Mondaq USA: Food, Drugs, Healthcare, Life Sciences
Jones Day
In the November 13, 2017, and January 2, 2018, Federal Register, FDA amended the food additive regulations for food additives permitted ...
Jones Day
In the November 16, 2017, Federal Register, FDA announced the availability of a draft guidance for industry titled "Best Practices for Convening a GRAS Panel."
Jones Day
In the December 13, 2017, Federal Register, FDA announced the termination of the Food Advisory Committee, established on March 6, 1992.
Jones Day
On November 21, 2017, FDA announced the availability of a guidance for industry titled "Sanitary Transportation of Human and Animal Food: What You Need to Know About the FDA Regulation—Small Entity Compliance Guide."
Jones Day
On December 11, 2017, FDA issued a draft guidance explaining when the Agency considers a foreign food establishment's or foreign government's action to be a refusal to permit entry to inspect a food facility.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Today is the deadline for interested parties to submit comments to CMS regarding the proposed contract year 2019 Medicare Advantage and Part D regulations.
Reed Smith
Perhaps you have heard that elections have consequences. That is true not only for high-profile issues that hog the headlines on CNN and Fox News, but it is also true for drug and device litigation regulation.
Reed Smith
On December 5, 2017, the U.S. Food and Drug Administration (FDA) released the final version of its guidance entitled "Technical Considerations for Additive Manufactured Medical Devices; Guidance ...
Garvey Schubert Barer
U.S. Attorney General Jeff Sessions today rescinded the Cole Memorandum, which had directed the federal justice department to de-prioritize the prosecution of federal marijuana laws...
Foley Hoag LLP
We hope you enjoyed the holidays and New Year and are getting back into the swing of work. Speaking of work: Medicaid.
Foley & Lardner
On January 9, 2018, The Centers for Medicare & Medicaid Services (CMS) announced a new voluntary bundled payment model program – Bundled Payment for Care Improvement Advanced (BPCI Advanced).
Dentons
In a memorandum issued on January 4, 2018, Attorney General Jeff Sessions reversed an Obama-era policy that the Department of Justice (DOJ) would not devote resources to the prosecution...
Day Pitney LLP
The new model is the first advanced APM introduced by the Trump administration.
McDermott Will & Emery
Throughout 2017, the health care and life sciences industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and payment...
Troutman Sanders LLP
Coming under scrutiny in the 2017-18 session of the New York State Legislature, electronic cigarettes and other vapor products have been the subject of various proposed bills.
Sheppard Mullin Richter & Hampton
San Francisco (January 11, 2018) – The final day of the 2018 JP Morgan Healthcare Conference gave us food for thought about the topic of healthcare navigation, as well as updates on the home health sector.
Jones Day
The global trend toward digital transformation is changing the health care industry's administrative, delivery, and payment models in ways that were unimaginable just a few years ago.
Dickinson Wright PLLC
Attorney General Jeff Sessions issued a one-page memorandum on January 4, 2018 (the "Sessions Memo") rescinding both the Cole and Ogden Memoranda which essentially established a Department of Justice ("DOJ") prosecutorial safe harbor for medical marijuana businesses that complied strictly with state laws governing marijuana.
Thompson Coburn LLP
Homeopathic medicine has long occupied a niche in American culture. Since 1988, with the issuance of the Compliance Policy Guide, § 400.400, ...
Jones Day
On January 4, 2018, the U.S. Food and Drug Administration ("FDA") issued a guidance announcing that it does not intend to enforce certain provisions of four final rules implementing the FDA "FSMA".
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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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