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Food and Drug Administration (FDA) Healthcare PHRMA

Quarles & Brady LLP

FDA Approves Florida’s Section 804 Importation Program for Importation of Canadian Pharmaceuticals

Quarles & Brady LLP on

On January 5, 2024 the Food and Drug Administration (FDA) issued its approval of the State of Florida’s proposal to import certain prescription drugs from Canada under the Section 804 Importation Program (SIP). This approval...more

Epstein Becker & Green

Revisions to the PhRMA Code on Interactions with Health Care Professionals

Epstein Becker & Green on

On August 6, 2021, the Pharmaceutical Research and Manufacturers of America (“PhRMA”) released revisions to its Code on Interactions with Health Care Professionals (“Code”). The Code applies to pharmaceutical company...more

K&L Gates LLP

340B Orphan Drug Interpretive Rule Struck Down by D.C. District Court: HHS and HRSA Lose In Second Round of Litigation Over 340B...

K&L Gates LLP on

In an Opinion issued October 14, 2015, D.C. District Court Judge Rudolph Contreras granted Pharmaceutical Research and Manufacturers of America’s (“PhRMA”) motion for summary judgment against the U.S. Department of Health and...more

BakerHostetler

D.C. District Court Deals Blow to HHS 340B Program Interpretive Rule

BakerHostetler on

Court says Congress has the power to make the change that HHS attempted with its Interpretive Rule, and thus it should be left to the legislative branch. A lawsuit challenging the Interpretive Rule, filed by the...more

Mintz - Health Care Viewpoints

Health Care Update - July 2014 #3

In This Issue: - First Guidance following Hobby Lobby released - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional and State Initiatives ...more

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