Pearls of Wisdom
FDA finalizes 510(k) refuse-to-accept policy
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...
China announces regulatory reform plan
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...
European Medicines Agency plans to increase drug maker fees
The European Medicines Agency (EMA) released its 2013 budget earlier this month per a recent article published in in-ParmaTechnologist.com. The budget includes a 4% increase on its expenditures and projects other potential funding sources (e.g. EU) will increase...
FDA releases final guidance of eCopy Program
The FDA recently published a final guidance, “eCopy Program for Medical Device Submissions” to describe the new electronic (eCopy) Program for medical device submissions. The guidance, effective Jan. 1, requires eCopy submission for most types of device applications,...
FDA partners with Medical Device Innovation Consortium
The FDA joined the Medical Device Innovation Consortium (MDIC) in the first public-private partnership to promote medical device regulatory science. MDIC is an independent, non-profit corporation created by CDRH and LifeScience Alley (LSA), a Minnesota-based...