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 decline, according to a new report issued FDA. The number of medical device-related warning letters dipped to 121 in CY2 [...]
FDA Touts Improved IDE Review Stats
Michael Causey, Editor-in-Chief,Association of Clinical Research Professionals Ironically, FDA is sometimes wary of issuing guidances out of concern it will appear it is imposing new rules that will [...]
GAO Report Finds Steady Medical Device Profit Climb – Especially the Big Boys
Michael Causey, Editor-in-Chief,Association of Clinical Research Professionals A new Government Accounting Office (GAO) report designed to shed light on what impact the medical device tax will have [...]
Obama Veto Threat Looms Over Medical Device Tax Battle
Michael Causey, Editor-in-Chief,Association of Clinical Research Professionals With medical industry trade groups and many House and Senate members lined up on one side determined to repeal the medi [...]
Quality Takes Time, FDA’s CDER Reminds Drug Makers
Scholars still debate how long it took to build the Great Wall of China, but it’s generally agreed it was built in stages between the Fifth Century B.C. and the Sixteenth Century A.D. The Great Pyrami [...]
FDA IDE Guidance Offers Industry Important Clarity
In its August 19 guidance for Investigation Device Exemption (IDE) Clinical Investigators, the FDA attempts to better outline its thought process for reviewing, accepting, accepting with conditions or [...]
Partnership of Productivity Tools Will Allow You to Focus More on Creating Quality Products
Dennis Payton, Vice President of Product Marketing and Development, Expandable Software, Inc. In 1908, the first Model T was created and more than 15 million were sold through mid-1927, proving that [...]
