Agency IQ

JUNE 2, 2023

FDA unveils long-awaited Patient Medication Information proposed rule Since 2017, the FDA has been working on a proposal to create a new type of patient-focused labeling for certain outpatient drug products that would be specifically targeted for patient use. The FDA recently concluded its work on a proposed rule focused on PMI.

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Agency IQ

JUNE 16, 2023

The Iron and Steel Manufacturing Facilities NESHAP was promulgated pursuant to section 112(d) of the Clean Air Act (CAA) on May 20, 2003, and subsequently amended on July 13, 2006. The Coke Ovens: Pushing, Quenching, and Battery Stacks NESHAP, subpart CCCCC, was promulgated pursuant to section 112(d) of the CAA on April 14, 2003.

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Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 23, 37 (2003) (“the phrase refers to the producer of the tangible goods that are offered for sale, and not to the author of any idea, concept, or communication embodied in those goods”). 2003), review denied (Cal.

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Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. That means that prescribers can make risk/benefit analyses to determine what prescription drugs or medical devices their patients need. That “common and widely known side effect” of many “chemotherapy drugs,” id. Two other oldies but goodies are Plummer v.

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Drug & Device Law

JANUARY 4, 2024

2003); Birdsong v. The Complaint nowhere alleges that either the persons allegedly targeted or the persons purportedly targeting their “wild conspiracy theories” have any connection to Texas, which leaves us wondering how the Texas Deceptive Trade Practices Act (“DTPA”) could possibly apply. See Henry Schein, Inc. Stromboe , 102 S.W.3d

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