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 ...
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.
Jones Day
Public Meeting of FDA, USDA, and DHHS to provide information and receive public comments on agenda items and draft U.S. positions to be discussed at the 50th Session of the Codex Committee ...
Jones Day
In the November 30, 2017, Federal Register, USDA's FNS issued an interim final rule extending through school year 2018-2019 three menu-planning flexibilities ...
Jones Day
In the December 11, 2017, Federal Register, USDA's AMS announced a public hearing that was finally held on December 14, 2017, to consider a proposal ...
Jones Day
In the December 11, 2017, Federal Register, USDA's AMS adopted a final rule to amend the definition of "judge" in the rules of practice and procedure to formulate ...
Jones Day
In the January 4, 2018, Federal Register, USDA announced its withdrawal of certain advance notice of proposed rulemakings and proposed rules that were either published in the Federal Register ...
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Morgan Lewis
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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.
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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
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Archer & Greiner P.C.
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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.
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