Blog
FDA final Rule Rejects Parental Waivers and Final Document
At the end of February, FDA released a final rule, entitled “Additional Safeguards for Children in Clinical Investigations of Food and Drug Administrated-Regulated Products.” The final rule says that FDA will not allow waivers of parental or guardian permission for...
Sequester hits hard at FDA
The government’s imposed sequester is set to reduce FDA’s budget by $209 million between now and September 2014, as cited in a recent article on in-pharmatechnologist.com. With the strict budget cuts, the FDA plans to deal with the most relevant objectives. FDA does...
Save the Date: June 12, 2013, St. Vincent Health Research Symposium
St. Vincent Health is hosting its annual research symposium with breakout topics to include regulatory affairs, women's health and family medicine. What: St. Vincent's 9th Annual Research Symposium When: June 12, 2013 Time: 7:15am- 4:45pm Where: Lily Conference Center...
Pearl Expansion mentioned on NWI.com
Guest commentator and president of the Greater Indianapolis Chamber of Commerce, Scott Miller cited the news of Pearl’s expansion as a sign of the growing life science industry in Indiana in a recent article on nwi.com. Miller’s article describes the current state of...
Save the Date: March 27th, IMDMC Event
The legal implications of the Sunshine Law Final Rule will be discussed by a panel of experts at the March Indiana Medical Device Manufacturer's Council (IMDMC) March event. Topic: Sunshine Law Final Rule: How to Ensure Compliance When: March 27, 2013 Where: ...