FDA Law

APRIL 2, 2025

In that pre- Loper Bright case, FDA successfully defended its 2016 GRAS final rule. The Government argues that the FDCA is silent on whether the manufacturer must notify FDA of GRAS conclusions. [A]s you never got around to reading Center for Food Safety v. Becerra , now would be a good time to catch up.

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FDA Law

OCTOBER 13, 2024

A very important aspect of the program is that it costs FDA, and the government, no additional dollars, though we do not wish to minimize the additional resources a priority review demands over the standard review that such an application might otherwise receive. Notably, it was reauthorized in 2016 (until 2020) and in 2020 (until 2024).

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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. 53,688 (Aug. 53,767 (Aug.

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PEMBlog

JUNE 14, 2023

Government. Children’s Mental Health Emergency Department Visits: 2007-2016. Department of Health and Human Services (HHS) as part of an award (U07MC37471) totaling $3M with 0 percent financed with nongovernmental sources. Pediatrics. 2021;147(5):e2020030692. doi: 10.1542/peds.2020-030692 Pediatrics. 2020 Jun;145(6):e20191536.

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Mental Health Management Patient-Centered Illness 98

FDA Law

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In May 2016, FDA released a draft guidance document titled “Technical Considerations for Additive Manufactured Devices” (see our blog post on the draft guidance here ), which was finalized in 2018 (see our blog post on the final guidance here ).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

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FDA Law

JANUARY 15, 2024

Koblitz — You know a court decision is going to be worth reading when the judges compare FDA’s regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting. By David B. Clissold & Sara W.

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Manufacturing IT Provider ER 115

FDA Law

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This Draft Guidance, when finalized, will replace the Final Guidance issued just six years ago (the 2016 Guidance).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. Livornese — FDA recently published a Draft Guidance entitled “Charging for Investigational Drugs under an Investigational New Drug Application: Questions and Answers” (the Draft Guidance).

Clinic 52

Clinic Manufacturing Patients IT 52

FDA Law

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 ). products intended for medical purposes).

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Medical Manufacturing Healthcare Government 75

FDA Law

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. The memorandum also introduced the Program’s spanking new logo. The memorandum outlines CMS’s priorities and timeline for the Initial Price Applicability Year 2026.

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Manufacturing IT Provider Government 59

FDA Law

APRIL 19, 2021

After an FDA inspection in 2016, Genus was told that it could not distribute barium sulfate because it was an unapproved drug. The judges also said that changes to the language of the governing Federal Food, Drug, and Cosmetic Act over the last couple of decades did not abrogate the clear statutory definitions.

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FDA Law

APRIL 20, 2022

2016) to explain the circuit split, as the D.C. Given that FDA likely wants to preserve its existing interpretation of the scope of orphan drug exclusivity, we’d expect that a Government Petition would be firmly in favor of Certiorari. Jacobus also cites to Spectrum Pharms., Burwell , 824 F.3d 3d 1062 (D.C.

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IT Patients Government 52

FDA Law

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. After all, as we posted in 2016 , there have been approval date resets under certain circumstances.

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Provider IT Government 59

FDA Law

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.

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Clinic Medical Provider Patients 52

FDA Law

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. a) and 21 CFR 10.30).”

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FDA Law

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. a) and 21 CFR 10.30).”

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IT Clinic Government Provider 40

FDA Law

FEBRUARY 9, 2022

10, 2016); East Main Street Pharmacy; Affirmance of Suspension Order, 75 Fed. The Government alleged that Gulf Med regularly filled prescriptions for patients who traveled “an unusual distance” to obtain their prescriptions. Holiday CVS, 77 Fed. at 62,341; see Jones Total Healthcare Pharmacy, L.L.C. and SND Health Care, L.L.C.;

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FDA Law

JUNE 9, 2025

Since 1993, Congress has continued to direct the federal government, and in particular FDA, to take steps to close the gap in clinical research representation. Advancing the frontier of scientific knowledge has been an important rationale for diversifying trials. FDORA further directed FDA to issue guidance on the format and content of DAPs.

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Clinic IT Healthcare Medical 59

FDA Law

JUNE 12, 2022

Back in 2016, the First Circuit’s decision in United States ex rel. 2016) , was seen as a death knell for the fraud?on-the-FDA D’Agostino v. 3d 1 (1st Cir. on-the-FDA theory in FCA cases. and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.”

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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. In 2016 there were about a thousand MAID deaths, in 2021 there were about 10,000. Four percent. Eric: Yeah. Eric: Please.

Illness 144

Illness IT Medical Provider 144

FDA Law

FEBRUARY 11, 2024

There has been no evidence that marijuana’s schedule should change since the last rescheduling review in 2016. The regulated cannabis marketplace brings in billions of dollars in revenue into state and federal governments, with predictions that cannabis sales will exceed $53 billion by 2027. In other words, no rescheduling.

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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 124

Mental Health IT Community Individual 124

GeriPal

DECEMBER 21, 2023

2015, 2016. And then 2016 after CMMI finished the evaluation, it looked good, nothing happened. Just to let you know, Eric, we have to give the credit to our federal government. Our alliance is governed by a steering committee and we go to them and say what are the areas? That’s what Malaz is going to talk about.

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Patient-Centered IT Family Families 126

FDA Law

SEPTEMBER 14, 2021

This bill, which addresses numerous areas of the economy, public health, and government regulation, includes Subtitle E, Drug Pricing. For drugs approved before July 1, 2015, the baseline quarter is 1Q 2016, and for drugs approved after that date, the baseline quarter is the third full quarter after launch. 3, the Elijah E.

Manufacturing 52

Manufacturing Insurance Government Patients 52

FDA Law

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.

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Healthcare Professional Manufacturing Healthcare Utilities 59

FDA Law

MAY 19, 2022

CMS argued that the harm PhRMA members allege cannot be traced to this rule, but rather to CMS’s 2007 and 2016 rules that included an obligation to account for accumulator programs in BP calculations. It is uncertain whether the government will appeal the District Court’s decision.

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Physicians News Digest

APRIL 3, 2025

At their first meeting with the leadership of AHRQ last month, officials from Trump’s Department of Government Efficiency said that they didn’t know what the agency did — and that its budget would be cut by 80% to 90%, according to two people with knowledge of the meeting who were granted anonymity because of fears of retribution.

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FDA Law

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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