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15 Dec 2011, 8:41 am by PritzkerLaw
To ensure that our food is safe, the FDA, an agency within HHS, must conduct inspections of food facilities nationwide. [read post]
10 Feb 2012, 6:34 am by david
A check on regulations.gov shows more than 80,000 public comments were submitted concerning the HHS regulation. [read post]
On June 1, 2016, Senators responded to the proposed rule by writing a letter to the Secretary of HHS, urging HHS to increase this patient cap to 500 patients in its final rulemaking. [read post]
8 Aug 2014, 5:40 am by Cynthia Marcotte Stamer
  HHS says insurers and TPAs have work to complete by 9/27 to prepare to comply with the EDGE system data reporting that HHS will require them to conduct as part of ACA’s reinsurance premium and risk adjustment risk sharing provisions. [read post]
1 Nov 2007, 11:45 am
HHS OIG Memorandum Report: Laboratory Preparedness for Pandemic Influenza, October 24, 2007 (OEI-04-07-00670), 10 pages, PDF. [read post]
The rule is broad in scope, affecting the “various civil monetary penalty authorities for all agencies within HHS. [read post]
24 May 2019, 7:05 am by lbergeson@lawbc.com
Food and Drug Administration’s (FDA) Department of Health and Human Services (HHS) announced via the Federal Register the availability of a draft guidance for industry titled “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations. [read post]
19 Sep 2019, 4:15 am by IPWatchdog
In response to this, the Pass USMCA Coalition is touting a memo penned by Former Department of Health and Human Services (HHS) Secretary Tommy Thompson aimed at “debunking the widespread myth that the USMCA will drive up drug prices. [read post]
30 Nov 2020, 10:00 pm
In an apparent effort to combat prescription drug shortages and price spikes, the US Department of Health and Human Services (HHS) recently announced the forthcoming termination of FDA’s Unapproved Drugs Initiative (UDI). [read post]
4 Feb 2016, 10:00 pm
Department of Health and Human Services (HHS) Substance Abuse and Mental Health Services Administration released a proposed rule amending the confidentiality of substance use disorder patient records at 42 C.F.R. [read post]
29 Apr 2024, 12:45 pm by Bradley Merrill Thompson
Turns out, ignorance really is bliss, at least according to the Office of Civil Rights (“OCR”) within the Department of Health and Human Services (“HHS”), in publishing its final rule on algorithmic discrimination by payers and providers. [read post]
30 Nov 2020, 10:00 pm
In an apparent effort to combat prescription drug shortages and price spikes, the US Department of Health and Human Services (HHS) recently announced the forthcoming termination of FDA’s Unapproved Drugs Initiative (UDI). [read post]
30 Nov 2020, 10:00 pm
In an apparent effort to combat prescription drug shortages and price spikes, the US Department of Health and Human Services (HHS) recently announced the forthcoming termination of FDA’s Unapproved Drugs Initiative (UDI). [read post]
30 Nov 2020, 10:00 pm
In an apparent effort to combat prescription drug shortages and price spikes, the US Department of Health and Human Services (HHS) recently announced the forthcoming termination of FDA’s Unapproved Drugs Initiative (UDI). [read post]
9 Dec 2010, 9:59 pm by Patent Docs
By James DeGiulio -- On August 2, patients with the rare Fabry disease petitioned the Department of Health and Human Services to exercise the "march-in" powers under the federal Bayh-Dole Act, and issue an open license to use patents needed to manufacture Genzyme's enzyme replacement drug Fabrazyme (see "Genzyme's Manufacturing Issues with Fabrazyme Prompt Patients to Petition HHS Secretary to Exercise Bayh-Dole "March-in" Rights"). [read post]
30 May 2018, 7:13 am by Lindsay Offutt
King County sued the US Department of Health & Human Services (HHS) [official website] when it ended funding the $5 million grant through the Teen Pregnancy Prevention Program (TPP Program) [materials] for sexual education. [read post]
4 Feb 2016, 10:00 pm
Department of Health and Human Services (HHS) Substance Abuse and Mental Health Services Administration released a proposed rule amending the confidentiality of substance use disorder patient records at 42 C.F.R. [read post]
30 Nov 2020, 10:00 pm
In an apparent effort to combat prescription drug shortages and price spikes, the US Department of Health and Human Services (HHS) recently announced the forthcoming termination of FDA’s Unapproved Drugs Initiative (UDI). [read post]
30 Nov 2020, 10:00 pm
In an apparent effort to combat prescription drug shortages and price spikes, the US Department of Health and Human Services (HHS) recently announced the forthcoming termination of FDA’s Unapproved Drugs Initiative (UDI). [read post]