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Buchanan Ingersoll & Rooney PC
Last week, the Federal Circuit held an oral argument that may have future implications for Section viii Carve-Outs in Amarin Pharmaceuticals, Inc. v. Hikma Pharmaceuticals...
Diaz Trade Law
Last week, FDA's Center for Tobacco Products (CTP) announced the release of its Searchable Tobacco Products Database.
Goodwin Procter LLP
On April 4, 2024, Bristol Myers Squibb ("BMS") and 2seventy bio, Inc. announced that the FDA has approved ABECMA (idecabtagene vicleucel) for the treatment of adult patients with relapsed ...
Dickinson Wright PLLC
The Food and Drug Administration regulates foods and beverages, drugs and medical devices, biologics, dietary supplements, tobacco products, veterinary products, and cosmetics.
Akin Gump Strauss Hauer & Feld LLP
The Department of Health & Human Services' Office of Inspector General (HHS OIG) and U.S. Department of Justice (DOJ) have published important guidance and recommendations for pharmaceutical...
K&L Gates
In this two-part Triage series, Gina Bertolini, Stephen Page, and Sarah Staples-Carlton discuss an old health care regulatory doctrine that has new relevance in a post-COVID world, where the delivery of care via telemedicine...
Foley & Lardner
On April 3, 2024, Senators Edward Markey (D-Mass.) and Elizabeth Warren (D-Mass.), chaired a Senate Health, Education, Labor, and Pensions (HELP) Subcommittee on Primary Health and Retirement Security field hearing...
Arnold & Porter
On Feb. 6, 2024, the U.S. FDA issued a final guidance, Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act.
Hall Benefits Law
Columbus Regional Healthcare System, Inc., a Georgia company, and a class of some 6,800 retirement plan participants, recently advised a federal district...
Goodwin Procter LLP
On April 5, the FDA granted accelerated approval to AstraZeneca and Daiichi Sankyo's ENHERTU (trastuzumab deruxtecan) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
Arnold & Porter
There are several aspects of the pharmaceutical industry's potential environmental footprint. Research and development require sophisticated equipment, controlled environments, and specialised materials.
Holland & Knight
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector.
Jones Day
The Situation: The Anti-Kickback Statute ("AKS") is a federal criminal statute that prohibits "knowingly and willfully" offering or paying remuneration to induce a person to order or make a referral...
Jones Day
In February 2024, the Department of Justice ("DOJ") announced the results of its 2023 False Claims Act ("FCA") enforcement efforts. Through those efforts, it obtained more than $2.6 billion in overall...
Jones Day
Health care providers in California should carefully monitor OHCA's activities and begin to plan for coming changes in their relations with health plans, health insurers, and other payers.
Perkins Coie LLP
On April 3, 2024, FDA published Draft Guidance titled New Dietary Ingredient Notification Master Files for Dietary Supplements (the Draft Guidance).
Foley Hoag LLP
Six months into the fiscal year, Congress has finally passed FY2024 appropriations. It was a painstaking process, which many expected to include policy victories that both sides could celebrate.
Arnold & Porter
In an effort to limit challenges for patient access, patient adherence to recommended treatment, or adoption of innovative products and services, providers, suppliers, and product manufacturers seek ways to address such roadblocks.
Arnold & Porter
11. COVID-19 and Life Sciences, the US government has used a wide variety of
public procurement and funding strategies for needed medical
countermeasures during the pandemic.
Arnold & Porter
The Department of Justice (DOJ) is breathing new life into False Claims Act (FCA) enforcement based on the Stark Law (Stark), 42 U.S.C. § 1395nn, also known as the Physician Self-Referral Law.
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