Who What Why, September 7, 2017. Diana Zuckerman, president of the National Center for Health Research, points out that drug companies rely on a three-phase clinical trial process to gain FDA approval for their products. If RTT siphoned off patients with life-threatening illnesses from clinical trials, particularly for trials of medications serving limited populations with rare diseases, drug companies might find it even harder to enroll enough patients to complete them. And health insurers will not pay for drugs that lack FDA approval.
Marketwatch, July 28, 2017. An FDA announcement Friday included a proposal to lower nicotine levels in cigarettes and sent cigarette maker shares plunging.
The New York Times, July 11, 2017. Medical device makers might be able to delay reporting dangerous malfunctions to the FDA under a proposed agreement.
Bloomberg BNA: July 10, 2017. More than one thousand medical devices, including menstrual cups, and dentures, will be exempt from an FDA clearance process.
Bottom Line Inc., July 3, 2017. We asked Diana Zuckerman, PhD, to explain why many new cancer drugs have so few benefits…and how to get the right treatment.
While the number of morcellator cancer reports is decreasing, reports of injuries linked to Bayer’s Essure Permanent Birth Control device are on the rise.