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FDA
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:…
FDA to Launch Program Alignment Group to Define Roles and Responsibilities…
According to Regulatory Focus, in response to "unparalleled challenges" posed by advances in science, globalization and product…
FDA Talk about Prescription Month Campaign to Stop Counterfeit and Illegal…
The month of October is also known as the "Talk About Prescription Month," according to the U.S. Food and Drug…
FDA Final Rule for Unique Device Identification System
Right before the government shutdown, the U.S. Food and Drug Administration announced a final rule for the unique device…
FDA Guidance for Mobile Medical Applications
The U.S. Food & Drug Administration (FDA) published its final Guidance for Industry and Food and Drug Administration Staff -…