News & Analysis as of

Healthcare Pharmaceutical Industry Rulemaking Process

Polsinelli

Challenges to LDT Final Rule Continue as Rule Goes into Effect

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As discussed in our May 6, 2024, Client Alert, earlier this year FDA issued its Final Rule for the regulation of laboratory-developed tests (LDTs) that the FDA has historically treated with enforcement discretion. A week...more

McDermott Will & Emery

Trending in Telehealth: June 11 – 17, 2024

McDermott Will & Emery on

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

McDermott Will & Emery

Trending in Telehealth: May 21 – May 27, 2024

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

McDermott Will & Emery

Trending in Telehealth: May 14 – May 20, 2024

McDermott Will & Emery on

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

Quarles & Brady LLP

Kentucky Refiles Controversial Non-Resident Pharmacist License Regulation

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On April 15, 2024, the Kentucky Board of Pharmacy (“Board”) posted a suite of proposed non-resident pharmacist rules that will require any pharmacist working in another state and who provides services on a Kentucky citizen’s...more

McDermott Will & Emery

Trending in Telehealth: February 12 – February 26, 2024

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

Polsinelli

FDA 2023-24: A Look Back & A Peek Forward

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Most years are eventful for businesses regulated by the US Food and Drug Administration (“FDA”), and 2023 was no exception. 2024 promises more of the same – it being a Presidential election year, some FDA decisions (increased...more

McDermott Will & Emery

Trending in Telehealth: January 4 – 15, 2024

McDermott Will & Emery on

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

Ballard Spahr LLP

HHS Announces Temporary Copay Accumulator Non-Enforcement Policy

Ballard Spahr LLP on

The United States Department of Health and Human Services (HHS) has filed court pleadings stating that it does not intend to initiate enforcement actions against plans that maintain copay accumulator programs....more

McDermott Will & Emery

Trending in Telehealth: July 11 – 17, 2023

McDermott Will & Emery on

Trending in Telehealth is a new series from the McDermott digital health team in which we highlight state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies,...more

BakerHostetler

OMB Reviewing HRSA Proposed Rule For Civil Monetary Penalties And Ceiling Price Regulations For 340B Drug Discount Program

BakerHostetler on

The agency that oversees the 340B Drug Discount Program (340B program) is seeking review by the White House Office of Management and Budget (OMB) of a proposed rule that would use civil monetary penalties to enforce ceiling...more

Akerman LLP - Health Law Rx

Florida Board Of Pharmacy Clarifies That Pharmacies Can't Compound Sterile Human Drugs For "Office Use"

The Florida Board of Pharmacy rules allow pharmacies to engage in office-use compounding. Rule 64B16-27.700, FAC. This allows pharmacies to compound drugs for physicians to use in treating their patients in the office without...more

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