Agency IQ

DECEMBER 15, 2023

For this routine MUR, EPA will only consider new methods or method revisions for which a complete, acceptable method package has been received by January 7, 2022. These standards were vacated on 7/24/2001 and on 2/13/2002. This routine Methods Update Rule (rMUR) was proposed in February 2023. EPA, 955 F.3d 3d 1088 (D.C. 2020) (“LEAN”).

Regulations 40

Regulations Compliance Production Government 40

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

Regulations 40

Regulations Compliance Production Science 40

Agency IQ

JULY 28, 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. But despite the law’s age, it is not yet fully operational.

FDA 40

FDA Science Biosimilars Regulations 40

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. Nature (2002). At that time, even though animal breeders had long exploited regularities in the patterns of inheritance, the principles underlying heredity remained mysterious.

Laboratories 117

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 ).

FDA 40

FDA Packaging Laboratories Testimonials 40

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.

Production 52

Production International Trials Government 52

Drug & Device Law

MAY 17, 2023

In 2009, a federal jury found beyond a reasonable doubt that the CEO acted with intent to defraud when he directed his company to issue a “false and misleading press release [in 2002] about the results of one of the Company’s clinical trials.” Bexis wrote about this criminal case here.) Or was it really so neat?

Trials 59

Trials Clinical Trials Packaging Drugs 59

Drug & Device Law

JUNE 6, 2022

2002) (the “causal link is broken” where the implanting surgeon “would have taken the same course of action even with the information the plaintiff contends should have been provided”) (citation and quotation marks omitted) (applying Georgia law); Ralston v. even with the addition of the language now found in the package insert”); McDaniel v.

Testimonials 59

Testimonials Production Pharmaceuticals Drugs 59

Drug & Device Law

MAY 30, 2022

1988) (no causation where prescriber “read the warning on the package insert and decided not to warn the [plaintiffs]”); Dunn v. 2002), aff’d , 356 F.3d Accord Wyeth Laboratories, Inc. Fortenberry , 530 So.2d 2d 688, 691 (Miss. Lederle Laboratories , 328 N.W.2d 2d 576, 583-84 (Mich. American Cyanamid Co. , 3d 496, 514 (6th Cir.

Testimonials 59

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).

Vaccine 59

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.

Testimonials 59

Testimonials Licensing Licensing FDA 59

Drug & Device Law

FEBRUARY 19, 2024

Ortho Pharmaceutical Corp., 2d 522, 528 (Or. 1974), but a subsequent decision held that the Oregon product liability statute, which basically adopted Restatement §402A in toto , meant that the rule did not apply in strict liability cases, because §402A did not reference the rule. Griffith v. Blatt , 51 P.3d 3d 1256, 1262 (Or. 201.100(a-b).

Licensing 52

Licensing Licensing Regulations FDA 52