2005 and Packaging - Drug Discovery Digest

Article Periodic Thank You European Commission unveils proposed ban on bisphenol A in food packaging

Agency IQ

FEBRUARY 15, 2024

European Commission unveils proposed ban on bisphenol A in food packaging The European Commission has proposed a total ban on bisphenol A and related substances for use in food contact materials. Stakeholders now have until March 8 to provide feedback on the proposal. BY SCOTT STEPHENS, MPA | FEB 12, 2024 10:42 PM CST Bisphenol A (CAS No.

Packaging

Packaging Regulations Compliance Production

Analysis Chemical Thank You Explainer: carcinogen classification in the E.U., U.S., and internationally

Agency IQ

AUGUST 18, 2023

This framework is anchored in the Classification, Labeling, and Packaging Regulation (CLP) (1272/2008/EC), the bloc’s definitive legislation on classifying substances and mixtures. The EPA initially adopted a carcinogen classification scheme in 1986 before revising it in 2005. European Union The E.U. by inhalation, but not ingestion).

International

International Regulations Packaging Animal Testing

A Roadmap for Introducing Novel Excipients: How to Approach Excipient Qualification with the FDA

The Premier Consulting Blog

NOVEMBER 16, 2022

If the excipient is not listed in the IID, then a full nonclinical qualification program in alignment with the FDA’s 2005 guidance Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients may be needed. Involving nonclinical/toxicology experts early on is key to reducing the package of studies as much as possible.

FDA

FDA Packaging Production Compliance

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Agency IQ

JANUARY 26, 2024

In response to this report, FDA researchers published extensive data on the SLEP program, reviewing the findings for 122 drugs products (3005 different lots) evaluated by the program between 1986 and 2005. In some cases, manufacturers have determined that specific drug products have limited stability when the original packaging is opened.

Science

Science FDA Production Packaging

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. It was only in 2005, after the emergence of widespread resistance of P.

Drugs

Drugs Science Research Doctors

Article FDA Thank You FDA updates set the stage for broader use of harmonized standards for safety reporting

Agency IQ

APRIL 8, 2024

Once E2D(R1) has been finalized following comments received during public consultation, the note stated that “the final changes will be published via the E2B(R3) Implementation Guide package and ICH E2B(R3) Questions and Answers document.” This week, the FDA made significant progress towards the full implementation of E2B(R3) requirements.

FDA

FDA Production Regulations Vaccine

Extraordinary General Meeting in Oncopeptides AB (publ) – Nov 03, 2020

The Pharma Data

NOVEMBER 2, 2020

Based on detailed benchmark material produced by Deloitte showing statistic and market practice from other start up oncology companies within the US, the Board of Directors of Oncopeptides believes that an equity and performance based incentive program, in line with market practice for peer companies within the US, is a vital part of an attractive (..)

Marketing

Marketing Regulations Packaging Pharmaceutical Companies

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

Agency IQ

DECEMBER 15, 2023

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. On September 14, 2018, the U.S.

Regulations

Regulations Compliance Production Government

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

Agency IQ

MARCH 29, 2024

March 2024 Standards of Performance for New Stationary Sources and Emission Guidelines for Existing Sources: Other Solid Waste Incineration Units Review (Final Rule Stage) 2060-AU60 EPA promulgated emissions standards for Other Solid Waste Incineration (OSWI) units on December 16, 2005. On September 14, 2018, the U.S.

Regulations

Regulations Compliance Production Government

Article Periodic Thank You EPA flips on Trump-era plan to exempt pyrolysis from CAA regs

Agency IQ

JUNE 9, 2023

The EPA first enacted NSPS and emissions guidelines for OSWI units on December 16, 2005. Under the 2005 regulations, and in all enacted regulations since that point, the agency has stated that “pyrolysis/combustion units” are within the ambit of OSWI.

Regulations

Regulations Packaging Treatment Production

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

Agency IQ

JUNE 16, 2023

This package would propose updates to the alternative work practice as appropriate based on the review and address the issues raised for reconsideration. Since promulgation, advancements have been made in leak detection technologies that warrant review of the alternative work practice. On September 14, 2018, the U.S.

Regulations

Regulations Compliance Production Science

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

Drug & Device Law

JULY 31, 2023

The 2005 revisions to Article 2 excludes “information” from the definition of goods and also defines computer software as “information.” Alaska 2005), predicted that Alaska would follow the Third Restatement “defin[ition] of a product as ‘tangible personal property distributed commercially for use or consumption.” Id. Munhoven v.

Production

Production International Trials Government

Unimpressed Learned Intermediaries Defeat Warning Causation

Drug & Device Law

MAY 30, 2022

1988) (no causation where prescriber “read the warning on the package insert and decided not to warn the [plaintiffs]”); Dunn v. 2005) (no causation where prescriber “testified that he selected. . . Accord Wyeth Laboratories, Inc. Fortenberry , 530 So.2d 2d 688, 691 (Miss. Lederle Laboratories , 328 N.W.2d 2d 576, 583-84 (Mich.

Testimonials

Testimonials Doctors Production Laboratories

Confident Learned Intermediaries Defeat Warning Causation

Drug & Device Law

JUNE 6, 2022

2000) (no causation where prescribing physician “testified that, had the packaging contained an extra warning as to [the plaintiff’s condition], he still would have prescribed it for the plaintiff”), aff’d , 21 F. even with the addition of the language now found in the package insert”); McDaniel v. 2005 WL 3440440, at *5-6 (D.N.J.

Testimonials

Testimonials Production Pharmaceuticals Drugs

Rounding Up the Eleventh Circuit Zombie

Drug & Device Law

MARCH 11, 2024

Section 136v(b) mandates that states may “not impose or continue in effect any requirements for labeling or packaging in addition to or different from those required under this subchapter” (emphasis added). 431 (2005). . §360k(a)) protecting medical devices − albeit limited to labeling. Dow Agrosciences LLC , 544 U.S. After PR v.

Regulations

Regulations Government Production Packaging

A Texas Mess

Drug & Device Law

JANUARY 4, 2024

The relevant legislative history demonstrates that Congress enacted the PREP Act in 2005: To encourage the expeditious development and deployment of medical countermeasures during a public health emergency. . . [by] 247d-6d(b)(8). “To Alabama State Board of Pharmacy , 61 F.4th 4th 902, 905 (11th Cir.

Vaccine

Vaccine FDA FDA Approval Production

Federal Officer Removal Fails In California

Drug & Device Law

JANUARY 25, 2024

308 (2005), which comes up not infrequently in drug and device product liability cases. The bottom line, however, is that the package of benefits that the MAO offers is up to the MAO. That is how plaintiff bought his medical walker and why we are talking about federal officer removal. Darue Eng’g & Mfg. ,

Production

Production Regulations FDA Compliance Compliance

California Federal Court Holds Onto Purported Class To Dismiss It Under The PREP Act

Drug & Device Law

MARCH 7, 2024

PREP, at least on these pages, generally refers to the sweeping immunity for COVID-19 counter-measures pursuant to the Public Readiness and Emergency Preparedness Act of 2005. packaging, marketing, promotion, [and] sale” of the drug would trigger immunity. Gilead Sciences, Inc. , 2:23-cv-2853 WBS DB, 2024 WL 732965 (E.D.

Hospitals

Hospitals FDA Packaging Virus

Drug Discovery Digest

Article Periodic Thank You European Commission unveils proposed ban on bisphenol A in food packaging

Analysis Chemical Thank You Explainer: carcinogen classification in the E.U., U.S., and internationally

Trending Sources

A Roadmap for Introducing Novel Excipients: How to Approach Excipient Qualification with the FDA

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Discovering an Antimalarial Drug in Mao’s China

Article FDA Thank You FDA updates set the stage for broader use of harmonized standards for safety reporting

Extraordinary General Meeting in Oncopeptides AB (publ) – Nov 03, 2020

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

Article Periodic Thank You EPA flips on Trump-era plan to exempt pyrolysis from CAA regs

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

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

Unimpressed Learned Intermediaries Defeat Warning Causation

Confident Learned Intermediaries Defeat Warning Causation

Rounding Up the Eleventh Circuit Zombie

A Texas Mess

Federal Officer Removal Fails In California

California Federal Court Holds Onto Purported Class To Dismiss It Under The PREP Act

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