The Informed Consent Process and the changes introduced to the Declaration of Helsinki in 2013. Part 2 of 5

Part 2: General Modifications

Declaration of HelsinkiIn the October 2013 revision, some definitions and statements that affect the informed consent process are explained in more detail which undoubtedly is a consequence of the current progresses attained in the clinical development activity.

These re-definitions in the General Principles of the Declaration are aimed to improve the Continue reading

FDA Provides Notice of Planned Withdrawal, Revision of Aged Guidance Documents

In September 2000, FDA issued the final rule “Administrative Practices and Procedures; Good Guidance Practices” (GGP). One aspect of the GGP regulation explains that the FDA will periodically review existing guidance documents to determine whether they need to be changed or withdrawn.

As such, the Center for Drug Evaluation and Research (CDER) has launched an initiative to review draft guidance documents published before 2010 in an effort to decide which guidances to withdraw, revise, or finalize Continue reading