Mondaq USA: Food, Drugs, Healthcare, Life Sciences
Jones Day
People interested in participating are invited to register using the form available on the website.
Jones Day
The GVP guidance was effective on August 16, 2016.
BakerHostetler
Sundae Williams, the owner of Serenity Marketing Inc., made unsolicited phone calls to recruit patients, including Medicare beneficiaries, for contracted home health agencies.
BakerHostetler
Now that the kids are back in school and summer vacations are in the rearview mirror, it's time to catch up on recent fraud and abuse developments.
BakerHostetler
The CMS recently released a proposed rule addressing the treatment of third-party payments when calculating uncompensated care costs for the Medicaid disproportionate share hospital formula.
Jones Day
The meeting will be available via webcast, but there will not be a transcript available following the meeting.
Jones Day
With this proposal, FDA intends to help ensure adequate protection of animal research subjects and the quality and integrity of data submitted to FDA.
Reed Smith
We've blogged several times over the past couple years about the 2015 amendments to the federal rules as they pertain to discovery, including electronic discovery.
Jones Day
A GLP Quality System will provide the appropriate framework for building quality into a nonclinical laboratory study and will result in more reliable data for FDA to consider when making regulatory decisions.
Jones Day
In the August 8, 2016, Federal Register, FDA announced it is reopening the comment period for the potential development of a user-fee program for nonprescription, or OTC, monograph drugs.
Khurana and Khurana
The COMBAT Act would amend Section 505(c)(3)(E) of the Federal Food, Drug, and Cosmetic Act i.e. 21 U.S.C. 355(c)(3)(E).
Foley & Lardner
But zero dollars were awarded to Florida, and this was not the first time Floridians missed out on telemedicine grants.
Jones Day
The fee rates are effective October 1, 2016, and will remain in effect through September 30, 2017.
Reed Smith
Here we go. Again. The third bellwether trial in the Pinnacle Hip Implant MDL starts on October 3 (less than two weeks away), and the parties began picking a jury two days ago.
Reed Smith
On September 21, 2016, the House Ways and Means Committee approved H.R. 5713, the "Sustaining Healthcare Integrity and Fair Treatment Act of 2016" or "SHIFT Act."
Jones Day
Last month, FDA announced the beginning of its intercenter consult request process that will be piloted across the Agency through 2017.
Reed Smith
The OIG has released its Medicaid Fraud Control Units Fiscal Year 2015 Annual Report, which compiles data on investigations and prosecutions by the 50 MFCUs.
Jones Day
At the end of July 2016, FDA announced the availability of a draft guidance titled "Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)."
Jones Day
For example, the checklist includes recommendations for written procedures regarding IRB membership and managing conflicts of interest of IRB members.
Jones Day
The foreseen activities for this new work stream are outlined in the annex to the roadmap and will start in fall/autumn 2016.
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Foley & Lardner
The Arkansas Legislative Council's Rules and Regulations Subcommittee approved, on August 16, 2016, proposed regulations which will remove some restrictions on telemedicine providers...
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
The Massachusetts Department of Public Health (DPH) Determination of Need (DoN) Program has unveiled proposed regulations that constitute an ambitious and long overdue overhaul of the DoN Program regulations.
Proskauer Rose LLP
The new penalties became effective on August 1, 2016 and apply to any assessments after August 1, 2016 where the associated violation occurred after November 2, 2015.
Foley & Lardner
Price increases threatening the availability of EpiPen® and EpiPen Jr® Auto-Injectors ("EpiPen") have touched off the latest firestorm over drug pricing.
Morrison & Foerster LLP
On August 12, 2016, Southern District of California Judge William Q. Hayes denied most of a motion to dismiss and motion to strike in Hunter v. Nature's Way Products, LLC, Case No. 16cv532-WQH-BLM.
Reed Smith
CMS is soliciting public input on the "evolution" of its State Innovation Models Initiative, which was launched in 2013 to accelerate state design and testing of multi-payer payment and delivery models.
Brown Smith Wallace
Given the complexity of the Affordable Care Act (ACA), it should come as no surprise that many employers occasionally stumble in their compliance efforts. The
Jones Day
Data breach notification requirements in Arizona, Nebraska, and Tennessee took effect in July and August.
Reinhart Boerner Van Deuren S.C.
Plan administrators must distribute SARs to participants and beneficiaries within nine months of the plan's year end. For plan years that end December 31, the SAR is due September 30, 2016.
Littler Mendelson
The National Labor Relations Board recently addressed hospital employers' ability to prohibit picketing by off-duty employees on their own premises.
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