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
Don’t miss our annual conference devoted to higher education and research compliance - Attend the Higher Education & Healthcare Research Compliance Conference June 10–12, 2024 and hear from experienced professionals on a...more
Report on Research Compliance 20, no. 11 (November, 2023) City University of New York (CUNY ) has accused neuroscientist Hoau-Yan Wang, a CUNY faculty member and longtime collaborator with embattled biotech firm Cassava...more
On September 19, FDA released a highly anticipated new draft guidance for industry titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory...more
The U.S. Food and Drug Administration (FDA) recently issued General Considerations for Animal Studies Intended to Evaluate Medical Devices – Guidance for Industry and Food and Drug Administration Staff (fda.gov). Following a...more
A legal fight with People for the Ethical Treatment of Animals (PETA) over the release of documents—including the names of institutional animal care and use committee (IACUC) members—has already cost the University of...more
Get the latest insights in research compliance - The risks and challenges that come with clinical research are unique, as are the abundance of government regulations and enforcers that oversee them. HCCA’s Research...more
Big Boosts to Cybersecurity and Tech Funding in $1.7T Omnibus Bill Signed by Biden - “The bipartisan fiscal 2023 omnibus spending agreement includes $2.9 billion for the Cybersecurity and Infrastructure Security Agency, a...more
On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act for 2023, colloquially referred to as the omnibus funding bill, that includes a similarly expansive and diverse piece of legislation...more
The Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”) was signed into law alongside other reforms to the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) on December 29, 2022, as part of a broader consolidated...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
No, this does not mean what you may think. I believe the best way to protect animals, is to provide for their humane care by their owners. This position is juxtaposed to those who believe animals should be considered...more
Report on Research Compliance Volume 19, Number 9 (September, 2022) - Nina F. Schor, M.D., had been in her job as acting deputy director of NIH’s intramural research program (IRP) for 15 days when she received an email...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
Report on Research Compliance 19, no. 7 (July, 2022) - Given the already “heavy …burden” faced by small institutions and the National Science Foundation's (NSF) low award rate, the Council on Governmental Relations (COGR)...more
A recently enacted Virginia law amending Va. Code § 3.2-6511.2 imposes strict requirements on commercial dog and cat breeders who sell animals “for experimental purposes,” like research. Senate Bill 87, and its counterpart...more
On May 27, 2022, Senate Health, Education, Labor, and Pensions (“HELP”) Committee leaders introduced the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (“FDASLA Act of 2022”), which, if passed,...more
As previously described, NJ bill A1219 would require veterinarians or health officials to notify known pet owners prior to rabies testing of the deceased pet, which currently involves decapitation to provide maximum...more
California recently updated its website providing answers to “Frequently Asked Questions Regarding Veterinarian-Client-Patient Relationship (VCPR)” pursuant to California Code of Regulations (CCR), Title 16, Sections 2032.1,...more
Report on Research Compliance 18, no. 9 (September, 2021) - A former Harvard Medical School and Massachusetts General Hospital (MGH) researcher who was the principal investigator on a 2014 NIH award of $939,495.27 and...more
The Fourth edition of the “Guide for the Care and Use of Agricultural Animals in Research and Teaching,” published by the American Dairy Science Association®, American society of Animal Science and Poultry Science...more
As previously discussed, a Colorado ballot initiative, if sufficient valid signatures are collected, would effectively ban animal agriculture from the State of Colorado if passed. Hard to imagine an initiative that might...more