News & Analysis as of

Manufacturers Pharmaceutical Industry Federal Pilot Programs

Akin Gump Strauss Hauer & Feld LLP

What's New In Washington - September 2018

Following a truncated August recess, the House and the Senate returned to Washington after Labor Day with a full plate of legislative items to address prior to the end of the fiscal year on September 30. That list includes...more

Stinson LLP

FDA Draft Guidance and Pilot Program Seek to Expand Device Modifications Appropriate for the Special 510(k) Program

Stinson LLP on

In its continued effort to reduce time to market for regulated products and improve transparency, the Food and Drug Administration (FDA) published a draft guidance last Friday that, among other things, proposes to (i) expand...more

Akin Gump Strauss Hauer & Feld LLP

FDA Announces Quality Metrics Pilot Programs

• FDA has announced new quality metrics pilot programs that seek industry stakeholder perspective and feedback. • FDA’s voluntary pilot programs target companies submitting Type C and Pre-ANDA meeting requests, as well as...more

Mintz - Health Care Viewpoints

FDA 2017 Year in Review: Refining Medical Device Pathways and Introducing Pilot Programs to Promote Quality

This is the third installment of our year-in-review series covering major developments at FDA.  While the previous two installments, pertain to FDA actions on drugs and biologics, this post will address developments related...more

Baker Donelson

Real-Time EMR Interface Program to Reduce Readmissions Finds Favor in OIG Advisory Opinion 17-07

Baker Donelson on

A pilot program that could improve the efficacy of medication therapy management (MTM) services among Medicare Advantage (MA) beneficiaries would present minimal risk to federal health care programs and patients, according to...more

Robinson+Cole Health Law Diagnosis

OIG Advisory Opinion Allows Pilot Collaborative Program Proposed by Pharmaceutical Manufacturer for Medication Therapy Management...

On December 11, 2017, the Health and Human Services Office of Inspector General (OIG) posted a favorable Advisory Opinion, permitting a proposed pilot Program involving a collaboration between a pharmaceutical manufacturer...more

Hogan Lovells

FDA Makes Two Announcements on Electronic Tracking of Prescription Drugs to Comply with the Drug Supply Chain Security Act

Hogan Lovells on

On July 20, 2017, FDA published two announcements in the Federal Register related to the development of an electronic, interoperable system to identify and trace certain prescription drugs distributed within the United...more

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