Agency IQ

JANUARY 19, 2024

Commission unveils “one substance, one assessment” reform package The Commission has long aspired to realize its one substance, one assessment concept in the EU’s chemical regulatory regime. Data from pharmaceutical legislation is not included by default, though some specifically named pharma data relating to chemicals will be encompassed.

Packaging 40

Packaging Regulations Laboratories Animal Testing 40

Codon

MARCH 24, 2024

In the case of semaglutide, those cells are Saccharomyces cerevisiae— also known as Baker’s yeast — engineered to secrete a peptide precursor that is later purified, chemically modified, packaged into an injectable or tablet form, and then shipped around the world. Continuing this method may not scale.

Engineering 85

Engineering Vaccine Production RNA 85

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

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

A big nitrosamine deadline approaches : Unless you’ve been hiding under a rock for the last few years, you’ve probably heard about major issues that the pharmaceutical industry has been having with nitrosamine contamination. But despite the law’s age, it is not yet fully operational.

FDA 40

FDA Science Biosimilars Regulations 40

Drug & Device Law

JULY 31, 2023

Medicis Pharmaceutical Corp. , 2002), held that Connecticut law would follow the definition of “product” as “tangible personal property distributed commercially for use or consumption.” 2002 WL 432016, at *3-4 (D. March 18, 2002). Paddock Pool Construction Co. , 2d 968, 972 (Ariz. 3d 944, 949 (Ariz. 2d 1264 (D.

Production 52

Production International Trials Government 52

Drug & Device Law

JUNE 6, 2022

Bayer HealthCare Pharmaceuticals, Inc. , Wyeth Pharmaceuticals , 526 F.3d 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.

Testimonials 59

Testimonials Production Pharmaceuticals Drugs 59