medtechdive5 天
FDA names new head of medical device evaluation and quality
Ross Segan was chosen to lead the office, which handles premarket authorizations and recalls, in the agency’s Center for Devices and Radiological Health.
STAT9 天
FDA’s new head of device safety held senior role at company troubled by safety warnings
“Olympus’ continued failure to meet FDA requirements demonstrates a troubling disregard for patient safety,” said Jeffrey ...
Yahoo Finance6 天
FDA names new head of medical device evaluation and quality
Recommended Reading FDA defends Shuren’s tenure after report raises ethics concerns The Food and Drug Administration named Ross Segan as director of the medical device center’s Office of ...
STAT6 天
Millions of Americans want to quit smoking. Critics say drugmakers and the FDA are failing them
There hasn’t been a new class of drugs approved to help smokers quit since Pfizer's Chantix reached the market nearly two ...
Pfizer starts voluntary withdraw of OXBRYTA, benefit does not outweigh risks
Pfizer withdraws OXBRYTA after post marketing studies showed that the risks of side effects were greater than the benefits.
FiercePharma5 天
Ahead of adcomm, FDA challenges broad use of PD-1 drugs in stomach cancer patients
Besides stomach cancer, the FDA also raised a similar concern for PD-1 drugs in first-line esophageal squamous cell carcinoma ...
FDA Approves Emergency Use of Novavax COVID-19 Variant Vaccine...The number of vaccine ...
The Ministry of Food and Drug Safety approved Novavax's vaccine for emergency use today (30th) in response to the "COVID-19 ...
FDA issues recall notices over 2 brands of pet food due to salmonella and listeria risk
Answers Pet Food and Darwin’s Natural Pet Products, were found to have produced pet food that was contaminated with the ...
FDA expands use of Kisqali to early stage breast cancer patients
Women with early stage breast cancer may now take Kisqali, a medication already approved for advanced disease.