FDA Halts United States Inspections
On March 18, 2020, the United States Food and Drug Administration (FDA) announced that it was suspending routine surveillance…
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March 2020
IHME Creates COVID-19 Projection Tool
The Institution for Health Metrics and Evaluation (IHME) is an independent global health research center at the University of…
CMS Provides Flexibility to Open Payments Reporting Deadline
On March 25th, the Centers for Medicare & Medicaid Services (CMS) recognized that the COVID-19 pandemic may impact the ability…
COVID-19 Physician Groups Call out for More Supplies
COVID-19 is drawing responses from all areas of the healthcare community. This is especially true among health industry trade…
Insys Executives Sentenced
In an update to the shady and criminal dealings that went on within Insys Therapeutics, two additional former executives were…
Mallinckrodt Acthar® Update
Readers may remember the lawsuit that Mallinckrodt PLC subsidiary, Mallinckrodt ARD LLC, filed against the United States…
Pharma and Private Industry Have a Role to Play in COVID-19
David Shaywitz, a physician-scientist and founder of Astounding HealthTech, recently wrote an article about the critical private…
Governor Responses to COVID-19
On March 19, 2020, Maryland Governor Larry Hogan, the chair of the National Governors Association, issued a press release on…
OPDP Issues Warning Letter to Outlook Pharma Over Sponsored Link
On February 21, 2020, the US Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued a Warning…
FDA Guidance on Coronavirus Testing
Recently, the U.S. Food and Drug Administration (FDA) released a guidance that accelerated the ability for certain laboratories to…