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 ...
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Pharmaceutical industry stakeholders know that drug prices, market competition, supply chain challenges, and shortages of critical drug products have been top of mind for policymakers in recent years.
BakerHostetler
The herbicide glyphosate, available in commercial form from Monsanto as "Roundup" since the early 1970s, had by 2007 become the No. 1 herbicide ...
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
It has been a few months since we reported on Federal Court wranglings with the Biologics Price Competition and Innovation Act, or BPCIA, which created the nation's abbreviated marketing pathway for biosimilar products
Poyner Spruill LLP
The 2018 State Medical Facilities Plan (SMFP) was approved by Governor Cooper on December 11, 2017, and has been issued effective January 1, 2018.
Reed Smith
On January 18, 2018, HHS announced it has established a new Conscience and Religious Freedom Division within the HHS Office for Civil Rights (OCR).
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 ...
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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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