Tag: FDA
BIO Calls on Appropriators to Fully Fund FDA
BIO issued letters today encouraging support for programs and initiatives of critical importance to our …
“No Need to Label GMOs” Says FDA
The Nation’s Leading Regulatory Body on Food Safety Reaffirms Safety of GMOs On March 28, …
FDA: Vaccines a Critical Tool in Protecting and Promoting Public Health
Yesterday, Dr. Karen Midthun of the FDA wrote about the important role of vaccines in promoting public …
U.S. Rep. Charlie Dent Discusses PDUFA and NIH Funding at #BIOCEO14
During the 16th Annual BIO CEO & Investor Conference, U.S. Representative Charlie Dent of Pennsylvania, …
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), …