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FDA
Increased Clinical Trial Transparency in US and Abroad
Over the past several months, the European Medicines Agency (EMA) has been focusing on making the results and data of clinical…
FDA and ONC Work Together to Spur Innovation in Mobile Health Technologies
The US government's Health Information Technology (HIT) Committee of the Office of the National Coordinator (ONC) has called on…
NIH, FDA and Academic Institutions: Announce Industry Academic…
Several recent announcements have discussed new industry-academic collaborations as well as new funding opportunities to help…
FDA: Supplemental Applications Proposing Labeling Changes for Approved…
The Food and Drug Administration (FDA) wants to cut down the time it takes patients and doctors to get new safety information…
Using FDA Big Data and Electronic Health Records to Improve Drug Safety
Recent research, published in the journal Science Translational Medicine, found a method to help address adverse events from…
FDA Clearance of Medical Devices Through 510K (FDA and HHS-OIG Reports)
The U.S. Department of Health and Human Services, Office of Inspector General issued a report: "FDA's Clearance of Medical Devices…
FDA: The Differences with Pharmaceutical and Device Promotion Standards
Over the years we have noted in our coverage of FDLI's Enforcement and Litigation Conference that DOJ and other officials…
FDA OPDP: Announces Accredited CME Course for Bad Ad Program
In May 2010, the Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) launched the Bad Ad program.…
FDA Draft National Adverse Event Plan
Adverse drug events (ADEs) have been defined as an injury resulting from medical intervention related to a drug. ADEs can occur in…
FDA: A Parents’ Guide to Kids’ Vaccines
The FDA has unveiled a "A Parents' Guide to Kids' Vaccines" on its website. The website outlines several key areas:…