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. This routine Methods Update Rule (rMUR) was proposed in February 2023. EPA is not considering methods for new analytes in this routine MUR. EPA, 955 F.3d 3d 1088 (D.C.

Regulations 40

Regulations Compliance Production Government 40

Agency IQ

JUNE 16, 2023

For increased flexibility in bringing PIPs to market, a developer can also submit both. The Primary Copper Smelting NESHAP, subpart QQQ, was promulgated pursuant to section 112(d) of the Clean Air Act (CAA) on June 12, 2002. EPA is reviewing the comments received and is planning to issue a final rule. EPA, 955 F.3d 3d 1088 (D.C.

Regulations 40

Regulations Compliance Production Science 40

Agency IQ

JULY 28, 2023

On March 27, the FDA finalized a transition guidance document covering products that had been marketed under enforcement discretion policies during the PHE. First, by March 2021, manufacturers were expected to conclude a risk assessment of their approved or marketed products to assess the risk of nitrosamines.

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

Drug & Device Law

JULY 31, 2023

no[r] a marketing product” under Lanham Act). 2002), held that Connecticut law would follow the definition of “product” as “tangible personal property distributed commercially for use or consumption.” Leading Market Technologies, Inc. , Gray Loon Outdoor Marketing. Paragon 28, Inc. 2019 WL 4751807, at *8 (D. 2d 1264 (D.

Production 52

Production International Trials Government 52

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. 26, 2015); In re Plavix Product & Marketing Cases , 2017 WL 2882212, at *3 (Cal.

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. In In re Plavix Marketing, Sales Practices & Products Liability Litigation , 2017 WL 4838842 at *6-7 (D.N.J. 2002), aff’d , 356 F.3d Accord Wyeth Laboratories, Inc. Fortenberry , 530 So.2d

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. purchase, marketing, promotion, . . development, clinical testing or investigation, distribution, purchase, marketing, promotion, sale, purchase, or use” of an immune covered countermeasure. See Henry Schein, Inc. Stromboe , 102 S.W.3d

Vaccine 59

Vaccine FDA FDA Approval Production 59

Drug & Device Law

FEBRUARY 19, 2024

Often, if not always, the “special controls” for a given FDA regulated product will specify that said product can only be marketed for prescription use and is thus exempt from providing “adequate directions for use” to lay patients. Ortho Pharmaceutical Corp., 2d 522, 528 (Or. Griffith v. Blatt , 51 P.3d 3d 1256, 1262 (Or. 201.100(a-b).

Licensing 52

Licensing Licensing Regulations FDA 52