NIH Director's Blog: Drug Development

JANUARY 5, 2016

But before diving into our first “new science” post of 2016, let’s take a quick look back at 2015 and some of its remarkable accomplishments. Doctors prescribe opiates to control many kinds of pain , but opiates are also a source of great current societal concern, with a steadily increasing incidence of U.S.

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Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The FDA will follow these procedures for both agency-initiated operations (e.g.,

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FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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Codon

JANUARY 21, 2024

The European Medicines Agency (EMA) is similar in this regard, although interestingly, that’s not the case in the United Kingdom, where regulators are not so directly involved in assessing a challenge study beforehand. The challenge agent also has to be produced under very stringent protocols.

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Drug Discovery World

FEBRUARY 15, 2023

The number of new cases recorded between 2016 and 2018 was 375,400, with 167,142 deaths caused by cancer between 2017 and 2019. However, over the last few decades, it has been widely accepted that interaction between the tumour and host immune response plays a critical role in regulating tumour biology and hence its progression.

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Codon

FEBRUARY 13, 2024

Regulators traditionally want to see a single, stable, well-characterized drug before giving the green light for it to be tested in a clinical trial, not dozens of different viruses; let alone ones that are best found in unappealing places like sewage , hospital waste, or bird poop.

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Codon

JULY 21, 2024

A 2016 study found that rats who were tickled by their experimenters exhibited Freudensprünge, “joy jumps,” and emitted positive vocalizations. This is due, in part, to perceptions of public safety, and by extension, regulation. research universities, are responsible for the oversight and management of animal studies.

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Codon

JULY 27, 2023

There’s a TV show where a bunch of doctors are walking through a hospital corridor. These protein:RNA duos seem to regulate gene expression in a way that we don’t really understand. This minimal cell, first reported in 2016, was about half as fit as a normal M. All the colors had the same brightness. mycoides cell.

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Codon

JULY 27, 2023

There’s a TV show where a bunch of doctors are walking through a hospital corridor. These protein:RNA duos seem to regulate gene expression in a way that we don’t really understand. This minimal cell, first reported in 2016, was about half as fit as a normal M. All the colors had the same brightness. mycoides cell.

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The Pharma Data

JUNE 18, 2021

” The pivotal Phase 3 RESONATE-2 study served as the basis for the FDA approval of IMBRUVICA as a single-agent in first-line treatment for CLL/SLL in 2016, following initial approval for relapsed/refractory (R/R) patients in 2014 based on the RESONATE study. Call your doctor for medical advice about side effects.

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The Pharma Data

MAY 13, 2021

Description: How A Handsome Doctor From Texas Saved My Life. I could hear doctors and nurses speaking in hushed tones…. I gave up carbs, fats, alcohol, meat – just as the doctor ordered…. My dear old doctor told me that hormone testing is expensive and unnecessary…. My doctor said it was all simple math….

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FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

There has been no evidence that marijuana’s schedule should change since the last rescheduling review in 2016. A state-regulated cannabis industry better protects consumers than the illicit market or the unregulated intoxicating hemp-derived marketplace. In other words, no rescheduling. January 29, 2024).

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Drug & Device Law

MAY 19, 2023

In 2016 (during the Obama Administration), the FDA amended this REMS, “expanding those who could be certified to prescribe. . . None of the cases in which doctors, contraceptive providers, or other vendors were found by the Supreme Court to have standing found that relief was impermissibly premised on third-party customer sales.”

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Drug & Device Law

DECEMBER 29, 2023

Indeed, even the weird alternatives the plaintiff advocated, such as “point of sale” signs and DTC advertising (assuming these were Prop 65 remedies at all), were still FDA-regulated labeling. Alcozar didn’t buy it, since the particular regulations did not even apply to the clinics and health care providers that plaintiffs were targeting.

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Drug & Device Law

AUGUST 8, 2022

Apparently, a fraudulent foreign-trained “doctor” treated the plaintiffs, none of whom claimed malpractice or any physical injury whatsoever. Anyway, this fraudulent “doctor” allegedly “touched them without informed consent” and caused them “emotional distress. 2016) (association’s “adoption of rules, policies, and procedures. . .

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Drug & Device Law

OCTOBER 7, 2022

1938 (2016), but the lack of a presumption meant plaintiff’s claim was preempted. The purported misrepresentations to doctors “flow factually from her allegations of fraud-on-the-FDA,” so they were also preempted. Citing Buckman and CSX , the court correctly held that there is no presumption against express or implied preemption.

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Drug & Device Law

FEBRUARY 11, 2024

On appeal, the Fifth Circuit overturned the District Court’s nullification of the FDA’s approvals of both branded and generic versions of mifepristone but affirmed that court’s voiding of both the 2016 risk evaluation and mitigation strategy (“REMS”) and 2021 non-enforcement decision that allowed telemedicine prescription of mifepristone.

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Drug & Device Law

FEBRUARY 16, 2024

Based on the plain meaning of the regulation, Defendant could not alter the medication without submission to the FDA for ‘approval prior to distribution of the product made using the change.’ Consequently, to the extent Plaintiffs’ design defect claim is based on Cialis’s formulation, it is preempted. Allied Mut. 2d 262, 266 (9th Cir.

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Drug & Device Law

APRIL 20, 2023

This dive into the latest on reproductive rights in the context of challenges to FDA’s regulation of a prescription medication is an instance where we wish we had not been right with some of our predictions. We do not hold that doctors have constitutional standing whenever they’re called upon to do their jobs. That is unusual.

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Drug & Device Law

JUNE 28, 2022

In enacting the FDCA, Congress created the FDA and charged it with “promot[ing] the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner.” 1, 16-22 (2016) (collecting examples). 393(b)(2)(B). 363, 373 (2000)). Jones , 225 U.S.

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