by Mike Mitsock
Blog
A hole in the FDA’s approval process for pediatric drugs
By Tom Ulrich
You’d think drugs meant to be taken by children for years would be studied in children for a long time to measure their long-term safety.
You’d think drugs for a condition affecting millions of children would be tested in many, many children to catch any rare side effects.
You’d think all this would happen before the Food and Drug Administration, an agency known for its strict criteria, approved them for marketing.
US FDA publishes insight into 510(k) Substantial Equivalence determination process
By Stewart Eisenhart, Emergo Group
Indian regulators clarify requirements for medical device registrations, clinical trials
By Stewart Eisenhart, Emergo Group
New orders from the Indian Ministry of Health & Family Welfare’s Central Drugs Standard Control Organization (CDSCO) clarify some requirements regarding the country’s sometimes opaque medical device registration and clinical trial regulations.
A curriculum for medical device progress
By: Francis Kalush, Ph.D.
Horace, the greatest Roman poet of antiquity, spoke of the need to “seek for truth in the groves of Academe” — and in the last four years, my colleagues in FDA’s Center for Devices and Radiological Health (CDRH) and I took his advice. In scores of meetings and two large workshops, we consulted with hundreds of academics about a novel idea: a university-level program to address an important public health need by stimulating the development of new medical devices.
OpenFDA provides ready access to recall data
By: Taha A. Kass-Hout, M.D., M.S.
Stopping blindness: The drug-eluting contact lens
By David Altman
Growing up, my grandmother’s eyes were always a problem. For years, she was losing her central vision to glaucoma, and numerous surgeries and treatments did not seem to help. Later in life, she could not see my face but could always tell who I was when I was close.
Getting the most of mesenchymal stem cell transplants
Joseph Caputo originally wrote this post for the Harvard Stem Cell Institute (HSCI). Vector editor Nancy Fliesler contributed.
The game of numbers
The dark underbelly of health care is becoming all too visible now.
Fresh faces in neatly pressed white coats are in the halls. Eager. Enthusiastic. Clearly very bright. All hoping for a moment, an experience, an encounter that makes all their hard work worth it. Surely they’ll have one, but not before the thousands of keyboard clicks, the mandatory lectures, rounds and lots of lengthy, lonely call nights.
Regrowing corneas: It’s all about finding the stem cells
Severe burns, chemical injury and certain diseases can cause blindness by clouding the eyes’ corneas and killing off a precious population of stem cells that help maintain them. In the past, doctors have tried to regrow corneal tissue by transplanting cells from limbal tissue–found at the border between the cornea and the white of the eye. But they didn’t know whether the tissue contained enough of the active ingredient: limbal stem cells.
Malaysian medical device regulators change requirements for DoCs, AI requests
By Stewart Eisenhart, Emergo Group
Medical device market regulators in Malaysia have amended their Declaration of Conformity (DoC) and Additional Information Request requirements for manufacturers registering their products in the country.