by Alex Zimmer | Jul 5, 2012
Outsourcing in drug discovery is now said to be a “must”, according to an article by Natalie Morrison on Outsourcing-Pharma.com. With the advancements in biotechnology requiring complex knowledge in both processes and equipment, sources say that the...
by Alex Zimmer | Jun 27, 2012
A new bill, the Sentinel Assurance for Effective Devices (SAED) Act of 2012, introduced by the House of Representatives last month “will allow FDA to more regularly collect, review, and trend adverse event data for medical devices,” according to an article on the FDA...
by Alex Zimmer | Jun 22, 2012
In May, FDA won approval from the Senate for a bill that will renew PDUFA (Prescription Drug User Fee Act) and increase user fees for device companies and drugmakers. Less than a week after being passed by the Senate, the bill also passed through the House of...
by Alex Zimmer | Jun 14, 2012
In May 2012, FDA recently updated its requirements under ICH S6 Guidance for its preclinical testing of biotech drugs. To view this amendment, click here. Along with notable advances and the need to harmonize with international standards, the amendment states that its...
by Alex Zimmer | Jun 13, 2012
The Parenteral Drug Association (PDA) invites you to their 2012 Innovation & Best Practices on Sterile Technology Conference entitled Sterility Assurance for Aseptic Processes and Terminal Sterilization. When: June 18-19, 2012 Where: Conrad Chicago in Chicago,...
