Tag: FDA
4 Tips for Building a Successful Biotech: Richard Pops of Alkermes at #BIOCEO14
The 16th Annual BIO CEO & Investor Conference opened with a fireside chat between Richard …
BIO Responds to GPhA Citizen Petition on Biosimilars Naming
Last September, the Generic Pharmaceutical Association (GPhA) filed a Citizen Petition with the FDA, requesting …
2013 Novel Drug Approvals
The FDA approved 24 novel drugs last year by our count, in line with average …
Congress Passes Omnibus Spending Agreement
This week, BIO President and CEO Jim Greenwood praised the Congress for passing the fundingbill …
FDA Check-Up: Drug Development and Manufacturing Challenges
I have over 27 years of experience in the biotechnology and pharmaceutical industry. My current …
National Traceability System Moves into Implementation
Last week, President Obama signed into law the Drug Quality and Security Act (H.R. 3204), …
Sequester Threatens FDA Mission
One aspect of sequestration isn’t doing anything to reduce the deficit, but could be delaying …
BIO Patient and Health Advocacy Summit: Patient-Focused Drug Development
Panelists in this morning’s opening session outlined strategies for the FDA to better engage the …
FDA Consumer Update: Advances in Saving Lives with Blood
Every two seconds in the U.S., someone needs a blood transfusion or blood product—people of …
New FDA Final Guidance on Clinical Trial Institutional Review Boards
On Tuesday, August 27th, the FDA finalized its Guidance for Institutional Review Boards, Clinical Investigators …