Califf confirmed as new FDA Commissioner

The “New” Prostate Cancer InfoLink is extremely pleased to see that, earlier today, the U.S. Senate has confirmed Dr. Robert Califf as the new Commissioner of the U.S. Food and Drug Administration (FDA), as a successor to Dr. Margaret Hamburg. … READ MORE …

The FDA’s perspective on the approval of HIFU in the USA

For those able to access the February 2016 issue of the AUA News, it carries an interesting article outlining the U.S. Food and Drug Administration’s perspective on exactly why the agency decided to approve two forms of high-intensity focused ultrasound (HIFU) technology for the transrectal ablation of prostate tissue. … READ MORE …

Approval criteria for SonaCare Medical’s HIFU technology

The U.S. Food & Drug Administration has now posted, on its web site, the approval letter issued to SonaCare Medical with reference to the approval to market the company’s Sonablate® 450 technology. … READ MORE …

The U.S. FDA wants your input — by December 4 this year

Do you have views on how the U.S. Food and Drug Administration (FDA) should be seeking and obtaining the views of patients during the development process for drugs and medical devices, and on ways to consider patients’ perspectives during regulatory discussions about the evaluation and approval of such products? … READ MORE …

How NOT to get your technology approved rapidly by the FDA

In a second statement to the media since an advisory panel to the U.S. Food and Drug Administration (FDA) decided not to recommend approval of EDAP TMS’s outdated form of Ablatherm technology for the treatment of low-risk prostate cancer, the company’s CEO seems to exhibit serious misunderstandings about how to work with the FDA. … READ MORE …

FDA advisory committee rejects Ablatherm application

In an entirely unsurprising result yesterday, an advisory committee to the U.S. Food and Drug Administration (FDA) voted very clearly against the approval of EDAP TMS’s Ablatherm technology for treatment of low-risk, localized prostate cancer using high-intensity focused ultrasound (HIFU). … READ MORE …

The FDA’s “take” on pre-chemo approval of abiraterone in mCRPC

A new article in Clinical Cancer Research offers us insights into the US Food and Drug Administration’s thinking about the approval of abiraterone acetate for the treatment of chemotherapy-naive patients with metastatic, castration-resistant prostate cancer (mCRPC). … READ MORE …

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