News & Analysis as of

Interim Guidance Healthcare

Quarles & Brady LLP

FDA Releases Draft Interim Guidance on Bulk Drug Substances in Compounding Under Sections 503A and 503B of FDCA

Quarles & Brady LLP on

The Food and Drug Administration (“FDA”) has released draft interim guidance documents that impact the use of bulk drug substances in compounding under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act...more

Constangy, Brooks, Smith & Prophete, LLP

No COVID-19 ETS Yet, But A National Emphasis Program And updated Enforcement Guidance

The Occupational Safety and Health Administration did not issue an Emergency Temporary Standard on COVID-19 yesterday as had been widely anticipated. Instead, on Friday, OSHA issued both a Compliance Directive establishing a...more

Mintz - Health Care Viewpoints

CMS Provides Guidance to States on Managed Care Contract Review

As states attempt to control increasing healthcare costs, many Medicaid programs are seeking approval from the Centers for Medicare & Medicaid Services (CMS) to implement Medicaid managed care programs. In 2013, nearly 68...more

Foley & Lardner LLP

Waiting on Sequenom

Foley & Lardner LLP on

As I write this there’s a voice in my head saying, “Be careful what you wish for!” but it has been five months since Sequenom was argued at the Federal Circuit, and the court has yet to issue its decision. In the meantime,...more

BakerHostetler

IRS Interim Guidance Creates New Category of Permissible Arrangements - Public Comments Due January 22, 2015

BakerHostetler on

On October 24, 2014, the IRS issued Announcement 2014-67, which “amplifies” Rev. Proc. 97-13 regarding certain management contracts that do not result in private business use. Prior to this Announcement, Rev. Proc. 97-13...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Can Digital Healthcare Innovation Be Patented? Eligibility of Digital Healthcare Technologies Under the New USPTO Eligibility...

Digital healthcare, the confluence of digital technology with medical and other biological fields, has become an ever-increasing presence in our daily lives. Ideas that seemed nearly impossible just a few years ago (such as...more

BakerHostetler

IRS Interim Guidance Creates New Category of Permissible Arrangements

BakerHostetler on

On October 24, 2014, the IRS issued Announcement 2014-67, which “amplifies” Rev. Proc. 97-13 regarding certain management contracts that do not result in private business use. Prior to this Announcement, Rev. Proc. 97-13...more

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