TRENTON, N.J. (AP) — The Food and Drug Administration issued new warnings Wednesday about the dangers of combining medication for opioid addiction with anti-anxiety medicines and other drugs that also slow breathing and brain activity.
The FDA warned that mixing such drugs can cause difficulty breathing, coma or death, so it should be done with caution.
The agency said…
Posted on September 21, 2017 at 6:02am
In late 2016, the FDA published the revised the Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Guidance for Industry. The aim of this revision is to address Good Manufacturing Practices (GMPs) for a Quality Management System for Active Pharmaceutical Ingredients (API’s). Another of its aims is to help companies ensure that they meet the requirements of API quality and purity characteristics. While replacing Q7A Good Manufacturing Practice…
Posted on September 20, 2017 at 6:26am
About Nitinol-based Medical Devices
Nitinol-based medical devices are made of nitinol, an alloy of nickel and titanium. The use of nitinol-based stents and guidewires has improved procedural outcome. The nitinol alloys are corrosion resistant and are highly accepted in the medical device industry. The global medical devices market has been growing extensively over the years. With increasing investment in research and development (R&D) for manufacturing…Continue
Posted on September 19, 2017 at 6:03am
Some of the functions of medical device manufacturers include:
o Analyzing complaints
o Processing data
o Evaluating nonconformances
o Utilizing other quality data sources.
The main purpose of this analysis, done using appropriate statistical methodology, under §820.100, is to identify the cause of nonconforming products and other quality problems. Time series analysis is one such family of these tools. Also called trending analysis,…
Posted on September 18, 2017 at 6:49am