On March 17, 2025, a bipartisan group of senators introduced two bills intended to decrease the cost of prescription drugs. The sponsors include Chuck Grassley (R-Iowa), John Cornyn (R-Texas), Richard Blumenthal (D-Conn.),...more
On November 21, 2024, the FDA’s Center for Devices and Radiological Health (CDRH) announced a pilot communications program for improving the timeliness for communicating high-risk recalls. The CDRH intends for the pilot...more
The Food and Drug Administration (FDA) recently issued warning letters to two third-party nonclinical testing laboratories. The FDA cited the laboratories for “oversight failures and animal care violations that raise concerns...more
On August 19, 2024, the Association for Molecular Pathology (AMP) sued the FDA to challenge a new rule that allows the FDA to regulate laboratory developed tests (LDTs). The rule, which became effective on July 5, 2024,...more
On April 29, 2023, the FDA announced a final rule on regulation of laboratory developed tests (LDTs). The rule explicitly categorizes in vitro diagnostic products (IVDs) intended for clinical use as medical devices, which are...more
The looming government shutdown will likely slow the pace of work at the FDA. The federal government will shut down on October 1, 2023 unless a deal is reached. In the event of a shutdown, 19% of FDA employees would be...more
On September 26, 2023, Nexus Pharmaceuticals, LLC announced that it had received approval from the U.S. Food and Drug Administration (FDA) for Fluorescein Injection, USP. Nexus Pharmaceuticals is a maker of generic drugs....more
Volvo Penta of the Americas, LLC, v. Brunswick Corp.
Before Moore, Lourie, and Cunningham. Appeal from the Patent Trial and Appeal Board.
Summary: The Board must consider the combined weight of multiple objective...more
On April 21, 2023, the Supreme Court granted a stay in Alliance for Hippocratic Medicine v. FDA, a case concerning the Food and Drug Administration’s approval of and access to the widely used abortion pill mifepristone. The...more
The FDA recently announced release of final transition guidance documents for medical diagnostic devices targeting COVID-19. The transition guidance documents are intended to guide COVID-19 diagnostic device manufactures as...more
4/3/2023
/ Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Diagnostic Tests ,
Emergency Use Authorization (EUA) ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Healthcare ,
Marketing Authorization Application ,
Medical Devices ,
Pharmaceutical Industry ,
Public Health Emergency
GOOGLE LLC v. HAMMOND DEVELOPMENT INTERNATIONAL, INC. -
Before Moore, Chen, and Stoll. Appeal from the Patent Trial and Appeal Board. -
Summary: Collateral estoppel applies to IPRs where differences in claims do not...more
Summary: An ANDA was held not to infringe asserted claims because the ANDA specifies pH ranges that fall outside of those recited in the asserted claims....more
Boston Scientific announced on August 15, 2022, that it acquired Obsidio, Inc. for an undisclosed fee. Obsidio has technology called the Gel Embolic Material (GEM™), which is used in minimally invasive blood vessel...more
GENUINE ENABLING TECHNOLOGY LLC V. NINTENDO CO., LTD -
Before Newman, Reyna, and Stoll. Appeal from the Western District of
Washington.
Summary: A finding of prosecution disclaimer must be supported by an unambiguous...more
(Mar. 31, 2022) Last Friday, ImmunoGen won an appeal at the Federal Circuit in ImmunoGen, Inc. v. Hirshfeld. The lawsuit is a civil action to order the granting of U.S. Application No. 14/509,809 (‘809), titled “Anti-FOLR...more