FDA Transparency Initiative: Draft Disclosure Policies
In addition to the recently published Nation Institutes of Health (NIH) transparency Guidelines, the Food and Drug Administration…
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Food and Drug Administration
FDA Draft Guidance on Transparency and Advisory Committees
This week, Dr. Margaret A. Hamburg, Commissioner of the Food and Drug Administration (FDA), sent a letter to colleagues and staff…
FDA Educates Industry on Development of Orphan Drugs
In the complex and expensive world of research and development for drugs, there are therapies for conditions known as “orphan…
GAO Recommends the FDA to Strengthen Investigation Oversight
Within the Food and Drug Administration (FDA) is the Office of Criminal Investigations (OCI), which investigates individuals and…
Letters from Grassley: FDA to Clarify Policies on Medical Devices
This week, Senator Charles Grassley (R-IA), ranking member of the Senate Finance Committee, issued a press release asking the Food…
Five Part Podcast Series on FDA Features John Kamp of Coalition for…
A new five-part Podcast series was recently announced by Med Ad News editors Steven Niles and Joshua Slatko. The series will…
FDA Official Cleared of Conflict Allegations in Heparin Contamination Case
Last week Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA was cleared of a conflict of interest…
GAO to FDA: Action Needed to Improve Timeliness on Clinical Investigator…
The Government Accounting Office ("GAO") published a new report on the oversight of clinical investigators titled,…
FDA Issues Draft Guidance on Medical Device User Fee and Modernization Act
The Food and Drug Administration (FDA) gave notice to the public of a Proposed Guidance Development on the Web for the Medical…
Allegan Sues FDA to Allow Scientifically Backed Off Label Promotion
According to a recent report, “Allergan has filed a federal lawsuit seeking a court ruling that would allow it to share relevant…