By KATIE THOMAS GlaxoSmithKline plans to open up much of its drug research in an apparent effort todeflect criticism that important information gathered in clinical trials often does not see the light of day. The move, a first for a major pharmaceutical company, is scheduled to be announced on Thursday by its chief executive,…
By RACHEL SASLOW Mammograms have entered a new dimension, literally. At some screening centers, women are now being offered a 3-D technology that costs more and involves more radiation but may provide a better look. The Food and Drug Administration approved the 3-D mammography device in 2011, and the technique is becoming more common in…
By RACHEL SASLOW Mammograms have entered a new dimension, literally. At some screening centers, women are now being offered a 3-D technology that costs more and involves more radiation but may provide a better look. The Food and Drug Administration approved the 3-D mammography device in 2011, and the technique is becoming more common in…
By STEPHANIE BEASLEY A former FDA orphan drug official and industry consultant called the recently created breakthrough designation the most “immediately useful” of several provisions in the FDA Safety And Innovation Act that could benefit rare diseases, making the remarks following a product consultation meeting with FDA about using the new pathway. FDA’s top drug…
By THOMAS BURTON A White House advisory body on Tuesday unveiled a plan to double the number of new prescription drugs that go on the market each year by more quickly approving drugs to treat high-risk patients. The President’s Council of Advisors on Science and Technology urged the Food and Drug Administration to expand its…
By THOMAS BURTON A White House advisory body on Tuesday unveiled a plan to double the number of new prescription drugs that go on the market each year by more quickly approving drugs to treat high-risk patients. The President’s Council of Advisors on Science and Technology urged the Food and Drug Administration to expand its…
Diagnostic test quality may not be something that pharmaceutical and biotechnology companies have had a lot of experience dealing with, but shortfalls in a diagnostic development program can undercut efforts to streamline clinical trials for personalized medicines. The need for a high-quality diagnostic test development program was a key message delivered by a representative from…
By GINA KOLATA In findings that are fundamentally reshaping the scientific understanding of breast cancer, researchers have identified four genetically distinct types of the cancer. And within those types, they found hallmark genetic changes that are driving many cancers. These discoveries, published online on Sunday in the journal Nature, are expected to lead to new…
By MARGARET HAMBURG, M.D. One of the privileges of being the head of the Food and Drug Administration is being able to report on the accomplishments of the dedicated and highly skilled employees who are advancing the public health mission of our agency. Last night, I had the pleasure of participating in an event honoring…
By MARGARET HAMBURG, M.D. One of the privileges of being the head of the Food and Drug Administration is being able to report on the accomplishments of the dedicated and highly skilled employees who are advancing the public health mission of our agency. Last night, I had the pleasure of participating in an event honoring…
