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 . Frontiers in cellular and infection microbiology, 130. .

Vaccine 130

Vaccine Immune Response Virus Disease 130

Agency IQ

DECEMBER 15, 2023

The allowance or “variance” to the prohibition on the open burning of hazardous waste was established at a time when there were no alternatives to the safe treatment of waste explosives. 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 Production Government 40

Agency IQ

JUNE 16, 2023

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. This rule is the second of two rulemakings (Phase II) that EPA is undertaking to update its FOIA regulations.

Regulations 40

Regulations Compliance Production Science 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

Agency IQ

JULY 28, 2023

September 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020. 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

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 International Trials 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

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 Treatment 59

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

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