Agency IQ

JUNE 16, 2023

Perhaps the most important addition to FDA’s agenda is a proposed rule intended to clarify that Laboratory Developed Tests (LDTs) are to be regulated as medical devices under the Federal Food, Drug and Cosmetic Act (FD&C Act). Read our analysis of that rule here and here. ]

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The Pharma Data

MARCH 31, 2023

This is enabled by the signing of a voluntary licensing agreement for patents relating to cabotegravir LA for PrEP with MPP in July 2022. Trademarks are owned by or licensed to the ViiV Healthcare group of companies. According to UNAIDS’ latest estimates, approximately 1.5 According to UNAIDS’ latest estimates, approximately 1.5

Licensing 40

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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 AWIA, section 2009(a), also revises the scope of a consolidation plan under the Safe Drinking Water Act (SDWA), subsection 1414(h)(1), to include a contract for significant managerial or administrative functions of a PWS. This rule is the second of two rulemakings (Phase II) that EPA is undertaking to update its FOIA regulations.

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Agency IQ

JULY 28, 2023

DSCSA implementation – Down to the wire as a deadline draws near: The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 as part of the Drug Quality and Security Act (DQSA), following several drug counterfeiting scandals in which falsified medical products entered the supply chain.

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Drug & Device Law

JULY 31, 2023

2009 WL 1142570, at *8 (Conn. April 1, 2009) (contract to revise and encrypt plaintiff’s existing software did not involve a UCC good); Bobryk v. 2009); see also Data Processing Services, Inc. 2009), aff’d in part & rev’d in part on irrelevant grounds , 659 F.3d Thomas Nelson Publishing , 2009 WL 612385, at *2 (E.D.

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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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