by Raleigh Malik | Jan 30, 2013
The RAPS Indiana Chapter is hosting a networking event to promote new connections among local regulatory professionals. A BioCrossroads representative will also present an update about the life sciences in Indiana. What: Celebration of Life Sciences in Indiana...
by Raleigh Malik | Jan 30, 2013
The FDA published a final rule entitled Current Good Manufacturing Practice Requirements for Combination Products to provide clarification of cGMP requirements for products that are made up of a combination of devices, drugs and/or biologics. The new guideline applies...
by Raleigh Malik | Jan 30, 2013
Biotech companies are starting to accumulate Big Data, consisting of gene expression profiles, biomarker reliability, patient outcomes and numerous other measurable aspects of drug development. The hope is that the mass amount of data can help streamline R&D....
by Raleigh Malik | Jan 22, 2013
The FDA final guidance, entitled “Refuse to Accept Policy for 510(k)s” outlines the assessment procedures and criteria that FDA intends to use to evaluate 510(K) submissions for administrative acceptance. The guidance contains checklists of the FDA recommended...
by Raleigh Malik | Jan 22, 2013
The regulatory reform plan made by the Chinese State Food and Drug Administration (SFDA) was examined by Ropes & Gray Advisor, Katherine Wang in a recent publication on mondaq.com. The “Reform Plan” aims to improve efficiency of technical reviews and regulatory...
