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...
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...
IMARC Research, a contract research organization (CRO) recently published a list of the “Top Five FDA Warning Letter Findings for Clinical Investigators.” Warning letters are issued when FDA finds objectionable conditions upon inspection. IMARC’s top 5 noted...
