Policy & Medicine10d
HHS OIG Reviews FDA’s Accelerated Approval of Aducanumab
Earlier this year, the United States Department of Health and Human Services Office of the Inspector General (HHS OIG) ...
JD Supra9d
FDA’s Recent Guidance on Accelerated Approval and Implications for Rare Diseases
In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed ...
JD Supra21d
OIG Deems Free Drug Patient Assistance Program Low-Risk in Advisory Opinion 25-01
The OIG concluded that the free Drug program implicated the AKS because the manufacturer provided remuneration to federal healthcare program beneficiaries, which could induce them to continue ...
The American Journal of Managed Care17d
Price Caps During Accelerated Approval Would Help Address Financial Toxicity for Patients, Jensen Says
The HHS OIG report calls for improved FDA oversight of the accelerated approval pathway, focusing on timely confirmatory trials and financial impacts on Medicare and Medicaid. Chelsee Jensen ...
The Scientist1y
FDA stinks at policing conflicts
Just when you thought nobody could be worse than the National Institutes of Health at managing financial conflicts of interest among trial investigators... The Inspector General of the Department of ...