ASSURX
- We've heard from inside sources there are more public comments waiting to be posted re: eMDR draft guidance.42 minutes ago from web
- Speaking of eSubmissions, Comment period ends 11/19/09 on eMDR submissions draft guidance (FDA/CDRH) 44 minutes ago from web
- FDA CDRH AS2 ESG (electronic submissions) reaches highest ever in Oct - 2,529. Med Device companies coming on board slowly but surely. about 1 hour ago from web
- Foreign drug facility inspections [by FDA] to increase to 924, up from 600 in FY09. about 1 hour ago from web
- FDA to ratchet up overseas pharma oversight by one third for FY2010 and double its inspections. about 1 hour ago from web
- This week's Mark's Memo just published. about 1 hour ago from web
- 510K applications declined by 19% while appr time increased by 2% along with added FDA personnel (@)10:42 AM Nov 3rd from web
- RT @ Exclusive: FDA lags on 510(k) approvals 10:40 AM Nov 3rd from web
- This week's Mark's Memo just posted - FDA Regulatory Updates and News. 9:18 AM Nov 3rd from web
- @ Yes, I see it and the link works! Thanks! 10:27 AM Oct 29th from web in reply to skypen
- Only one device company has submitted a comment regarding mandatory eMDR submissions. Grove Medical in FL 10:25 AM Oct 29th from web
- Comment period ends 11/19/09 on eMDR submissions draft guidance (FDA/CDRH) 10:20 AM Oct 29th from web
- RT @ Show your support for FDA public hearings on social media on . Secure your spot, RT this @9:21 AM Oct 29th from web
- RT @ Social Media Best Practices for Pharma Are Needed, Whatever Happens at FDA 8:21 AM Oct 29th from web
- RT @ Interesting regulatory article 11:20 AM Oct 28th from web
- FDA's CDRH electronic submissions (via AS2 ESG) doubled in September (2,448) - YTD 12,895. Already triple the total for all of 2008. 9:43 AM Oct 28th from web
- RT @: Expect FDA Social Media Draft Guidance Before End of 2010. Pharma Marketing Blog post: 8:24 AM Oct 28th from web
- RT @ New article: The Future of Quality Systems: A Need For Action 8:03 AM Oct 28th from web
- All seem to be same: "Failure to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17" 7:56 AM Oct 28th from web
- Lots of FDA MDR warning letters issued to Lasik facilities in the past two weeks. 7:55 AM Oct 28th from web
|
- Name ASSURX
- Location California
- Web http://www.assurx...
- Bio Quality Management, Risk, & Regulatory Compliance Software, #quality, #compliance #software, #saas
|
