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.

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FDA Law Blog

JANUARY 18, 2022

In May 2016, FDA released a draft guidance document titled “Technical Considerations for Additive Manufactured Devices” (see our blog post on the draft guidance here ), which was finalized in 2018 (see our blog post on the final guidance here ). use in education, construction, art, and jewelry). products intended for medical purposes).

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Medical Manufacturing Healthcare Government 98

FDA Law Blog

JANUARY 18, 2022

In May 2016, FDA released a draft guidance document titled “Technical Considerations for Additive Manufactured Devices” (see our blog post on the draft guidance here ), which was finalized in 2018 (see our blog post on the final guidance here ). use in education, construction, art, and jewelry). products intended for medical purposes).

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Medical Manufacturing Healthcare Government 75

FDA Law Blog

JANUARY 18, 2023

Recall that CMS is required to negotiate and publish the 2016 maximum fair price for 10 high expenditure, single source Part D drugs by September 1, 2024. Upcoming CMS Guidance CMS provides a list of topics on which it plans to issue guidance. The Agency has promised it will provide comment periods for each guidance.

Manufacturing 59

Manufacturing IT Provider Government 59

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This Draft Guidance, when finalized, will replace the Final Guidance issued just six years ago (the 2016 Guidance).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 What’s new in the new Draft Guidance?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.

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Clinic Manufacturing Patients IT 52

FDA Law Blog

APRIL 19, 2021

The Court decision limiting FDA’s discretion provides regulatory certainty for device manufacturers, as the claimed discretion, if recognized by the Court, would have meant that any medical device potentially could be classified and regulated as a drug. In other words, FDA cannot regulate a device as a drug on a whim.

Manufacturing 40

Manufacturing Government Medical IT 40

FDA Law Blog

APRIL 21, 2024

Government—was that, despite having missed the statutory 60-day filing deadline, the patent was granted a PTE due to a change in the law created by Section 37 of the Leahy-Smith America Invents Act (“AIA”) ( Pub. . § The statute does not provide any applicable exception for such a falsity. But there may be more out there.

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Provider IT Government 59

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 52

Clinic Medical Provider Patients 52

FDA Law Blog

APRIL 30, 2021

Government Accountability Office report here ). As we perused the bills, we sorted them into three categories: the Good, the Bad, and the Ugly. Modernizing Therapeutic Equivalence Rating Determination Act (S. 1463 would make small, but very meaningful, changes to the statute to address and remedy current FDA inefficiencies.

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IT Clinic Government Provider 40

FDA Law Blog

APRIL 30, 2021

Government Accountability Office report here ). As we perused the bills, we sorted them into three categories: the Good, the Bad, and the Ugly. Modernizing Therapeutic Equivalence Rating Determination Act (S. 1463 would make small, but very meaningful, changes to the statute to address and remedy current FDA inefficiencies.

IT 40

IT Clinic Government Provider 40

GeriPal

JANUARY 11, 2024

The number of people who have used MAID in Canada since it was legalized in 2016 has increased year on year from about 1,000 people in the first year to over 13,000 people in 2022. Summary Transcript Summary Four percent of deaths in Canada are due to Medical Assistance in Dying (MAID). Four percent. AMA PRA Category 1 credit(s) ™.

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Illness IT Medical Provider 144

FDA Law Blog

FEBRUARY 11, 2024

The three letters together provide the range of actions DEA may take: no rescheduling from schedule I (former drug officials), rescheduling to schedule III (Democratic state attorneys general), or descheduling altogether (Democratic senators). Letter 1 is signed by former DEA administrators and Directors of National Drug Policy.

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Medical Healthcare Professional Community IT 59

GeriPal

APRIL 20, 2023

In what moral universe is a federal government deeply subsidizing my housing and not subsidizing that of my patients? I say with sarcasm, but that the government decided to subsidize home ownership and simultaneously designed a system where Black folks couldn’t be homeowners. We know what their income is. Margot: Yeah.

Mental Health 123

Mental Health IT Community Individual 123

GeriPal

DECEMBER 21, 2023

Don’t get me wrong, the evidence points to cost savings, but as Chris Callahan and Kathleen Unroe pointed out in a JAGS editorial in 2020 “in comprehensive dementia care models, savings may accrue to Medicare, but the expenses accrue to a fluid and unstable network of local service providers, patients, and their families.” 2015, 2016.

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FDA Law Blog

SEPTEMBER 14, 2021

This bill, which addresses numerous areas of the economy, public health, and government regulation, includes Subtitle E, Drug Pricing. A manufacturer that failed to provide access to the MFP would be subject to a civil monetary penalty of ten times the excessive price charged. Subtitle E is a slightly modified version of H.R.

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Manufacturing Insurance Government Patients 52

FDA Law Blog

JUNE 1, 2025

Government Accountability Office (GAO) published a report finding that, for the years 2016-2018, the pharmaceutical industry spent on average for a sample of 553 drug products approximately $6 billion annually on DTC advertisements, with a significant portion of this spending allocated to television commercials. In 2021, the U.S.

Healthcare Professional 59

Healthcare Professional Manufacturing Healthcare Utilities 59

Physicians News Digest

APRIL 3, 2025

Survey data gathered by AHRQ provides much of what is known about hospitalizations for motor accidents, measles, methamphetamine, and thousands of other medical issues. Makary published a controversial study in 2016 hypothesizing that errors killed 250,000 people a year in the U.S. Nobody does these things except AHRQ,” she said.

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FDA Law Blog

SEPTEMBER 13, 2021

Currently, individual Medicare Part D plan sponsors negotiate rebates but the government is explicitly prohibited from interfering in those negotiations. The attraction of the repeal is that Part D negotiations can potentially save the federal government “hundreds of billions of dollars,” as explained in the Plan.

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