Laboratories in the United States are facing a major regulatory landscape shift.
The U.S. Food and Drug Administration (FDA) has finalized a new rule ending its historical blanket enforcement discretion over laboratory...more
As of Monday March 4, 2024—just three months after the end of its comment period on December 4, 2023—FDA’s rule on regulation of laboratory developed tests (“LDTs”) as medical devices is under review by the Office of...more
In a last minute push before an anticipated government shutdown, FDA put down its marker for moving forward toward regulation of lab developed tests (“LDTs”). Unlike past proposals from FDA and Capitol Hill, FDA has taken a...more
Throughout this series, we've talked about the growth of the direct access testing industry and the types of models developed to support the businesses that are using that type of testing.
We've covered reimbursement...more
On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July...more
9/6/2023
/ Clinical Trials ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Informed Consent ,
IRB ,
Life Sciences ,
Medical Research ,
New Guidance ,
Pharmaceutical Industry ,
Scientific Research
As discussed in our June Insight, earlier this year FDA publicly announced its development of a proposed rule that would expressly define laboratory developed tests (“LDTs”) as medical devices and subject them to the agency’s...more
The Food and Drug Administration (“FDA” or “agency”) intends to issue a notice of proposed rulemaking in August 2023 that will “make explicit” that laboratory developed tests (LDTs) are devices under the federal Food, Drug,...more
On May 2, 2023, the U.S. Food and Drug Administration (FDA) took additional steps to support the use of decentralized clinical trials (DCTs) by releasing a new draft guidance titled “Decentralized Clinical Trials for Drugs,...more
A complex landscape of state laws overlays the direct access testing model, ranging from physician order requirements, such as telemedicine standards and the corporate practice of medicine doctrine, to specimen collection...more
When analyzing the life cycle of any health care product, a key component to consider is how much the product will cost and who will pay for it. What unique challenges do direct access tests (DATs) pose when it comes to...more
What are the various factors impacting stakeholders in the direct access testing industry?
By the end of this four-part series on direct access laboratory testing, listeners will have gained insight into how to navigate the...more
The Dobbs v. Jackson Women’s Health Organization decision, which effectively removed the federal constitutional protections for abortion, triggered a series of changes for health care providers and patients alike across the...more
Since the passage of the Medical Device Amendments of 1976, FDA has regulated in vitro diagnostic (IVD) tests as medical devices, subject to a full suite of FDA requirements. During that time, FDA has also asserted that it...more
This term, the Supreme Court of the United States is set to rule in a Medicare reimbursement case that has sparked a fresh look at the historical deference often granted to agencies and whether it should remain, be modified,...more
Federal and state cannabis regulation and enforcement appear to be moving in different directions. While the Food and Drug Administration ("FDA") has broadened its net to target businesses making claims that their products...more
6/3/2021
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Decriminalization of Marijuana ,
Drug Testing ,
FDA Warning Letters ,
Federal v State Law Application ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Recreational Use ,
Retailers
This Diagnosing Health Care episode dives into the status of the Food and Drug Administration’s (“FDA’s”) plan for regulating cannabis and cannabis-derived products and what actions the agency has taken recently to make...more
FDA took two important steps last week to clarify the regulatory landscape for cannabis products, including CBD products. First, FDA issued a draft guidance on Quality Considerations for Clinical Research Involving Cannabis...more
7/29/2020
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Clinical Trials ,
Controlled Substances Act ,
DEA ,
Draft Guidance ,
Farm Bill ,
Food and Drug Administration (FDA) ,
Investigational New Drug Application (IND) ,
Marijuana ,
OMB
This Diagnosing Health Care episode focuses on the growing opportunity for providers to integrate telehealth into their practice through a compliant and forward-thinking approach. The episode is hosted by Megan Robertson and...more
The cannabidiol (“CBD”) consumer product marketplace is booming. And, while FDA has maintained its position that CBD, even hemp-derived CBD, may not be included as an ingredient in conventional foods or dietary supplements,...more
7/14/2020
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Dietary Supplements ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Marijuana ,
Marketing ,
Medical Foods ,
Plant Based Products ,
Warning Letters
As an update to our prior blog post, on April 20, 2020 FDA announced the authorization of the first COVID-19 test for home collection of specimens. ...more
On Friday, March 27, 2020, FDA issued an update to previous guidance titled, “FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic” (the “Guidance”), adding an Appendix with ten...more
On March 16, 2020, FDA finalized its guidance titled Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (the “Policy”). The Policy includes information and recommendations to assist...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
Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more
12/4/2019
/ Adverse Events ,
Comment Period ,
Direct to Consumer Sales ,
Draft Guidance ,
Enforcement Actions ,
Enforcement Authority ,
FDA Warning Letters ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Homeopathic Remedies ,
Marketing ,
New Guidance ,
Pharmaceutical Industry ,
Product Labels ,
Public Health ,
Regulatory Oversight ,
Retail Market ,
Safe Harbors
On July 31, 2018, the Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services released a portfolio titled “Vulnerabilities in the Medicare Hospice Program Affect Quality Care and Program...more