’s Pharmaceutical Affairs Law (PAL) applicable to both medical devices and drugs, and also measures specifically geared toward medical devices. Read more
FDA wants your perspective on clinical trial demographic data
March 31, 2014 by MassDevice
When designing clinical trials, it is essential to test the safety and effectiveness of medical products in the people they are meant to treat. Although FDA’s policies, guidances, and regulations reflect decades of agency efforts to foster the participation of diverse patient populations in clinical trials, more work is required.
FDA is seeking your comments on this important public health issue. On Tuesday, April 1, 2014, we’re holding a public hearing on the challenges of collecting and analyzing information on demographic subgroups—including sex, race, ethnicity and age—in clinical trials for FDA-regulated medical products. Read more
