Monthly Publications
In Depth
Subscribe Now
In Depth
coverage of timely
Life Science
Compliance issues
Subscribe Now
Browsing Category
FDA
Be Careful What You “Like”: Healthcare Industry Should Consider Privacy,…
Social media offers the healthcare industry an opportunity to engage with patients, care givers, and physicians on health care…
FDA: Policies and Procedures for Proposed Trial Design Aimed at Multiple…
In a recent staff memo, Dr. Robert Temple, Deputy Director for Clinical Science at the FDA's Center for Drug Evaluation and…
US v. Caronia, One Year Later: FDA’s Position on Off-Label Promotion…
The Washington Legal Foundation (WLF) recently presented "US v. Caronia, One Year Later: The First Amendment and Federal Oversight…
FDA Office of Regulatory Affairs Operations: Outlines Significant Changes
Last September, we were the first to report on trends relating to changes in leadership at the FDA's Office of Regulatory Affairs.…
OPDP Offers Insight into Enforcement Strategy and Warning Letters
As part of CBI's Pharmaceutical Compliance Congress, Tom Abrams, director of the Food and Drug Administration's (FDA) Office of…
FDA Three Draft Guidances To Regulate Compound Pharmacies – Registration,…
In November of 2013, President Obama signed into law the Drug Quality and Security Act. Recently, with the agency's clarified…
Transforming Professional Medical Education — Role of the FDA
Recently, Douglas C. Throckmorton, MD, the Deputy Director for Regulatory Programs at FDA's Center for Drug Evaluation and…
FDA Releases MedWatcher Reporting for Healthcare Providers, Patients and…
As part of the 20th anniversary celebration of its MedWatch program, we previously reported that the Food and Drug Administration…
The Discrediting OTC Ads – Articles Include Potentially Misleading Claims
A recent study published in the Journal of General Internal Medicine found that as many as "six out of 10 pharmaceutical ads"…
Trends in FDA cGMP Violations
We have previously written that one of the new trends in enforcement in the life sciences industry is the focus the federal…