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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Drug Discovery World

JUNE 20, 2024

billion 1 is the estimated cost of bringing a new drug from the drawing board to pharmacy shelves today. Moreover, the current landscape lacks comprehensive regulations specifically tailored to the use of AI in healthcare, leaving a gray area around the responsible deployment of LLMs. An oncology trial generates about 3.1

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The Pharma Data

MAY 13, 2021

WITHOUT doctors, physical therapists or chiropractors. Our Unique Solution Has Been Featured All Over The Media, From Hallmark, The Doctors, Atlanta Live & Arizona Midday…. I Have A Doctorate In Pharmacy, But Everything I Learned About Pain Relief In Pharmacy School Is Dead Wrong! And there’s more!

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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. Phage therapies are sold at a pharmacy in Georgia.

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Drug & Device Law

MAY 19, 2023

In 2023 (during the Biden Administration), “the FDA promulgated a new REMS for mifepristone which no longer limits dispensation of the drug to healthcare settings, thereby allowing patients to receive the medication either by mail or from certified pharmacies.” Sorsaia , 2023 WL 3211847, at *2. T]he growing market for mifepristone. . .

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Drug & Device Law

JULY 18, 2022

2370 (2022), vacated the convictions of a couple of alleged “pill mill” doctors under the Controlled Substances Act upon finding that the government’s proof in their criminal trial did not meet the standard required by 21 U.S.C. Section 331(ccc)(2), prohibiting “the intentional falsification of a prescription” for a pharmacy compounded drug.

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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

SEPTEMBER 14, 2023

One particularly long-standing and road-winding issue has been FDA’s authority to discourage, prevent, and discourage the promotion of off-label use of FDA-regulated medical products. As we have pointed out many times, FDA does not regulate the practice of medicine. at *29-30. We agree with that to a degree.

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Drug & Device Law

OCTOBER 26, 2023

Plaintiffs constantly seek to create FDCA violations that do not exist, often through bizarre interpretations of FDA regulations that the FDA has never followed. Applying regulations intended for manufacturers (or, here, compounders) instead to health care providers would have made a mockery of the FDA’s regulatory scheme.

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Drug & Device Law

MAY 26, 2023

We are not looking do either of those, but we will weigh in on what NPP means for non-product liability cases involving FDA-regulated medical products. A state cannot regulate commerce occurring wholly outside its borders. Charting which justices joined which opinions on which issues looks like a psilocybin-induced Venn diagram.

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