LATEST ARTICLES
United States
Wiley Rein
Legislation aiming to reform the regulation of pharmacy benefit managers (PBMs) remains on the horizon on both the federal and state levels.
Holland & Knight
The U.S. Food and Drug Administration (FDA or Agency) announced on April 29, 2024, in a forthcoming and long-awaited final rule...
Ogletree, Deakins, Nash, Smoak & Stewart
On April 30, 2024, following a months-long process, the U.S. Department of Justice (DOJ) circulated a proposal to reclassify marijuana from a Schedule I to a Schedule III controlled substance.
Sheppard Mullin Richter & Hampton
Yesterday, the Food & Drug Administration ("FDA" or "the Agency") issued a highly anticipated – and highly controversial – final rule, which rolls out a four-year...
Goodwin Procter LLP
On April 29, 2024, the U.S Food and Drug Administration (FDA) announced its final rule on Laboratory Developed Tests (LDTs).
Foley & Lardner
Antibody-drug conjugate is a promising class of cancer treatments with accelerating U.S. Food and Drug Administration approval and rapidly growing market size as discussed in previous articles in this series.
Sheppard Mullin Richter & Hampton
The Biden administration recently determined that it has the right to seize patents covering certain high-priced medicines, in an apparent effort to take a more aggressive approach to lowering drug prices.
Mintz
Rachel said, "Despite the case being the first to reach a circuit court among the several lawsuits fighting the program, the issues on appeal are ‘unique' to NICA and will have relatively little impact on the other cases.
Bass, Berry & Sims
Demand for cannabidiol (CBD) products continues to climb, and the market has risen to the occasion. There is now a robust array of foods, oils, lotions, capsules and cosmetics...
McGlinchey Stafford
At the White House last Friday, Vice President Kamala Harris spoke at a meeting with people who received pardons from President Joe Biden for marijuana-related offenses.
Proskauer Rose LLP
On Thursday, April 18, the Department of Justice ("DOJ"), the Federal Trade Commission ("FTC"), and the Department of Health and Human Services...
Perkins Coie LLP
USDA's Agricultural Marketing Service (USDA-AMS) recently published a Request for Information soliciting stakeholder input on the electronic or digital link disclosure option for bioengineered...
Kramer Levin Naftalis & Frankel LLP
On July 28, 2021, the Food and Drug Administration (FDA) approved the first interchangeable biosimilar product...
Bass, Berry & Sims
Despite the recent downward trend in DOJ healthcare industry settlements, the first quarter of 2024 saw many noteworthy False Claims Act (FCA) and civil healthcare fraud settlements...
Akin Gump Strauss Hauer & Feld LLP
The upcoming election, and the approaching end of the President's four-year term, introduce additional dynamics into the agencies' rulemaking process and even the guidance process.
Venable LLP
According to an April 2024 press release, Alvotech and Teva's Selarsdi™ (ustekinumab-aekn) was approved by the FDA on April 16 as a biosimilar of Janssen / Johnson & Johnson's Stelara® (ustekinumab).
Foley & Lardner
The U.S. Food and Drug Administration (FDA) recently doubled down on its January 26, 2023 position that existing regulatory pathways for foods and dietary supplements are not appropriate to manage...
Foley & Lardner
The Office of Inspector General (OIG) recently issued a new favorable advisory opinion regarding patient assistance programs (PAP) for 12 specific disease funds. PAPs help patients pay high cost-sharing...
Crowell & Moring LLP
As reported in an earlier Client Alert, on November 7, 2023, the Federal Trade Commission challenged 100 patents as improperly listed in the Food and Drug Administration's "Approved Drug Products...
Sheppard Mullin Richter & Hampton
On April 2, the FDA issued a warning letter to Agena Bioscience Inc., alleging its product, intended for research use only (RUO)...
Mondaq Webinars
FREE News Alerts
Sign Up for our free News Alerts - All the latest articles on your chosen topics condensed into a free bi-weekly email.
Comparative Guides
Curated Content
World Trade And Invasion, One Year Later – Are We On The Brink Of A New World Order?
Braumiller Law Group, PLLC
Braumiller Law Group, PLLC
Popular Contributors
Crowley Law LLC
United States
Kerr Russell & Weber
United States
Schiller DuCanto & Fleck LLP
United States
Upcoming Events
MAY07
MAY08
Mondaq Advice Centres
