Monthly Publications
In Depth
Subscribe Now
In Depth
coverage of timely
Life Science
Compliance issues
Subscribe Now
Browsing Category
FDA
FDA Draft Guidance on Transparency and Advisory Committees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…
PDUFA 2012 – Background From PhRMA’s Perspective
In 2012 Congress will be revisiting Prescription Drug User Fee Act (PDUFA). In an effort to prepare the FDA is asking for comments…
FDA – Proposed DTC Advertising Guidance – Clear, Conspicuous and Neutral
The Food and Drug Administration (FDA) has recently issued proposed guidance for direct to consumer television and radio ads as…
Building a Comparative FDA May Not Lead to Effectiveness
A recent article in the Journal of the American Medical Association (JAMA) discusses how to “Build Comparative Efficacy and…
Congressional Hearing on Drug Safety: an Update from the FDA
Last week, The House Committee on Energy and Commerce, Subcommittee on Health held a hearing on “Drug Safety: An Update from the…
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…
Fox Stossel Show: Hands Off My Healthcare
Tonight at 8:00pm and 11:00pm EST on the Fox Businesses Channel, John Stossel, host of "Stossel" on the Fox Business…
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…