The Clinical Problem Solvers

MAY 2, 2022

Dr. Valtis is a 4th year Med-Peds Resident at Brigham & Women’s Hospital and Boston Children’s Hospital, and his research focuses on race and the utilization of security responses in the inpatient hospital setting. Race and the Utilization of Security Responses in a Hospital Setting. link] November 17, 2020. Orlando, FL.

Healthcare 52

Healthcare Utilities Hospital Internal Medicine 52

FDA Law Blog

JUNE 7, 2021

As an aside, we have found this inconsistency between which accelerated approval therapies are saddled with this sentence to be a paradoxical FDA policy as there is but a single standard for surrogate endpoints to be utilized for purposes of every Accelerated Approval (i.e., be “reasonably likely to predict” ultimate clinical benefit).

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Clinic IT Private Practice Utilities 98

BMJ

MAY 10, 2022

Introductory article to İkİIşik H, Sezerol MA, Taşçı Y, et alCOVID-19 vaccine hesitancy and related factors among primary healthcare workers in a district of Istanbul: a cross-sectional study from TurkeyFamily Medicine and Community Health 2022;10:e001430. 29% (n=86) of the participants were undecided about getting vaccinated.

Vaccination 40

Vaccination Healthcare Professional Healthcare Primary Care 40

FDA Law Blog

JUNE 2, 2023

For 10 high-cost single source covered outpatient drugs selected annually by CMS, manufacturers would be required to respond to a so-called “price verification survey” by providing not only clinical and utilization information about the drug, but also costs of production, distribution, research, and marketing; revenue and profit; and ex-U.S.

Manufacturing 59

Manufacturing Vaccination Government Diagnosis 59

FDA Law Blog

AUGUST 21, 2023

Further, FDA has utilized a variety of strategies to call attention to safety issues through Dear Doctor letters or other forms of communication, even if directing changes to labeling is difficult. Liability is precisely why the vaccine market shrunk so significantly in the 1980s, going from 26 manufacturers to 4, after lawsuits claiming $3.5

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Manufacturing Consulting Healthcare Professional Vaccination 40

FDA Law Blog

AUGUST 14, 2022

Vaccines: Starting in 2023, Medicare Part D will cover all adult vaccines approved by the Advisory Committee on Immunization Practices (“ACIP”) without any deductible or coinsurance. In return for providing the MFP, manufacturers of selected drugs do receive coverage, but high utilization drugs are certain to have coverage anyway.

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Manufacturing Government Vaccination Utilities 98

FDA Law Blog

SEPTEMBER 14, 2021

The Part B rebate would exclude vaccines as well. 30, 2020, the Trump HHS published a final rule amending the safe harbors under the Federal health care program antikickback statute as they apply to manufacturer rebates paid to Medicare Part D plans, Medicaid Managed Care plans, and their PBMs.

Manufacturing 52

Manufacturing Insurance Government Patients 52