FDA Law

OCTOBER 3, 2022

Mr. Bawduniak alleged that, between 2009 and 2014, Biogen paid illegal kickbacks to its largest prescribers to induce them to prescribe the company’s multiple sclerosis drugs, Avonex, Tysabri and Tecfidera, and discourage them from prescribing newer competitor products. This lawsuit was brought to the U.S. See United States ex rel.

Consulting 105

Consulting Healthcare Professional Specialization Government 105

FDA Law

MARCH 7, 2024

Sasinowski — In 2009 — 15 years ago — the National Organization for Rare Disorders (NORD) announced the first U.S. In 2009 I served as Chair of NORD and through the hard work of countless colleagues we inaugurated the first Rare Disease Day. By Frank J. recognition of Rare Disease Day.

Government 69

Government Community Specialization Education 69

FDA Law

OCTOBER 24, 2023

Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP). However, there’s a clear shift in FDA’s approach that is noticeable from the title of the Draft Guidance, alone.

Clinic 64

Clinic Clinical Practice Provider Utilities 64

FDA Law

MAY 3, 2021

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. Incomplete and inaccurate records currently subject registrants to civil monetary penalties of up to $15,691 per violation.

Management 52

Management Manufacturing Specialization IT 52

FDA Law

MAY 3, 2021

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. Incomplete and inaccurate records currently subject registrants to civil monetary penalties of up to $15,691 per violation.

Management 40

Management Manufacturing Specialization IT 40

GeriPal

MARCH 24, 2023

For others, this piece, while painful to read, gave voice to what they have been feeling over the last decade – hospice has in some ways lost its way in a quest of promoting profit over care. If you are interested in signing the position statement “Core Roles and Responsibilities of Physicians in Hospice Care”, click here. Is it you, Ira?

IT 112

IT Provider Patients Families 112

PEMBlog

MAY 24, 2023

Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. Government. 2009 Nov;27(4):655-67, ix. 2009 Jun;21(3):196-202. It is also episode 2 in a 5 episode series focused on agitation in children and adolescents. Coburn VA, Mycyk MB. Physical and chemical restraints.

Management 55

Management Patient-Centered Physicals Transportation 55