HomeAbout UsContact Us1-800-477-6037
Medical Device Daily
Archive Search

User ID

Password

Forgot password

Remember my login



New User ?

Products & Services
Medical Device Daily
Medtech Resources
BioWorld Executive Compensation Report 2014
MDD State of the Industry Report 2013
BioWorld and Medical Device VC Directory 2012
MDD Perspectives
BioWorld Today
Biotech Resources
Perspectives Blog
PMA and 501(k) Approvals


Today's Issue of Medical Device Daily

Sunday, February 14, 2016

Today's Headlines

Embattled Sientra gets ready to go back to work after certification debacle

BOGOTA, Colombia — After facing an unprecedented crisis last year, breast implants company Sientra Inc. reported that it is ready to resume its commercial activities next month.

POTUS, cancer and shooting for the moon

It was interesting to hear the President become archly ambitious about the oncological equivalent of a moonshot during his most recent State of the Union address. The President said veep Joe Biden would take the lead on an effort to break down "silos of data," which Biden said recently would halve the time needed to make advances in cancer care, and those in the private sector might be wondering how much of this talk of silos has to do with NIH's draft clinical trial data disclosure rule.

Inside the Beltway: User fee negotiations include a look at draft guidance issue

The negotiations for the next user fee schedule are well underway, and the FDA and device makers are addressing what some in industry see as sore spots. The FDA's proposals include development of a "myDevice" portal to allow for a more streamlined and interactive premarket review process, but the FDA has also said it would address the persistent draft status of guidances, vowing to take measures to ensure that guidances "are finalized in a timely manner."


MDD Home   |   About MDD   |   Contact Us   |   Copyright Notices   |   Terms of Use   |   Privacy Statement   |   Free Alerts

Part of Thomson Reuters
thomsonreuters.com | lifesciences.thomsonreuters.com | BioWorld.com | medicaldevicedaily.com