Monthly Publications
In Depth
Subscribe Now
In Depth
coverage of timely
Life Science
Compliance issues
Subscribe Now
Browsing Category
FDA
Understanding FDA Regulatory Terminology During COVID-19
To update clinicians on the various terminology used by the FDA on treatments related to COVID-19 we have developed this reference…
FDA Eases Some Requirements in the COVID-19 Fight
Recently, the United States Food and Drug Administration (FDA) eased some requirements to allow for more access to masks, personal…
DOJ, FDA and HHS Sound the Alarm About COVID-19 Fraud Schemes
Apparently, scammers are hard at work trying to exploit the COVID-19 pandemic. In the last couple of weeks, multiple agencies…
FDA Halts United States Inspections
On March 18, 2020, the United States Food and Drug Administration (FDA) announced that it was suspending routine surveillance…
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…
HHS Issues Declaration Exempting Some from Liability Related to COVID-19…
The Department of Health and Human Services (“HHS”) recently issued a declaration under the Public Readiness and Emergency…
Pharma Offers Suggestions on Reorganizing OND
Following a public meeting at the United States Food and Drug Administration (FDA) in November 2019, a handful of drug makers sent…
CDER Issues New MAPP For REMS Assessment Reviews
The US Food and Drug Administration (“FDA”) recently issued a Manual of Policies and Procedures (“MAPP”) describing how the Center…
FDA OPDP Working on Two Studies to Better Understand Viewer Comprehension
The United States Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) recently announced that it is…