Policy Prescription

JANUARY 31, 2022

state boards of pharmacy to properly regulate pharmacies that irresponsibly and too often illegally profited from opioid drug sales to patients. From the Commonwealth Fund : “West Virginia had not only the highest state rate of “deaths of despair” in 2016 but the biggest increase in deaths from these causes since 2005.”.

Pharmacy 52

Pharmacy Regulations Doctors Drugs 52

Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Science Regulations Production 40

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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Therapies Virus DNA Clinical Trials 135

Agency IQ

DECEMBER 11, 2023

Previously, burdensome side effects may have been written off as a necessary part of treatment and benefits measured in additional weeks or months of survival time; today, though, patients, clinicians, and regulators expect more. At the same time, big data presents exciting opportunities. For example, improved methods in data collection (e.g.,

FDA 40

FDA Science Clinical Trials Trials 40

Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Science Regulations Production 40

Agency IQ

JUNE 17, 2024

As reported by POLITICO , “The decision — if allowed by the Supreme Court to take effect — would roll back actions the federal government has taken since 2016 to make the pills more accessible, including rules allowing online ordering, mail delivery, and pharmacy dispensing of the drugs. They were not purchasing mifepristone.

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FDA Doctors Testimonials Regulations 40

Agency IQ

AUGUST 2, 2024

The Office of the National Coordinator for Health Information Technology, which has been historically known as ONC, is the federal entity that oversees many of the health information technology (IT) products that are carved out of FDA’s authority under the provisions of the 2016 21 st Century Cures Act.

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FDA Laboratories Pharmacy Government 40

FDA Law Blog: Biosimilars

JUNE 23, 2024

The CSA and regulations promulgated by DEA are intended to reduce the potential for diversion and abuse and ensure that controlled substances are dispensed and delivered to patients for a legitimate medical purpose. In either event, the 2016 DEA guidance letter is not currently published or otherwise available on DEA’s guidance portal. [4]

Nurses 98

Nurses Therapies Regulations Pharmacy 98

Drug & Device Law

JANUARY 4, 2024

115, 125 (2016). Alabama State Board of Pharmacy , 61 F.4th Okuley’s Pharmacy & Home Medical , N.E.3d 341 (2001), and the exclusivity Buckman recognized of FDA authority over approval of the products it regulates also provide grounds for implied conflict preemption those the Complaint’s allegations. Puerto Rico v.

Vaccine 59

Vaccine FDA FDA Approval Production 59

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.

Testimonials 105

Testimonials Drugs FDA Vaccine 105

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. . . Defendants’ “argument that no medical practitioner or pharmacy in the state of West Virginia would ever prescribe or sell mifepristone [was] facially implausible.” Sorsaia , 2023 WL 3211847, at *2.

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FDA Approval Pharmacy FDA Production 111