Agency IQ

JUNE 16, 2023

The Primary Copper Smelting NESHAP, subpart QQQ, was promulgated pursuant to section 112(d) of the Clean Air Act (CAA) on June 12, 2002. The Rubber Tire Manufacturing NESHAP, subpart XXXX, was promulgated pursuant to section 112(d) of the Clean Air Act (CAA) on July 9, 2002, with corrections promulgated on March 12, 2003. EPA, 955 F.3d

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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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Codon

JUNE 2, 2024

That is—until the Austrian monk Gregor Mendel showed that traits are passed from parent to offspring in discrete, independently assorted packages. Without mouse models, we may never have developed polio and meningitis vaccines, organ transplants, GLP-1 drugs, gene therapies , or any other number of transformative treatments.

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Laboratories Research Disease Science 117

Agency IQ

JULY 13, 2023

That law built upon several other previous laws, including the Public Health Threats and Emergencies Act of 2000, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Project BioShield Act of 2004 ( see a Congressional Research Service report on its legislative history here ).

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Drug & Device Law

JULY 31, 2023

2002), held that a videogame could not be a “product” for strict liability purposes. “[I]n considering whether to recognize a new tort recovery theory, the Colorado courts give great weight to the theory’s impact on free expression.” Connecticut Connecticut’s products liability statute does not define the term “product.” See Conn.

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Production International Trials Government 52

Drug & Device Law

MAY 17, 2023

So imagine our giddiness when Bexis flipped us a Delaware Chancery Court case involving a criminally convicted drug executive who sought indemnification from his former company based on a pardon from former President Trump. In Intermune , the plaintiff was a drug manufacturer. In Intermune , the plaintiff was a drug manufacturer.

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Drug & Device Law

JUNE 6, 2022

at 172 (“continued to prescribe” the drug “a lot” and “believed it to be an effective drug for many of her patients”). where the prescriber: testified that he would still be willing to prescribe [the drug] to his patients even if there was evidence showing that it could cause [plaintiff’s condition] in rare cases. 3d 75 (Fla.

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Drug & Device Law

MAY 30, 2022

That means that prescribers can make risk/benefit analyses to determine what prescription drugs or medical devices their patients need. W]e believe that a drug manufacturer cannot be required legally to foresee that a licensed physician will disregard express warnings regarding a drug’s use. . . . their patients.

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Testimonials Doctors Production Laboratories 59

Drug & Device Law

JANUARY 4, 2024

2002); Tracker Marine, L.P. 2002 WL 32830975, at *4 (Tex. May 15, 2002); Bass v. See Henry Schein, Inc. Stromboe , 102 S.W.3d 3d 675, 698 (Tex. Ogle , 108 S.W.3d 3d 349, 358 (Tex. 2003); Birdsong v. Toyota Motor Credit Corp. Hendrix , 931 F. 523, 529 (S.D. 1996) (all refusing to apply DTPA extraterritorially). 247d-6d(b)(8).

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Vaccine FDA FDA Approval Production 59

Drug & Device Law

JUNE 13, 2022

That requirement comes with an exception: Provided, however , That such information may be omitted from the dispensing package if, but only if, the article is a device for which directions, hazards, warnings, and other information are commonly known to practitioners licensed by law to use the device. 801.109(c). Bard, Inc. , 3d at 1286.

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Testimonials Licensing Licensing FDA 59

Drug & Device Law

FEBRUARY 19, 2024

For both prescription drugs and medical devices, FDA regulations provide that direct-to-patient warnings – called “adequate directions for use” – are not necessary for drugs or devices that are available only with a physician’s prescription. For drugs, the relevant regulation is 21 C.F.R. Ortho Pharmaceutical Corp.,

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Licensing Licensing Regulations FDA 52