2023, Clinic, Healthcare and Manufacturing

Out At Home: FDA’s Vocal Support of Home Testing but Reluctance to Clear Novel OTC Home Tests

FDA Law

JUNE 22, 2023

FDA hailed its authorization of the Lucira OTC home test for influenza and COVID-19 as “underscor[ing] the Agency’s continued commitment to increase availability of accurate and reliable at-home diagnostic tests” ( April 2023 FDA Update to CDC ). lay users). seeking treatment).

Manufacturing

Manufacturing Clinic IT Transportation

2024 Fall CDRH ELP Proposal Submission Period is Now Open Through September 5, 2023

FDA Law

AUGUST 7, 2023

Through ELP, CDRH staff visit sites that provide formal training and enhance understanding on topics such as how products are developed and how they fit into the larger healthcare system. Submit proposal documents by email to ELP Proposal Submissions by September 5, 2023 at 12 PM ET.

Patient-Centered

Patient-Centered Insurance Manufacturing Provider

To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA

FDA Law

SEPTEMBER 19, 2023

That Policy Statement , issued on September 14, 2023, warns companies that improper listing of patents in the Orange Book could be “ an unfair method of competition in violation of the FTC Act ”. The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the.

Manufacturing

Manufacturing Provider IT Healthcare

As the Calendar Turns, Cybersecurity Remains Key Focus of Digital Health Enforcement

FDA Law

JANUARY 5, 2023

The Playbook is a guide for healthcare delivery organizations to respond to cybersecurity incidents that threaten device function and, potentially, patient safety. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well.

Manufacturing

Manufacturing Patient-Centered Provider Telehealth

FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know

FDA Law

OCTOBER 10, 2023

Non-Clinical Recommendations The draft guidance highlights non-clinical review areas that are generally relevant across 510(k) Implants and offers recommendations for performance data to include in a 510(k) submission. We find that this information is noteworthy for manufacturers to consider.

Manufacturing

Manufacturing Engineering Clinic Provider

Proposed LDT Rule Raises Many Questions but Provides Few Answers

FDA Law

OCTOBER 6, 2023

The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” These words would be added to the definition of “ in vitro diagnostic [IVD] products” in 21 C.F.R. Change to the IVD definition First, the mechanics of the change.

Provider

Provider Manufacturing IT Medical

DEA Concurs: Marijuana Meets Schedule III Criteria

FDA Law

MAY 5, 2024

29, 2023). FDA/HHS Analysis, 2023 FDA/HHS last conducted an eight-factor analysis of marijuana in 2016 and concluded that marijuana continued to meet schedule I criteria. Unlike its 2016 analysis, FDA’s/HHS’ 2023 analysis considers marijuana to have a currently accepted medical use in treatment in the U.S. Letter to U.S.

Medical

Medical Manufacturing Physicals Healthcare Professional

Joint Basis for FDA/HHS Marijuana Rescheduling Recommendation Unveiled

FDA Law

JANUARY 18, 2024

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. By Larry K. 21 U.S.C. § 802(16)(A). 21 U.S.C. § 802(16)(B).

Medical

Medical Physicals IT Healthcare Professional

New Breakthrough Devices Program Guidance: Expanding Opportunities for Medical Product Innovations

FDA Law

OCTOBER 17, 2023

In October 2022, FDA released the draft guidance entitled “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Healthcare,” as previously discussed in our blog.

Medical

Medical Diagnosis Healthcare Clinic

“TAP Dancing” Towards Faster Device Commercialization: CDRH’s Total Product Life Cycle Advisory (“TAP”) Program

FDA Law

JUNE 14, 2023

This is about reducing the time and cost and increasing the predictability of going from concept to commercialization.” – Dr. Jeff Shuren During a presentation at the May 17, 2023 Food and Drug Law Institute (FDLI) Annual Conference, CDRH Director, Dr. Jeff Shuren discussed TAP with enthusiasm.

Manufacturing

Manufacturing Medical Appointment Patient-Centered

Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

GeriPal

MAY 8, 2025

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. James 00:32 Good afternoon.

Illness

Illness IT Patient-Centered Patients

Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

FDA Law

MAY 21, 2024

29, 2023) (“Basis”); NPRM at 44,603. DEA noted that “there is considerable variability in the cannabinoid concentrations and chemical constituency among marijuana samples and that the interpretation of clinical data related to marijuana is complicated.” Basis at 24. NPRM at 44,607. Basis at 7-8; NPRM at 44,614. NPRM at 44,617.

Physicals

Physicals Medical Clinic Emergency Room

Senator Durbin Has Questions About FDA’s “Operational Capacity” to Oversee DTC Prescription Drug Advertising Amid Workforce Reductions – Don’t We All?

FDA Law

JUNE 1, 2025

Senator Durbins letter references a January 2023 study from the Journal of the American Medical Association, which found that more than two-thirds of drugs advertised on television were considered to have low therapeutic value. Its unclear whether there are truly regulatory gaps that require new legislation.

Healthcare Professional

Healthcare Professional Manufacturing Healthcare Utilities

Primary Care Digest

Out At Home: FDA’s Vocal Support of Home Testing but Reluctance to Clear Novel OTC Home Tests

2024 Fall CDRH ELP Proposal Submission Period is Now Open Through September 5, 2023

Trending Sources

To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA

As the Calendar Turns, Cybersecurity Remains Key Focus of Digital Health Enforcement

FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know

Proposed LDT Rule Raises Many Questions but Provides Few Answers

DEA Concurs: Marijuana Meets Schedule III Criteria

Joint Basis for FDA/HHS Marijuana Rescheduling Recommendation Unveiled

New Breakthrough Devices Program Guidance: Expanding Opportunities for Medical Product Innovations

“TAP Dancing” Towards Faster Device Commercialization: CDRH’s Total Product Life Cycle Advisory (“TAP”) Program

Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

Senator Durbin Has Questions About FDA’s “Operational Capacity” to Oversee DTC Prescription Drug Advertising Amid Workforce Reductions – Don’t We All?

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