Biosimilar User Fee Act (II) Performance Goals Letter Issued
The United States Food and Drug Administration (FDA) recently released its performance goals and procedures for fiscal years 2018…
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FDA Announces Draft MDUFA Agreement
On August 22, FDA and representatives from the medical device industry and laboratory community announced an agreement in…
ACCME Releases Menu of New Criteria for Accreditation with Commendation
The Accreditation Council for Continuing Medical Education (ACCME) recently announced a Menu of New Criteria for Accreditation…
FDA Criticized for Moving Too Slowly
The Food and Drug Administration (FDA) is a frequent target of Congressional critics, sometimes for good reason. Earlier this…
FDA “Revolving Door” Gets Slammed
Last week, several news outlets wrote articles about the “revolving door” at the United States Food and Drug Administration (FDA),…
ClinRegs Upgrades Are Here!
Longtime readers may remember when the National Institute of Allery and Infectious Diseases (NIAID) released the ClinRegs website,…
FDA Announces Dates for Public Hearing on Off-Label Communication…
In late August, the United States Food and Drug Administration (FDA) announced that it will hold a two-day public hearing November…
Webinar: Open Payments Retrospect and Looking Forward
On October 13, 2016, qordata will be hosting a webinar, “Retrospect and Looking Forward: A Review of Two Full Years of Open…
Prescriber Education Campaign on Opioids Launched
We have been hearing for years about the opioid crisis our country is facing, a crisis that was partially brought about by abuse…
Novartis CEO Predicts Shift in Drug Pricing, Post-Election
In an interview with the Financial Times, Joe Jiminez, CEO of Novartis, predicts that November’s election may “trigger a sea…