Quality Management Efforts: 2017 CDER Guidance Agenda Impact
Quality management efforts could be impacted by what appears to be an aggressive guidance agenda for 2017 from the Center For Drug Evaluation and Research (CDER). Former FDA Chairman Robert Califf For [...]
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’s CDER Unveils Ambitious 2015 Wish List
The holidays came a little early for the folks at the Center for Drug Evaluation and Research (CDER). They just released their sometimes optimistic, but always enlightening guidance wish list and over [...]
CDRH Report: Quality Management Insights For Medical Device Manufacturers
FDA's Center for Devices and Radiological Health (CDRH) provided a glowing self-assessment in a recent report. The CDRH met its 2016 strategic objectives for several initiatives pertaining to medical [...]
Increased QMS Compliance Inspections For International Life Science Manufacturers
International QMS compliance inspections of pharmaceutical and medical device manufacturers by the FDA and MHRA are on the rise. FDA & MHRA Increase Inspections Both the Food and Drug Administrati [...]
Tougher Quality Management Enforcement By FDA In 2017
Quality management, always an FDA focus during inspections, could become even more important in 2017 as FDA priorities take shape. Quality Management Efforts Will Be Impacted In 2017 In late December, [...]
Risk Management + Quality Metrics Reporting: Revised FDA Guidance
Risk management remains a strong focus of the FDA. A revised FDA guidance offers new details and hones the scope previewing the agency's pilot test of a risk-based system to track pharmaceutical manuf [...]
Improving FDA Reviews of Combination Products
The FDA and Intercenter Consultations Just a few short weeks ago, Robert Califf, the US Food and Drug Administration (FDA) Commissioner nominee, endorsed an internal report that provided recommendati [...]
FDA’s Action Plan Demands Some Industry Action, Too
“The following Pharmaceuticals FY 2015 Action Plan (the Action Plan), developed by the Office of Regulatory Affairs (ORA), the Center for Drug Evaluation and Research (CDER), and the Center for Veteri [...]
FDA’s CDRH Guidance Tempers 2015 Goals with a Dash of Pessimism
Unlike its sister Center for Drug Evaluation & Research (CDER), CDRH’s (Center for Devices & Radiological Health) new proposed guidance development and goals for 2015 reminds industry not to [...]