Monthly Publications
In Depth
Subscribe Now
In Depth
coverage of timely
Life Science
Compliance issues
Subscribe Now
Browsing Category
Clinical Research
FDA Responds to Clinical Trials & Part 11 Compliance During COVID-19
The U.S. Food and Drug Administration (FDA) issued updated guidance on how to conduct clinical trials during the COVID-19 public…
Step Therapy: Is it Really More Cost Effective?
Step therapy, the requirement that more cost effective/inexpensive drugs and therapies must be prescribed for a patient before a…
FDA Announces Study on Consumer and HCP Deception Perception
In December 2017, the United States Food and Drug Administration (FDA) announced plans to study whether consumers and healthcare…
FDA Releases Guidance on IND Sponsors
In December, the FDA issued a guidance describing best practices and procedures for timely, transparent, and effective…
FDA Issues Two Proposed Studies on Disclosures for Advertising
Last month, the FDA issued two proposed studies on disclosures for advertising: one for general advertising and another for…
ASCO Removes Restrictions on Researchers’ Conflict of Interest
The American Society of Clinical Oncology (ASCO) has removed all restrictions on author relationships previously in the 2013…
CME Outcomes Increase with Local Participation in Content
Teams from Rockpointe and Potomac Center for Medical Education worked together to draft an article recently published in the…
PhRMA Members Invested $58.8 Billion in R&D in 2015
In 2015, PhRMA member companies invested $58.8 billion in research and development, up 10.3% from 2014. The new R&D data is…
NIH Asks for Input on NCAB Cancer Moonshot Blue Ribbon Panel
Recently, the National Institutes of Health (NIH) released a Request for Information (RFI), asking for both public and…
FDA Guidance: Determining the Extent of Safety Data Collection Needed in…
The FDA finalized a guidance it originally released in 2012 that is aimed to help industry collect safety data in…