Agency IQ

JUNE 16, 2023

Final Rule Stage Clean Water Act Section 401: Water Quality Certification 2040-AG12 August 2023 Clean Water Act (CWA) section 401 provides States and Tribes with a powerful tool to protect the quality of their waters from adverse impacts resulting from federally licensed or permitted projects.

Regulations 40

Regulations Compliance Production Science 40

Drug & Device Law

JULY 31, 2023

2001); Isham v. 2001), relied on these other statutes to hold that a road could not be a “product”). 2001) (applying Illinois law); Serpico v. However, licensed software can be a UCC sale of “goods.” Smith rejected plaintiff’s analogy between books and drug package inserts. Huntington Ingalls Inc. , Engelhardt v.

Production 52

Production International Trials Government 52

Drug & Device Law

JANUARY 4, 2024

by] authoriz[ing] the [HHS] Secretary to limit legal liability for losses relating to the administration of medical countermeasures such as diagnostics, treatments, and vaccines. . . . 247d-6d(b)(8). Plaintiffs Legal Committee , 531 U.S.

Vaccine 59

Vaccine FDA FDA Approval Pharmacy 59

Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. 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. . . . There’s a reason why prescribing physicians and implanting surgeons are called “learned” intermediaries.

Testimonials 59

Testimonials Doctors Production Laboratories 59