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More than 70 million people around the world have been infected with HIV and some 35 million have died since the AIDS epidemic began, according to WHO statistics. Read More
Gilead said it is in “ongoing discussions with NICE to identify appropriate treatment comparators which can clarify how cell therapy may be made available to patients in the UK.” Read More
The firm had not defined, documented or implemented design control procedures that addressed design input, outputs, review, verification, validation or design changes, according to the nine-item 483. Read More
The FDA said it would explore whether it has the authority to issue “umbrella regulations” to identify devices that may require additional training or user education beyond the physician labeling currently required. Read More