Medical Device Legal News with Sam Bernstein: Episode 9
HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day comprehensive training program with a focus on the topics and issues that affect research compliance professionals. Our faculty of experienced...more
Given its growing role as the “pharmacy to the world,” FDA Commissioner Robert Califf, M.D., recently took a trip to India and offered some of his (and FDA's) views upon his return. During his visit, Commissioner Califf met...more
The US Supreme Court rules that, under the Federal False Claims Act (FCA), the knowledge and subjective beliefs of a defendant at the time a false claim was submitted are determinative, and post hoc objectively reasonable...more
The U.S. Food and Drug Administration (FDA) recently published a draft of its updated Good Clinical Practice (GCP) guidance for modernizing clinical trials. The draft guidance will be open for public comment for 60 days from...more
On March 15, the U.S. Food and Drug Administration (FDA) issued revised draft guidance summarizing how it intends regulate the use of electronic systems, records, and signatures in clinical investigations to account for...more
HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day comprehensive training program designed to help attendees increase their ability to manage effective compliance programs. Our faculty of experts provides...more
HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day intensive training program designed to help attendees increase their ability to manage effective research compliance programs. Our faculty of experts...more
Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more
The U.S. Food and Drug Administration’s (FDA’s) Office of Bioresearch Monitoring Operations (OBIMO) oversees domestic and foreign agency field inspections for clinical and non-clinical research. In particular, OBIMO manages...more
Consent Forms (ICF) to include an explicit reference as to the possibility that EU inspectors would have access to medical records and personal data of clinical trial participants....more
As the COVID-19 pandemic continues to alter ways of life across the globe, clinical trials must be adapted for participant safety while maintaining accuracy in the midst of the ongoing crisis. In September 2020, the U.S. Food...more
Late last week, the U.S. Food and Drug Administration (FDA) announced it approved the use of spun synthetic swabs similar to Q-tips for use in testing for COVID-19....more
Our annual Clinical Practice Compliance Conference provides information about the latest government initiatives related to physicians and clinics, and physician integrity trends. Unite with your colleagues to discuss...more
FDA has issued a new Guidance to address certain challenges to clinical trials during the COVID-19 pandemic. This Guidance takes effect immediately and applies to clinical trials of drugs, biologics, and medical devices....more
On Wednesday, March 18, the U.S. Food and Drug Administration published the guidance “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic."...more
On Wednesday, March 18, 2020, the Food and Drug Administration (“FDA”) issued a guidance document titled, “FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic” (the “Guidance”)....more
As the coronavirus (COVID-19) pandemic continues to grow, the US Food and Drug Administration (FDA) on March 18 issued a guidance document titled FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19...more
The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more
Due to the COVID-19 emergency and the consequent lockdown that is affecting non-essential services in Italy, including some health care services, on March 12, 2020 the Italian Medicines Agency ("AIFA") issued a Guidance,...more
The European Medicines Agency (EMA) issued a qualification opinion following a request concerning proprietary eSource DDC (Direct Data Capture) technology. This technology allows the capture of clinical study source data...more
At the close of 2018, the Advanced Medical Technology Association (AdvaMed) released an updated version of its Code of Ethics governing medical technology manufacturers in their interactions with health care professionals...more
On 23 May 2018, the European Medicine Agency (EMA) launched a public consultation for a draft guideline concerning the responsibilities of trial sponsors for handling and shipping of investigational medicinal products for...more