Posted on October 24, 2011 Updated on June 21, 2012
This entry was posted in Positioning- Upper limb.
Very neat blog.Thanks Again. Fantastic.
group investing club
[…]always a significant fan of linking to bloggers that I really like but do not get lots of link really like from[…]
Major thanks for the post.Thanks Again. Really Cool.
free online advertising
Thank you ever so for you post.Really thank you! Much obliged.
Thanks a lot for the blog post.Much thanks again. Want more.
download free The Expendables 3 hollywood
I think this is a real great blog post.Really thank you! Want more.
I think this is a real great blog article.Thanks Again. Fantastic.
Friendship Day Wishes
I truly appreciate this blog post.Much thanks again. Want more.
year, I made plans to finally celebrate the day the way I like best.The Garden of the Gods is just a couple of miles away from my house. I run its trails or cycle its cheap hockey jerseys http://www.dondivamag.com/css.php?id=131 Washington based home and car audio company Rodin. In 2011, AAMP of America acquired American International, giving the company domestic production capabilities and cheap hockey jerseys http://www.dondivamag.com/css.php?id=131 distribution is proud to announce that James Gardner has been retained as the company’s new Asia Pacific Regional Sales Manager. Gardner, an American who has lived in
Thanks a lot for the blog.Really looking forward to read more. Cool.
Good site you have got here.. It’s difficult to find high quality writing like yours nowadays.
I honestly appreciate individuals like you! Take care!!
FDA updates early-feedback program for devices in development
Looking to make good on previous promises to foster rather than hinder innovation in the medical device industry, the FDA has released draft guidance outlining its updated pre-Investigational Device Exemption (IDE) program. According to an item announcing the guidance in the July 13 Federal Register, the updating includes giving IDE a simpler name: the Pre-Submission Program.
The new and improved pre-submission process aims to guide medical device manufacturers interested in getting early indications on the regulatory soundness of products just as, or soon after, they enter companies’ product-development pipelines.
The guidance describes the procedures agency staff will follow at the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) when industry reps and application sponsors request meetings with the agency. It also offers suggestions on meeting reviewers’ requirements for completeness in application documents.
FDA said the draft is open for comment until Oct. 11.
The announcement followed four days after President Obama signed into law the reauthorization of the Medical Device User Fee Act as part of the Food and Drug Safety and Innovation Act. Set to kick in Oct. 1, “MDUFA III” calls for industry to double the user fees it pays FDA in exchange for faster and more consistent reviews.
The announcement preceded the July 14 publication of an investigative report by the New York Times documenting the surprising scope of a previously uncovered operation by FDA officials to spy on their own scientists and review staff. The original story broke in January.
Fill in your details below or click an icon to log in:
You are commenting using your WordPress.com account.
( Log Out /
You are commenting using your Google+ account.
( Log Out /
You are commenting using your Twitter account.
( Log Out /
You are commenting using your Facebook account.
( Log Out /
Connecting to %s
Notify me of new comments via email.
Notify me of new posts via email.