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Pharmaceutical Industry › Registration Requirement › Prescription Drugs

Barnea Jaffa Lande & Co.

Drug registration reform in Israel: processes are being streamlined and timeframes shortened to increase supply and lower prices

Barnea Jaffa Lande & Co. on

We are living in an era of revolutionary medical innovation, particularly in the research and development of medicinal products. Diseases that were once considered incurable, are now treated with drugs, vaccines and...more

DLA Piper

DEA and HHS Propose Telemedicine Special Registration and Finalize Buprenorphine Telemedicine Prescribing Rules

DLA Piper on

On January 17, 2025, the US Drug Enforcement Administration (DEA) and the US Department of Health and Human Services (HHS) published two rules regarding telemedicine prescribing of controlled substances: a proposed rule...more

Robinson+Cole Health Law Diagnosis

HRSA Confirms End of COVID Waiver of Advance Registration Requirement for Provider-Based Clinics

Robinson+Cole Health Law Diagnosis on

On September 27, 2023, the Health Resources and Services Administration (HRSA) issued a Notice in the Federal Register applicable to all 340B Program hospitals that formally ends a COVID-era waiver of the long-standing HRSA...more

McDermott Will & Schulte

HRSA Issues Notice Confirming 340B Registration Requirement

McDermott Will & Schulte on

On October 26, the Health Resources and Services Administration (HRSA) published a Federal Register notice addressing the use of 340B drugs at off-campus hospital outpatient locations that have not yet appeared on a filed...more

Quarles & Brady LLP

Kentucky Board of Pharmacy Regulation Committee Proposes New Requirement of Licensure for All Out-of-State Pharmacists

Quarles & Brady LLP on

On March 15, 2022, the Regulation Committee for the Kentucky Board of Pharmacy reviewed potential amendments and proposed regulations governing non-resident pharmacy licensure in the state. Among the proposed changes is a...more

Polsinelli

Pharmacy Benefit Managers Licensing and Compliance Developments

Polsinelli on

In response to calls for greater transparency in the prescription drug industry, 2021 continued a nationwide trend of increased state licensing and regulation of Pharmacy Benefit Managers (“PBMs”). In the last year, laws...more

Quarles & Brady LLP

Nevada to Require Out-of-State Pharmacists that Dispense or Compound for Nevada Patients to Hold a Nevada Pharmacist’s License

Quarles & Brady LLP on

If you are a Nevada licensed non-resident pharmacy, you will soon be receiving notification from the Nevada Board of Pharmacy (“Board”) stating that any pharmacist who dispenses or compounds prescriptions for a controlled...more

Polsinelli

Third Party Administrator (TPA) Licensing and Compliance Developments - January 2020

Polsinelli on

In response to calls for greater transparency in the prescription drug industry, 2019 continued a nationwide trend of increased state licensing and regulation of pharmacy benefit managers (“PBMs”). In the last year, laws...more

Hogan Lovells

CMS proposes requiring drug prices in TV ads

Hogan Lovells on

On October 15, CMS released a proposed rule titled “Medicare and Medicaid Programs: Drug Pricing Transparency,” which would require direct-to-consumer (DTC) advertisements for prescription drugs covered by Medicare or...more

Saul Ewing LLP

New Jersey Rulings Allay Personal Jurisdiction Concerns Raised by Daimler and Goodyear

Saul Ewing LLP on

Two judges in the U.S. District Court for the District of New Jersey have denied motions to dismiss for personal jurisdiction in Hatch-Waxman litigations based on the defendants’ compliance with New Jersey’s foreign...more

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