Mondaq USA: Food, Drugs, Healthcare, Life Sciences
Arnold & Porter Kaye Scholer LLP
Following the implementation of the new EudraVigilance system, reported in our previous post, and in an attempt to streamline the monitoring of safety signals in EudraVigilance, the EMA has recently announced that ...
Reed Smith
The Trump Administration has rolled out its first CMS Innovation Center Medicare bundled payment initiative, the Bundled Payments for Care Improvement Advanced (BPCI Advanced).
Reed Smith
CMS has announced a new initiative allowing states to propose demonstrations to "improve Medicaid enrollee health and well-being through incentivizing work and community engagement."
Lewis Roca Rothgerber Christie LLP
On December 29, 2017, the SB 16-197 Working Group released its report to the Senate Business, Labor, and Technology Committee and the House Business Affairs and Labor Committee...
Cadwalader, Wickersham & Taft LLP
In addition to imposing the fine, the Order requires the Bank's branches to submit periodic progress reports to their applicable Federal Reserve Banks detailing steps taken to comply with the conditions of the Order.
Ropes & Gray LLP
Unless HHS takes further regulatory action to delay the compliance date, research initiated on or after July 19, 2018 will be required to comply with the revised Common Rule.
Kramer Levin Naftalis & Frankel LLP
Liquid alternative mutual fund specialist Catalyst Funds and BNP Paribas partnered to form the BNP Paribas Catalyst Systematic Alpha Index, a risk premia strategy that allocates between seven strategies ...
Reed Smith
A number of recent Congressional hearings focused on the opioid crisis, including the following:
Day Pitney LLP
Beginning January 16, the amount of compensation that a New Jersey healthcare provider can accept from pharmaceutical manufacturers for "bona fide services," ...
Wilson Elser Moskowitz Edelman & Dicker LLP
Recent developments in three New England states indicate that popular support for legalized marijuana is growing, even as the federal government reverses the hands-off policy of the previous administration.
Holland & Knight
On Jan. 4, 2018, the HHS Office of Inspector General (OIG) issued an open letter containing guidance regarding the provision of certain free drugs to federal healthcare program beneficiaries.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
I previously said that the year 2014 may be a game-changer for the 340B Drug Discount Program. Increasing HRSA audits, a lawsuit over the 340B Orphan Drug Rule, and HRSA's promise to issue...
Seyfarth Shaw LLP
In a recent article, senior officials with the Department of Justice's Office of the United States Trustee (the "UST"), the federal government's watchdog of the bankruptcy system ...
Troutman Sanders LLP
A case currently pending before the U.S. Court of Appeals for the D.C. Circuit challenges the applicability of the federal Contraband Cigarette Trafficking Act ("CCTA") to tribal entities.
Troutman Sanders LLP
Pending before the Mississippi Legislature is House Bill 906, which, if enacted, would increase the "tobacco equity tax" applicable to cigarettes manufactured by non-signatories ...
Reed Smith
As previously reported, the 21st Century Cures Act prohibits FFP payments to the states for certain Medicaid DME expenditures that exceed what Medicare would have paid for such items...
BakerHostetler
House Republicans will gather tonight for a GOP-only meeting to plot strategy on passing a stopgap budget bill, but a breakdown among key senators on separate immigration legislation ...
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Congress has four days to fund the government. The emerging spending deal could include any number of legislative priorities.
Archer & Greiner P.C.
The U.S. Department of Justice decision to rescind Obama-era guidance on marijuana enforcement elicited furious statements from lawmakers on both sides of the aisle.
Morrison & Foerster LLP
In December, the U.S. Food and Drug Administration (FDA) issued guidance on Technical Considerations for Additive Manufactured Medical Devices.
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Morgan Lewis
Amgen paints a different picture as to the bad actor during the parties' negotiations pursuant to the Biologics Price Competition and Innovation Act.
Womble Bond Dickinson
The key to any future advancement lies in better diagnostic tools.
Holland & Knight
Following a final vote in the U.S. House of Representatives on Wednesday morning, Dec. 20, 2017, Congress sent the Tax Cuts and Jobs Act (H.R. 1) to President Donald Trump's desk.
Holland & Knight
On March 27, 2017, the OIG released a 54-page guidance document regarding how to measure the effectiveness of a compliance program.
Ropes & Gray LLP
What are the legal implications of using social media and mobile applications in clinical trials and the recent developments impacting research fraud investigations?
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
A draft bill recently introduced in the U.S. Senate serves as a good reminder that compliance with data breach reporting requirements is critical.
Ropes & Gray LLP
The FDA also announced a Jan. 30, 2018, public workshop on the progress of the Software Precertification Pilot Program.
Archer & Greiner P.C.
New Jersey's economic recovery from the Great Recession has been among the slowest in the nation.
Arnold & Porter Kaye Scholer LLP
While congressional Republicans safely hold the majority, we anticipate strong efforts to advance their legislative agenda.
Carlson, Caspers, Vandenburgh, Lindquist & Schuman, P.A.
Recently, the Federal Circuit reversed a jury decision upholding the validity of two Amgen patents directed to a large genus of antibodies that reduce LDL cholesterol.
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