Agency IQ

JUNE 16, 2023

Section 2008 Improved Consumer Confidence Reports amended the Safe Drinking Water Act section 1414(c)(4) to revise requirements for Consumer Confidence Reports (CCR). Amendments to TSCA in 2016 included several new provisions concerning the assertion and Agency review and treatment of CBI claims.

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Regulations Compliance Production Science 40

Drug Discovery World

SEPTEMBER 29, 2022

While there are steps that individuals can take to reduce their risk of contracting CMV, there are no existing treatments or preventative vaccines to address CMV transmission, the subsequent infection or the longer-term manifestations of infection. Progression of vaccines . 1974 Jan 5;1(7845):1-5. doi: 10.1016/s0140-6736(74)92997-3.

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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.

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Regulations Compliance Engineering Government 40

Drug & Device Law

JULY 31, 2023

2008 WL 11344752, at *2 (D. April 22, 2008); Isham v. 2008 WL 2622791, at *4 (N.D. July, 1, 2008) (“provision of a manual for software does not convert the transaction from one for a software service to one for both tangible goods and service”). 2008) (all quoting and following Pierson definition of product).

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Production International Trials Government 52

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. 2008) (applying Texas law and discussed here ), several times. Wyeth Pharmaceuticals , 526 F.3d

Testimonials 59

Testimonials Production Pharmaceuticals Treatment 59

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. 440 (2008), in the face of a contrary ruling from the Sixth Circuit in Garcia v.

FDA Approval 64

FDA Approval FDA Regulations Production 64

Drug & Device Law

MARCH 23, 2023

The typically gentle treatment from the MDL did not last and the plaintiff ended up with her sole case-specific causation expert excluded and her case tossed on summary judgment. (Not Southern Source Packaging, LLC , 568 F. As one of the cited decisions put it, “Courts distinguish ‘true supplementation’ (e.g., 2d 624, 631 (E.D.N.C.

Testimonials 59

Testimonials Packaging Compliance Trials 59

Drug & Device Law

MAY 30, 2022

This scenario was the “third hypothetical” in our “ Learned Intermediary Rule 201 ” post back in 2008. 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. Our 2008 post discussed Ackermann v.

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