Medical Device Deals Update, May 2016
Derived from Strategic Transactions, Informa’s premium source for tracking life sciences deal activity, the Medical Device Deals Update column is a survey of recent medtech M&A, alliance, and financing activity. This month’s column covers deals announced March-April 2016.
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Access to expedited regulatory pathways, marketing exclusivity and tax credits in exchange for enrolling and retaining diverse clinical trial populations could provide a ‘carrot’ to the ‘stick’ in US FDA guidance and legislative proposals; attorneys Sarah Thompson Schick and Winston Kirton also call for a re-examination of concerns about remuneration for trial participants.
CBER Director Peter Marks said more sophisticated manufacturing expected in the next decade could lead to questions about whether gene therapies should be regulated by his center or CDRH.
US FDA’s Theresa Mullin envisions having a national catalog of standard core clinical outcomes assessment measures that could apply to every disease area.