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Strengthening ClinicalTrials.gov

A notice published in the Federal Register for Wednesday, September 26, 2012 reported the delegation of authority to the Commissioner of Food and Drugs to police[…]

German drug firm apologizes for harm caused by thalidomide

Harald F. Stock, PhD, Chief Executive Officer of Grünenthal GmbH - the German pharmaceutical company that developed thalidomide in the late 1950s - recently offered a public apology to those[…]

German drug firm apologizes for harm caused by thalidomide

Harald F. Stock, PhD, Chief Executive Officer of Grünenthal GmbH - the German pharmaceutical company that developed thalidomide - recently offered a public apology to those who were harmed by[…]

FDA announces permanent debarment orders for clinical trial misconduct

Today’s Federal Register announces the permanent debarment by FDA of two individuals who worked for the Lee Research Institute in Lenexa, KS, in response to felony[…]

FDA and NIH funding in jeopardy

FDA and NIH could both face significant funding cuts if the executive branch is unable to reach an agreement with Congress on required spending cuts.[…]

Tips for handling problem PIs

Do you recognize any of these PIs? Dr. Studies, AKA Dr. “We Can Do That” Dr. Enrollment, AKA Dr. “I Want to Enroll an Incarcerated Schizophrenic Patient[…]

FDA issues draft guidance on prospective assessment of suicidal ideation and behavior in clinical trial participants

FDA recently issued a draft guidance addressing the issue of suicidal ideation and behavior that emerges during clinical trials of investigational drugs and biologics. The guidance[…]

FDA issues draft guidance on prospective assessment of suicidal ideation and behavior in clinical trial participants

FDA recently issued a draft guidance addressing the issue of suicidal ideation and behavior that emerges during clinical trials of investigational drugs and biologics. The guidance[…]

Public workshop on FDA clinical trial requirements

FDA and the Society of Clinical Research Associates (SoCRA) will co-sponsor a public workshop to be held November 14-15, 2012 in Baltimore, MD. The target[…]

Public workshop on FDA clinical trial requirements

FDA and the Society of Clinical Research Associates (SoCRA) will co-sponsor a public workshop to be held November 14-15, 2012 in Baltimore, MD. The target[…]