FDA Eases Up a Bit on Enforcement Gas Pedal as Warning Letters Decline
Medical device warning letters and domestic inspections continue to show a slow [...]
5
11, 2015
3
11, 2015
Improving FDA Reviews of Combination Products
The FDA and Intercenter Consultations Just a few short weeks ago, Robert Califf, [...]
29
10, 2015
FDA Guidance Answers (Some) Medical Device Cybersecurity Concerns
A new FDA guidance calls on the medical device community to be more proactive wh [...]
14
10, 2015
FDA Inspectors Leave Calling Cards For Medical Device Manufacturers Nationwide
Our latest round of warning letters emphasize the importance for medical device [...]
29
09, 2015
FDA Touts Improved IDE Review Stats
Michael Causey, Editor-in-Chief,Association of Clinical Research Professionals [...]
22
09, 2015
Got Patient Care Ideas? FDA Wants to Hear Them
As promised, the FDA just announced its first Patient Engagement Advisory Commit [...]
14
09, 2015
FDA’s New 510(k) Guidance Emphasizes Software as Device Factor
The path to medical device commercialization requires FDA approval, which most o [...]
25
08, 2015
FDA Pilot Program Encourages Quarterly Malfunction Summary Filings
FDA will be taking applications starting Sept 1, 2015, looking for makers of cla [...]
19
08, 2015
FDA Takes GUDID Offline: Security breach? Or Proactive Measures?
FDA detected a "security vulnerability" earlier this month that spooked it enoug [...]
17
08, 2015
US Drug Shortage Hits Patients, Pharmacies the Hardest
Patrick Stone, President, TradeStoneQA The corner drug store is not currently [...]
