2008, Packaging and Treatment - Drug Discovery Digest

Package | Prasara Yoga

The Pharma Data

MAY 14, 2021

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Packaging

Packaging Production Doctors International

Discovering an Antimalarial Drug in Mao’s China

Codon

APRIL 9, 2024

However, the blandly clinical package of artemisinin and artesunate tablets reveals little about how the key compound was first discovered. In response to the precipitous rise in incidence, governments on both sides of the Pacific began a systematized search for antimalarial treatments. Nobody had an answer.

Drugs

Drugs Science Research Doctors

Analysis Chemical Thank You What we expect EU chemical regulators to do in September 2024

Agency IQ

AUGUST 30, 2024

CAD and CMRD) are coming to a close this month (CLP is the acronym for Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures; CAD and CMRD stand for chemical agents directive and carcinogens, mutagens, reprotoxic substances directive, respectively).

Regulations

Regulations Production Government Packaging

Analysis Chemical Thank You The 174 regulations the EPA is currently working on

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. Circuit granted EPA a voluntary remand in 2008 for the Agency to re-evaluate the MACT floors established in 1995 based on the D.C. EPA, 358 F.3d

Regulations

Regulations Compliance Production Government

Analysis Chemical Thank You What we expect the EPA to do in April 2024

Agency IQ

MARCH 29, 2024

The Gasoline Distribution NESHAP, subparts R and BBBBBB, were promulgated pursuant to section 112(d) of the Clean Air Act(CAA) on December 14, 1994, and January 10, 2008, respectively. Additional revisions that would impact permitting, for example, changes to definitions or references, may also be proposed for other RCRA regulatory sections.

Regulations

Regulations Compliance Production Government

Analysis Chemical Thank You What we expect the EPA to do in December 2023

Agency IQ

DECEMBER 1, 2023

The Gasoline Distribution NESHAP, subparts R and BBBBBB, were promulgated pursuant to section 112(d) of the Clean Air Act (CAA) on December 14, 1994, and January 10, 2008, respectively. In 2009, the EPA granted reconsideration on a petition to reconsider the 2008 rule and subsequently issues an administrative stay of the 2008 rule.

Regulations

Regulations Production Compliance Science

Analysis Chemical Thank You Highlights of the EPA’s Unified Agenda for Spring 2023

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.

Regulations

Regulations Compliance Production Science

Analysis Chemical Thank You What we expect the EPA to do in February

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

Regulations Compliance Engineering Government

How the Fifty States View Electronic Data as a “Product”

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).

Production

Production International Trials Government

Pretty Potent Mix In A Prescription Painkiller Preemption Decision

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

FDA Approval FDA Regulations Production

Pelvic Mesh Remand Case Fizzles Out Again

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

Testimonials Packaging Compliance Trials

Confident Learned Intermediaries Defeat Warning Causation

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

Testimonials Production Pharmaceuticals Drugs

Unimpressed Learned Intermediaries Defeat Warning Causation

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.

Testimonials

Testimonials Doctors Production Laboratories

Drug Discovery Digest

Package | Prasara Yoga

Discovering an Antimalarial Drug in Mao’s China

Trending Sources

Analysis Chemical Thank You What we expect EU chemical regulators to do in September 2024

Analysis Chemical Thank You The 174 regulations the EPA is currently working on

Analysis Chemical Thank You What we expect the EPA to do in April 2024

Analysis Chemical Thank You What we expect the EPA to do in December 2023

Analysis Chemical Thank You Highlights of the EPA’s Unified Agenda for Spring 2023

Analysis Chemical Thank You What we expect the EPA to do in February

How the Fifty States View Electronic Data as a “Product”

Pretty Potent Mix In A Prescription Painkiller Preemption Decision

Pelvic Mesh Remand Case Fizzles Out Again

Confident Learned Intermediaries Defeat Warning Causation

Unimpressed Learned Intermediaries Defeat Warning Causation

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