The Food and Drug Administration (FDA) is proposing to amend its regulations on acceptance of data from clinical studies for medical devices, to require that clinical studies conducted outside the United States as support for an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a premarket approval (PMA) application, a product development protocol (PDP) application, or a humanitarian device exemption (HDE) application be conducted in accordance with good clinical practice (GCP), which includes obtaining and documenting the review and approval of the study by an independent ethics committee (IEC) and obtaining and documenting freely given informed consent of study subjects.
IATI-BIOMED June 10-12 to be Crowd-Driven. The Israel Advanced Technology Industry (IATI) is taking the innovation conversation to the next level at its 12th annual IATI-BioMed Conference, and is inviting participants to take the stage and present their latest, most cutting edge developments in Life Sciences to date. For the first time ever, Israeli and international Biomed companies, scientists and entrepreneurs will be given the Chance-To-Speak and present their latest innovations at the IATI BioMed Conference, simply by submitting a 200 word abstract on the topic they wish to showcase.
Hot market sector: is biomed index will continue to rise? Biomed Index currently includes 24 stocks, with 25% of which are dual-listed stocks. There is solid ground and convenient for continued growth of the Israeli biomed companies, a process that is very similar to what has happened on the hi - tech industry 20 years ago.