Monthly Publications
In Depth
Subscribe Now
In Depth
coverage of timely
Life Science
Compliance issues
Subscribe Now
Browsing Category
FDA
FDA Draft Guidance – Oversight of Clinical Investigations: A Risk…
The Food and Drug Administration (FDA) announced the publication of a draft guidance titled, “Oversight of Clinical…
FDA Revises Guidance on Marketed Unapproved Drugs – Enforcement Actions…
This week, the Food and Drug Administration (FDA) announced a revision to its 2006 guidance titled “Marketed Unapproved Drugs--…
Study Shows Adherence to FDA Advertising Guidelines Are in the Eye of the…
Advertising is a crucial component of pharmaceutical industry marketing around the world and plays an important role in educating…
ACRE Releases Statement on Enhancing FDA Advisory Committee Recruitment
The Association of Clinical Researchers and Educators (ACRE) today announced its support for reforms to the Food and Drug…
Drug Shortages Potential Causes Stricter FDA, Price Controls and Policies…
Over the past two years shortages have developed for over 180 drugs, including cancer treatments. According to a recent article…
FDA and Industry Agree on Generic Drug User Fee to Contribute to Faster…
According to a recent article in the New York Times, “more than 80 percent of the active ingredients for drugs sold in the United…
Institute of Medicine Report Medical Devices and the Public’s Health: The…
Today, the Institute of Medicine (IOM) Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process released…
c
On Friday of this week, the Institute of Medicine will release their recommendations on the FDA 510K process. The IOM…
US House Energy and Commerce PDUFA Hearing: Transformation of the FDA
Earlier this month, the House of Representatives Energy and Commerce Subcommittee on Health held a hearing on the reauthorization…
Advertising Coalition Responds to FDA Examination of Online…
As we noted earlier this month, the Food and Drug Administration (FDA) published a Notice for Comment regarding the Examination of…