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Food and Drugs Law
European Union
Keller & Heckman
Per the decree that made the law official, the ban was set to take effect on October 1, 2022.
United States
Shulman Rogers
On July 13, 2022, D.C. Mayor Muriel Bowser signed the Cannabis Employment Protections Amendment Act of 2022, which will become law after a 60-day congressional review period.
Keller & Heckman
On August 3, 2022, FDA announced the establishment of the Laboratory Accreditation for Analyses of Foods (LAAF) program Dashboard. The LAAF Dashboard will serve as a public registry listing...
Goodwin Procter LLP
Litigation involving drug price reporting under the Medicaid Drug Rebate Program (MDRP)1 has been very active in 2022. Most recently, on August 3, 2022, an Illinois federal jury...
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
On July 21, 2022, the FDA issued draft guidance titled "Evaluation of Therapeutic Equivalence."
Foley & Lardner
On July 6, the FDA revised its emergency use authorization (EUA) for the COVID-19 antiviral treatment PaxlovidTM (nirmatrelvir and ritonavir) to allow prescribing by pharmacists for quicker and easier access for patients.
Debevoise & Plimpton
The Supreme Court issued a number of groundbreaking decisions over the course of the last year, many of which impact the healthcare and life science industries.
Keller & Heckman
On August 1, the USDA's FSIS announced that it will declare Salmonella an adulterant in breaded and stuffed raw chicken products. Breaded and stuffed raw chicken products...
Sheppard Mullin Richter & Hampton
The United States' recent False Claims Act ("FCA") prosecution in United States v. Prometheus Group, et al., is a reminder that the government will use the FCA to target medical device manufacturers...
Rothwell, Figg, Ernst & Manbeck, P.C.
On August 2, 2022, Coherus BioSciences announced that the U.S. Food and Drug Administration (FDA) has approved CIMERLI™ (ranibizumab-eqrn) as a biosimilar product interchangeable...
Goodwin Procter LLP
On August 1, 2022, Fresenius Kabi announced that the FDA accepted for review its Biologics License Application (BLA) for MSB11456, a biosimilar candidate for ACTEMRA (tocilizumab).
Keller & Heckman
FDA issued final guidance regarding its decision to exercise enforcement discretion with respect to the sale and distribution of dietary supplements containing N-acetyl-L-cysteine (NAC).
Cooley LLP
On June 24, 2022, the US Food and Drug Administration issued a draft guidance document on the Considerations for Rescinding Breakthrough Therapy Designation.
Jones Day
The Situation: Recent developments in the patent landscape of Clustered Regularly Interspaced Short Palindromic Repeats ("CRISPR")
Stites & Harbison PLLC
In a recent win for healthcare practitioners, the Supreme Court in Ruan v. United States held that, to convict individuals of violating the Controlled Substances Act...
Goodwin Procter LLP
President Biden's Executive Order on Promoting Competition in the American Economy, 86 FR 36987 (2021), expressed concerns about the patent system being misused...
Buchanan Ingersoll & Rooney PC
Last year the Federal Trade Commission (FTC) set up a Pharma Taskforce (Taskforce) to review and update how pharmaceutical mergers are reviewed.
Freeman Mathis & Gary
On July 27, 2022, the Massachusetts Supreme Judicial Court of ("SJC") held that food delivery app drivers do not fall within the narrow category of employees who are exempt from arbitration...
Important developments related to required price reporting to Medicare for clinical laboratories under the Protecting Access to Medicare Act of 2014 (PAMA) have recently occurred.
Keller & Heckman
On July 26, 2022, FDA announced that it would hold a webinar for stakeholders to discuss Food Facility Registration, Biennial Renewal, and obtaining an acceptable Unique Facility Identifier.
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