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Regulatory Oversight Patient Access

DLA Piper

Keeping Watch on the Inflation Reduction Act: Medicare Poses Part D Formulary Access Challenges

DLA Piper on

Key points include access to medicines in medicare is reduced as the IRA is implemented; fewer drugs are covered on Medicare Part D formularies in 2025 relative to 2024; medicines for serious conditions with high unmet needs...more

Troutman Pepper Locke

Virginia Advances Toward New Medical Cannabis License Application With New Regulations

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The Virginia Cannabis Control Authority (CCA), which assumed oversight of Virginia’s medical cannabis program from the Board of Pharmacy as of January 1, has promulgated regulations to govern medical cannabis operations in...more

Seyfarth Shaw LLP

The Week in Weed: October 2023 # 2

Seyfarth Shaw LLP on

Welcome back to The Week in Weed, your Friday look at what’s happening in the world of legalized marijuana. This week, we see Georgia pharmacies selling medical marijuana. We have an update on the Ohio legalization ballot...more

Troutman Pepper Locke

Georgia to Become First State in the Nation to Allow Medical Marijuana in Pharmacies

Troutman Pepper Locke on

The Georgia Board of Pharmacy has begun accepting applications from independent, licensed pharmacies for authorization to dispense authorized medical marijuana products, and nearly 120 pharmacies reportedly have agreed to...more

Troutman Pepper Locke

Application for Last Available Medical Cannabis License in Virginia to Be Supervised by Virginia Cannabis Control Authority

Troutman Pepper Locke on

On October 2, the Virginia Board of Pharmacy posted a general notice indicating that it had voted to rescind the request for applications (RFA) for a Pharmaceutical Processor license in Health Service Area I. The RFA will now...more

Robinson+Cole Health Law Diagnosis

California Governor Signs Trailer Bill to State Budget Increasing Oversight of Health Care Entities Statewide

On June 30, 2022, Governor Gavin Newsom signed the 2022-2023 California state budget, which included a trailer bill, Senate Bill 184 (the Bill) which makes numerous statutory revisions impacting health programs and consumers....more

Jones Day

Tillis Urges FDA, USPTO to Investigate Potential False Narrative by Drug Critics

Jones Day on

On January 31, 2022, Sen. Thom Tillis (R-N.C.), the Ranking Member of the Senate Judiciary Committee Subcommittee on Intellectual Property, sent a letter to Janet Woodcock, Acting Commissioner of the FDA, and Drew...more

Kramer Levin Naftalis & Frankel LLP

NAIC Considers PBM Regulation; Additional Requirements Possibly on Tap

Pharmacy benefit managers (PBMs) should consider the implications of a model law making its way through the National Association of Insurance Commissioners (NAIC) that would establish a licensure requirement and rules of...more

Hogan Lovells

The European Commission proposes a new Pharmaceutical Strategy for the EU

Hogan Lovells on

On 25 November 2020, the European Commission published a proposal for a new Pharmaceutical Strategy for Europe (“the Strategy”). The Strategy is built around four main objectives, each with an assigned work strand....more

Verrill

Federal "Right to Try": Don't Disregard Your State Laws Just Yet!

Verrill on

How Federal Preemption (or Lack Thereof) Could Influence the Use of Federal "Right to Try" - As discussed in our Alert of June 4, "Right to Try" Comes to the Federal Stage: What Stakeholders Should Do Now, manufacturers,...more

Verrill

"Right to Try" Comes to the Federal Stage: What Stakeholders Should Do Now

Verrill on

On May 30, 2018, surrounded by patients directly impacted by tragic and intractable diseases, President Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017...more

Troutman Pepper Locke

Right to Try Legislation: Worthwhile or Window Dressing?

Troutman Pepper Locke on

"Right to Try" legislation, which enables terminally ill patients or patients with a "life threatening disease or condition" to seek access to investigative drugs with little to no oversight from the FDA, has been enacted in...more

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