2005, Marketing 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. 66 bans the placing of BPA on the market in thermal paper in concentrations equal to or greater than 0.02% by weight. eye damage, cat.

Packaging

Packaging Regulations Compliance Production

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

The Pharma Data

NOVEMBER 2, 2020

In preparation of the proposal, market practice in the US for peer companies has shown that the percentage for allocation to employees already employed normally amount to 10 to 150 per cent of the yearly Base salary, whereby the proposal in US Co-worker LTIP 2020 is that the allocation is limited to 10 to 100 per cent of the yearly Base Salary.

Marketing

Marketing Regulations Packaging Pharmaceutical Companies

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

Agency IQ

JANUARY 26, 2024

Samples retained for testing should be kept under similar storage conditions and within the same container-closure system in which the drug is marketed. In some cases, manufacturers have determined that specific drug products have limited stability when the original packaging is opened.

Science

Science FDA Packaging Production

Comment: Effective leadership and its effect on the drug discovery industry

Drug Discovery World

SEPTEMBER 29, 2022

Earlier this month, The Biden Administration announced plans for a $2 billion funding package for the biotechnology and manufacturing sector, to ensure a ‘sustainable, safe, and secure American bioeconomy’. Biden’s $2 billion biotech boost. billion over the period 2008–2020 2. Customer-focused leadership. UK-based H.E.L

Drugs

Drugs Clinical Trials Production Science

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

Agency IQ

APRIL 8, 2024

Since these issues could occur during the investigational phase of clinical development as well as in the post-marketing setting—and product status could very well differ by country/region—ICH members determined that these guidelines should be developed to facilitate the exchange of information in both settings.

FDA

FDA Production Regulations Vaccine

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. Delays In the early 1980s, eager to push artemisinin onto the international market, China turned to the World Health Organization (WHO).

Drugs

Drugs Science Research Doctors

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

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 Highlights of the EPA’s Unified Agenda for Spring 2023

Agency IQ

JUNE 16, 2023

For increased flexibility in bringing PIPs to market, a developer can also submit both. Market-based mechanisms include water quality trading under the Clean Water Act (CWA), an approach that may cost less than more traditional regulatory approaches. EPA is reviewing the comments received and is planning to issue a final rule.

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.” no[r] a marketing product” under Lanham Act). City of Madera , 2005 WL 1683736, at *13 (E.D. July 11, 2005), aff’d , 277 F. Leading Market Technologies, Inc. , Paragon 28, Inc.

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. In In re Plavix Marketing, Sales Practices & Products Liability Litigation , 2017 WL 4838842 at *6-7 (D.N.J. 2005) (no causation where prescriber “testified that he selected. . . 2d 688, 691 (Miss.

Testimonials

Testimonials Doctors Production Laboratories

Confident Learned Intermediaries Defeat Warning Causation

Drug & Device Law

JUNE 6, 2022

26, 2015); In re Plavix Product & Marketing Cases , 2017 WL 2882212, at *3 (Cal. 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. District of Columbia. Mason , 27 So.3d

Testimonials

Testimonials Production Pharmaceuticals Treatment

A Texas Mess

Drug & Device Law

JANUARY 4, 2024

purchase, marketing, promotion, . . 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). Strike two. The suit “relates to” – at least – “the. . . Strike three.

Vaccine

Vaccine FDA FDA Approval Pharmacy

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 Packaging FDA Virus

Drug Discovery Digest

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

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

Trending Sources

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

Comment: Effective leadership and its effect on the drug discovery industry

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

Discovering an Antimalarial Drug in Mao’s China

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

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

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

A Texas Mess

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

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