United States: Food and Drugs Law

Across Pennsylvania, independent pharmacies are seeing a pronounced increase in inspections and investigations initiated by the Pennsylvania State Board of Pharmacy.

On 4 June, EU Member States, meeting in the Council of the European Union (‘Council'), have agreed on a position on the pharmaceutical reform package.

Of the emerging litigation topics across America, one of the more burdensome on our judicial system involves PFAS, or per- and polyfluoroalkyl substances. Though PFAS have been around since the mid-20th century...

On 4 June, EU Member States, meeting in the Council of the European Union (‘Council'), have agreed on a position on the pharmaceutical reform package.

On May 6, 2025, with almost no discernible press or public announcements, the Dental Trade Alliance (DTA) – a trade association of dental suppliers and service providers...

Shortly following its announcement of sweeping changes to RADV audits, CMS shared industry guidance last week regarding upcoming...

Across Pennsylvania, independent pharmacies are seeing a pronounced increase in inspections and investigations initiated by the Pennsylvania State Board of Pharmacy.

On May 6, 2025, with almost no discernible press or public announcements, the Dental Trade Alliance (DTA) – a trade association of dental suppliers and service providers...

Of the emerging litigation topics across America, one of the more burdensome on our judicial system involves PFAS, or per- and polyfluoroalkyl substances. Though PFAS have been around since the mid-20th century...

In Otsuka Pharmaceutical Co. v. Sandoz, Inc., the Federal Circuit upheld the district court’s determination that the claims at issue were neither obvious nor invalid under the doctrine of obviousness-type double patenting based on a "lead compound" approach to the obviousness determinations.

After the Supreme Court decided that the personalized medicine method claims at issue in Mayo Collaborative Services v. Prometheus Laboratories, Inc. did not satisfy the patent eligibility requirements of 35 USC § 101.

GlaxoSmithKline and Genentech have settled a U.S. lawsuit related to Genentech's Cabilly II (US 6,331,415) and Cabilly III (US 7,923,221) patents.