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Pharmaceutical Industry › Statutory Authority

Troutman Pepper Locke

12 Days of Regulatory Insights: Day 3 - State AG Oversight in the Health Care Industry — Regulatory Oversight Podcast

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In the third episode of our special 12 Days of Regulatory Insights podcast series, Chris Carlson is joined by Barry Boise, a seasoned partner in Troutman Pepper’s Health Sciences Litigation practice group, to explore the...more

Troutman Pepper Locke

Kentucky AG Checks the Board of Pharmacy’s Regulatory Power

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On November 12, the Kentucky attorney general (AG) issued a formal opinion, concluding that the Kentucky Board of Pharmacy lacks the authority to regulate nonresident pharmacists beyond what is specified in KRS Chapter 315....more

Quarles & Brady LLP

Kentucky Attorney General Determines Board of Pharmacy Lacks Statutory Authority to Regulate Non-Resident Pharmacists

Quarles & Brady LLP on

The Kentucky Attorney General published a formal opinion yesterday confirming that the Board of Pharmacy cannot require the licensure of pharmacists who reside outside of the Commonwealth of Kentucky. The proposed...more

Axinn, Veltrop & Harkrider LLP

One Too Many Suits Against FDA?

Axinn, Veltrop & Harkrider LLP on

Before filing a lawsuit against FDA, I often get asked by clients whether FDA will retaliate by, for example, delaying review times or more closely scrutinizing applications. My response to this question is always the same –...more

K&L Gates LLP

340B Update: Appellate Court Upholds 340B Payment Reduction as CMS Proposes Further Reductions for 2021

K&L Gates LLP on

In this week’s episode, Darlene Davis, Andrew Ruskin, and Gabriel Scott discuss notable recent developments for reimbursement under the Hospital Outpatient Prospective Payment System (“OPPS”) of drugs purchased under the 340B...more

Mintz - Health Care Viewpoints

Federal Judge Strikes Down HHS Drug Pricing Disclosure Rule

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In follow-up to our previous post, the pharmaceutical industry gained a win on July 8th when a federal judge struck down the Trump administration’s rule that would have required drugmakers to include list prices for drugs in...more

Troutman Pepper Locke

HHS to Require Manufacturers to Disclose Drug Pricing in Television Advertisements

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U.S. health officials have taken the first concrete step toward implementing the vision set out in the “American Patients First” blueprint published by President Trump and Health and Human Services (HHS) Secretary Alex Azar...more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Precedential Patent Cases From the Federal Circuit

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In Mylan v. Aurobindo the Circuit affirms the grant of a preliminary injunction based upon the infringement of one of the three patents in suit. However, the panel reverses the injunction as to the other two patents based on...more

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