2005, Packaging and Regulations - Drug Discovery Digest

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

Agency IQ

AUGUST 18, 2023

and internationally Establishing and communicating a substance’s potential to cause cancer is a cornerstone of chemical regulation worldwide. Many entries in category 2B are only weakly associated with carcinogenicity and are generally unlikely to be regulated for causing cancer. For more on the regulation of glyphosate in the E.U.,

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

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. B1) BPA’s regulation across so many sectors affecting different parts of the supply chain (i.e., eye damage, cat.

Packaging

Packaging Regulations Compliance Production

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

Agency IQ

JANUARY 26, 2024

Though regulations guide some aspects of how expiration dates are determined, the agency has but limited power to extend those dates unilaterally. As part of current good manufacturing practice (cGMP) regulations, drugs are required to bear an expiration date determined by “appropriate stability testing,” according to 21 CFR 211.137.

Science

Science FDA Packaging Production

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

Agency IQ

DECEMBER 15, 2023

The 174 regulations the EPA is currently working on The Environmental Protection Agency has unveiled its Fall 2023 Unified Agenda, which provides a look into the agency’s regulatory agenda for the upcoming year. The expected release dates of the agendas rarely line up exactly with the actual dates when the agency releases the regulation.

Regulations

Regulations Compliance Production Government

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

Agency IQ

MARCH 29, 2024

What we expect the EPA to do in April 2024 The top line: In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. PFAS regulations for drinking water.

Regulations

Regulations Compliance Production Government

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

Agency IQ

APRIL 8, 2024

FDA updates set the stage for broader use of harmonized standards for safety reporting Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. Periodic Benefit-Risk Evaluation Reports ).

FDA

FDA Production Regulations Vaccine

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

The Pharma Data

NOVEMBER 2, 2020

To this end, the Board of Directors shall be entitled to make adjustments to meet foreign regulations or market conditions, including resolving on cash or other settlement if deemed favorable for Oncopeptides based on foreign tax regulations.

Marketing

Marketing Regulations Packaging Pharmaceutical Companies

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

Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. This information would be used in considering the regulation of asbestos.

Regulations

Regulations Compliance Production Science

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

Agency IQ

JUNE 9, 2023

These regulations apply to new sources of emissions in the industry (under the NSPS) as well as procedures for states to submit plans for implementing emissions guidelines for existing sources of emissions. The EPA first enacted NSPS and emissions guidelines for OSWI units on December 16, 2005.

Regulations

Regulations Packaging Production Treatment

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.” 2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. City of Madera , 2005 WL 1683736, at *13 (E.D. July 11, 2005), aff’d , 277 F.

Production

Production International Trials Government

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. Plaintiffs Legal Committee , 531 U.S.

Vaccine

Vaccine FDA FDA Approval Pharmacy

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). 4th at 991, even though the relevant federal regulator (the EPA) did not require any such warning.

Regulations

Regulations Government Production Packaging

Federal Officer Removal Fails In California

Drug & Device Law

JANUARY 25, 2024

142 (2007), mere regulation of the product or conduct at issue—the medical walker is a non-prescription, Class I medical device with general controls only—is not a basis for removal under this statute. 308 (2005), which comes up not infrequently in drug and device product liability cases. Since the Supreme Court decision in Watson v.

Production

Production Regulations FDA Compliance Compliance

Drug Discovery Digest

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

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

Trending Sources

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

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

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 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 Highlights of the EPA’s Unified Agenda for Spring 2023

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

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

A Texas Mess

Rounding Up the Eleventh Circuit Zombie

Federal Officer Removal Fails In California

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