Check out this article (login registration is required) entitled “What could proposed changes to the Common Rule mean to sites, sponsors and IRBs” published in the Q2 2013 edition of the Society for Clinical Research Sites’ online journal, InSite. ...
FDA released a new guidance today that reflects items that have appeared across several past guidance documents. It is entitled “Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional Review Board Responsibilities for...
Are you a supplier of raw materials, component parts or finished product to biopharma or medical device companies? The supply chain for pharmaceuticals, biologics and medical device companies are increasingly being audited by their clients and FDA. On July 25, 2013,...
The continuing resolution (CR) bill provides the FDA with an increase of $24 million is the 2013 fiscal year, according to a recent article on outsourcing-pharma.com. The proposed $2.5 billion FDA budget includes $10 million that would allow FDA to add 16 inspectors...
At the end of February, FDA released a final rule, entitled “Additional Safeguards for Children in Clinical Investigations of Food and Drug Administrated-Regulated Products.” The final rule says that FDA will not allow waivers of parental or guardian permission for...
The government’s imposed sequester is set to reduce FDA’s budget by $209 million between now and September 2014, as cited in a recent article on in-pharmatechnologist.com. With the strict budget cuts, the FDA plans to deal with the most relevant objectives. FDA does...
