FDA’s Anti-Infective Drugs Advisory Committee meets April 3 to discuss the safety and efficacy of ciprofloxacin to treat pneumonic plague, as well as development of an animal model of pneumonic plague in African Green Monkeys. It will assess the animal model's relevance to pneumonic plague in humans resulting from exposure to Yersinia pestis in a bioterrorism event.
When agency inspectors enter a facility they want to see the quality control personnel, their qualifications and training records. Firms are not always prepared. Are you?
Chelsea Therapeutics optimistic that ongoing Northera study in Parkinson's disease patients will fulfill FDA's "complete response" request for longer-term efficacy data in orthostatic hypotension.
There has been a seismic shift in the industry since the FDA revised its guidance on process validation a year ago. Often guided by rote formulas and the old “this is how we’ve always done it” mentality, the FDA brought science and risk management to the pharmaceutical manufacturing process. Confronted with this new way of thinking, manufacturers are finding they must reinvent their day-to-day process validation activities. Now is the time to harvest the first year of lessons learned.
"I hope industry is getting the message. The whole issue of supplier control has really risen to the forefront. It has become a big deal for FDA, and that's not going to change." Kim Trautman, Medical Device Quality Systems, GMP Expert, Office of Compliance, FDA
A Headache For Map: Levadex Gets "Complete Response" Letter From FDA The agency raised issues related to the chemistry, manufacturing and controls section of the dihydroergotamine NDA, as well as concerns stemming from inspection of a third-party manufacturing facility, the company says.
