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since an advisory panel to the U.S. Food and Drug Administration (FDA) decided not to recommend approval of EDAP TMS’s outdated form of Ablatherm technology for the treatment of low-risk prostate cancer, the company’s CEO seems to exhibit serious misunderstandings about how to work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

FDA shutters nearly 1,700 illegal on-line pharmacies

Working in association with the U.S. Department of Justice and INTERPOL, the U.S. Food and Drug Administration (FDA) has just managed to shut down nearly 1,700 illegal pharmacy web sites and confiscate some $40 million worth of illegal medicines. So … READ MORE …

FDA checking on reports of “problems” with da Vinci robot

According to an on-line report in the Financial Times published late last night, “The FDA has received an increase in reports of problems associated with [Intuitive’s  da Vinci robotic surgical technology] and said it is trying to weigh the risks and benefits of using robotic surgery rather than conventional surgery.” … READ MORE …

US FDA grants priority review for radium-223

The U.S. Food and Drug Administration (FDA) has granted a priority review for radium-223 dichloride in the treatment of men with castration-resistant prostate cancer (CRPC) and bone metastases. … READ MORE …

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