Agency IQ

MARCH 29, 2024

The AWIA, Section 2009(a), also revises the scope of a consolidation plan under the Safe Drinking Water Act (SDWA), subsection 1414(h)(1), to include a contract for significant managerial or administrative functions of a PWS.

Regulations 40

Regulations Compliance Production Government 40

Agency IQ

FEBRUARY 2, 2024

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.

Regulations 40

Regulations Compliance Engineering Government 40

Codon

FEBRUARY 2, 2025

Although this had less to do with advanced microbial understanding, and more to do with observation and folk wisdom, some of the elements of these treatments did indeed help — especially those relating to the curative nature of good air quality. A sanatorium for tuberculosis patients in St. Blasien, Germany (1911).

Disease 79

Disease Vaccine Nurses Engineering 79

Codon

FEBRUARY 23, 2025

government issued a limited waiver that let PEPFAR resume HIV treatments abroad, pending further guidance. Researcher Jerome Horwitz at the Michigan Cancer Foundation developed it as a potential cancer treatment by chemically-modifying thymine, a DNA building block. By February, the U.S.

Clinical Trials 68

Clinical Trials Virus Vaccine Trials 68

Drug & Device Law

JULY 31, 2023

2009 WL 1142570, at *8 (Conn. April 1, 2009) (contract to revise and encrypt plaintiff’s existing software did not involve a UCC good); Bobryk v. 2009); see also Data Processing Services, Inc. 2009), aff’d in part & rev’d in part on irrelevant grounds , 659 F.3d Thomas Nelson Publishing , 2009 WL 612385, at *2 (E.D.

Production 52

Production Trials International Government 52

Drug & Device Law

MAY 4, 2023

Relatedly, the claim for “false marketing”—the court’s term, whereas the OPLA calls it “Product conforming to representation made by manufacturer” and it would usually be called “misrepresentation”—was really a re-packaged warnings claim. Warner-Lambert & Co. , 3d 85, 98 (2d Cir. 2006), aff’d by equally divided court , 552 U.S.

FDA Approval 64

FDA Approval FDA Regulations Production 64

Drug & Device Law

NOVEMBER 7, 2022

The defendant’s drug in Wilkins was the only FDA-approved medication for the treatment of a rare disease ( Fabry Disease ). Back in 2009, the defendant’s “production stalled due to various problems at its manufacturing facility.” Nowhere does the package insert state that a lower dosage is FDA-approved. 2022 WL 4237528, at *2.

Production 72

Production FDA Approval Packaging Doctors 72

Drug & Device Law

JUNE 6, 2022

Thus a confident learned intermediary’s testimony will defeat causation as a matter of law by stating that, notwithstanding a poor result, the treatment provided was standard of care, and even in hindsight they would not do anything different. 2009), reversed a plaintiff’s verdict for entry of judgment n.o.v. Hoffmann-La Roche, Inc.

Testimonials 59

Testimonials Production Pharmaceuticals Drugs 59

Drug & Device Law

MAY 30, 2022

That oncologists prescribing lifesaving standard-of-care treatment in the face of “aggressive cancer” are not impressed by a risk of – permanent hair loss – is not surprising. 1988) (no causation where prescriber “read the warning on the package insert and decided not to warn the [plaintiffs]”); Dunn v. at *3 (emphasis original).

Testimonials 59

Testimonials Doctors Production Laboratories 59