FDA Law

OCTOBER 10, 2023

We find that this information is noteworthy for manufacturers to consider. FDA encourages manufacturers to submit a pre-submission to discuss the animal study protocol with the Agency before submitting a 510(k) application. programming, monitoring, maintenance). separate patient labeling). separate patient labeling).

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FDA Law

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. 21 U.S.C. § 812 (b)(1).

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FDA Law

MARCH 30, 2022

Earlier this week, FDA issued its Fiscal Year 2023 Budget Justification and related documents. Among the various documents, a document titled “ Executive Summary of FY 2023 Legislative Proposals ” caught our attention. healthcare system. But before we get back to “the Good” again, let’s take a look at “the Bad” and “the Ugly”.

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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.

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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).

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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.

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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In October 2022, FDA released the draft guidance entitled “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Healthcare,” as previously discussed in our blog. FDA will consider if technologies and device features “address unmet needs in these populations” when evaluating criterion one.

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FDA Law

JANUARY 3, 2024

The unapproved drug claims are not, in and of themselves, notable, but it is always interesting when FDA takes a stand against such a large swath of manufacturers and distributors at the same time. And CVM certainly exercises that authority.

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FDA Law

AUGUST 21, 2023

Thus, Defendants argued that FDA already required the warning for pregnancy, rendering the decision to use it during pregnancy to a healthcare professional, and that FDA had considered the risks of in utero exposure and rejected the addition of those risks to the labeling. billion in damages were brought between 1980 and 1986.

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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.

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FDA Law

MAY 21, 2024

29, 2023) (“Basis”); NPRM at 44,603. In 2023, HHS conducted a different approach, a two-part test, to determine whether marijuana has a CAMU. Memorandum for DEA, from HHS, Re: Basis for the Recommendation to Reschedule Marijuana to Schedule III of the Controlled Substances Act, at 9 (Aug.

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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.

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GeriPal

OCTOBER 31, 2024

And when you look at the numbers, actually last year in 2023, even though we’re in a recovery phase, there were more than 75,000 deaths. And because MRNA vaccine someone nimbly manufacture, they can say hey, let’s just make a vaccine based on what’s currently circulating. So I think that’s the way I put it.

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FDA Law

MAY 26, 2025

Attorneys Offices to use the False Claims Act (FCA) to investigate the submission of false claims to federal healthcare programs for non-covered services related to radical gender experimentation. The memo also instructs U.S. And the memo welcomes qui tam whistleblower suits with knowledge of such violations. See United States v.

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