2016, Individual, Manufacturing and Provider

A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.

Manufacturing

Manufacturing Hospital Healthcare Medical

Federal Marijuana Rescheduling: States Get Ready

FDA Law Blog

AUGUST 8, 2024

Governors, state cannabis regulators, law enforcement groups and local governments weighed in, as did marijuana advocates and opponents, marijuana industry associations, Members of Congress, federal law enforcement groups, healthcare and human rights groups, unions and trade associations, and private individuals. 53,688 (Aug. 53,767 (Aug.

Government

Government Medical IT Manufacturing

Answers to the Most Frequently Asked Questions about the Previous Answers to the Most Frequently Asked Questions about Charging for Investigational Drugs

FDA Law Blog

SEPTEMBER 6, 2022

This Draft Guidance, when finalized, will replace the Final Guidance issued just six years ago (the 2016 Guidance). Changes from the 2016 Guidance. What’s new in the new Draft Guidance? Not all that much. The new Q & As (Q21, Q22, and Q23) all concern charging in the context of expanded access.

Clinic

Clinic Manufacturing Patients IT

FDA Publishes Proposal to Redefine the Implied Nutrient Contain Claim “Healthy” Changing Focus to Foods Rather than Nutrients Adding Limits on Added Sugar Content

FDA Law Blog

OCTOBER 5, 2022

In 2015, FDA issued a Warning Letter to Kind LLC because, among other things, the company labeled products as healthy whereas these products provided more saturated fat per serving than permitted by the regulatory definition. It is focused on the nutrients in the food product rather than on it overall nutritional “quality.”.

Provider

Provider Individual IT Manufacturing

The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

FDA Law Blog

OCTOBER 10, 2022

The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains to Clinical Decision Support (CDS) software functions. The guidance provides no rationale for hinging the device status of CDS software on the frequency with which medical information is collected.

Clinic

Clinic Medical Provider Patients

It Takes Three [Components] to Make a Thing Go Riiiiiight – OPDP Challenges Two-Part Ad

FDA Law Blog

JANUARY 26, 2022

Component 1 was a disease state component – identified as “The Journey Forward: Ryan Murphy” or “The Journey Forward: Allysa Seely.” (Note that Allysa Seely is a Paralympian gold medal triathlete, and swimmer Ryan Murphy is a 2016 Olympian and gold medalist.)

IT

IT Education Utilities Patient-Centered

FDA Publishes Draft Guidance on Voluntary Malfunction Summary Reporting Program for Medical Devices

FDA Law Blog

DECEMBER 18, 2022

Generally, FDA’s MDR regulations require device manufacturers to submit Medical Device Reports (MDRs) for individual reportable malfunctions within 30 calendar days of the manufacturer becoming aware of the malfunction. In that letter, FDA stated that it would “permit manufacturers.

Medical

Medical Manufacturing Individual Provider

FDA Issues Draft Guidance Distinguishing Remanufacturing from Servicing

FDA Law Blog

JUNE 24, 2021

In 2016, FDA opened a docket seeking comments on “service, maintenance, refurbishment, and alteration of medical devices” by third parties (see our blog post here ). In contrast, a device servicer is not a device manufacturer and, therefore, need not comply with the QSR.

Manufacturing

Manufacturing Medical Provider IT

DEA Concurs: Marijuana Meets Schedule III Criteria

FDA Law Blog

MAY 5, 2024

Houck — The Associated Press reported on Tuesday following confirmation by five anonymous individuals with knowledge that the Drug Enforcement Administration (“DEA”) is moving to reschedule marijuana from schedule I to the less stringently controlled schedule III. Schedule III substances do not require manufacturing quotas.

Medical

Medical Manufacturing Physicals Healthcare Professional

A Review of H5N1

Alabama Academy of Family Physicians

FEBRUARY 20, 2025

Since 2016, HPAI H5N1 has been detected in wild birds in the United States during screening efforts by wildlife authorities. There have been a few severe cases and one individual died with H5N1 infection. Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed.

Patient-Centered

Patient-Centered Provider Manufacturing Screening

Drug Pricing Reform Gathers Steam (Part 2)

FDA Law Blog

SEPTEMBER 14, 2021

The most far reaching drug pricing provision of Subtitle E is an amendment to the Social Security Act to establish a Fair Price Negotiation Program applicable to Medicare Parts B and D as well as group and individual health plans in the commercial market. the amount Part D plans pay pharmacies for the drugs).

Manufacturing

Manufacturing Insurance Government Patients

Drug Pricing Reform Gathers Steam (Part 1): White House Drug Pricing Plan Offers Laundry List of Existing Democrat Priorities

FDA Law Blog

SEPTEMBER 13, 2021

A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate.

Manufacturing

Manufacturing Supply Chain Patient-Centered Utilities

Primary Care Digest

A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

Federal Marijuana Rescheduling: States Get Ready

Trending Sources

Answers to the Most Frequently Asked Questions about the Previous Answers to the Most Frequently Asked Questions about Charging for Investigational Drugs

FDA Publishes Proposal to Redefine the Implied Nutrient Contain Claim “Healthy” Changing Focus to Foods Rather than Nutrients Adding Limits on Added Sugar Content

The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

It Takes Three [Components] to Make a Thing Go Riiiiiight – OPDP Challenges Two-Part Ad

FDA Publishes Draft Guidance on Voluntary Malfunction Summary Reporting Program for Medical Devices

FDA Issues Draft Guidance Distinguishing Remanufacturing from Servicing

DEA Concurs: Marijuana Meets Schedule III Criteria

A Review of H5N1

Drug Pricing Reform Gathers Steam (Part 2)

Drug Pricing Reform Gathers Steam (Part 1): White House Drug Pricing Plan Offers Laundry List of Existing Democrat Priorities

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