2001, Packaging and Regulations - Drug Discovery Digest

Article EMA Thank You EMA publishes first electronic Product Information as pilot progresses

Agency IQ

NOVEMBER 20, 2023

readability of package leaflet, patient engagement). Summary of Product Characteristics and Package Leaflet), recommending that sponsors and regulators “explore the use of electronic media” to provide product information “in the future”. See also Article 11 of Directive 2001/83/EC.)

Production

Production Packaging Regulations Hospitals

Article FDA Thank You In a new final rule, FDA carves out a regulatory niche for medical gases

Agency IQ

JULY 8, 2024

In a new final rule, FDA carves out a regulatory niche for medical gases Industry has been lobbying FDA and Congress to regulate medical gases different from other types of drug products since the 1970s. It also proposed several packaging changes to safeguard against misidentification. The Medical Gas Safety Act , introduced by Rep.

FDA

FDA Regulations Production Packaging

Article EMA Thank You European Commission reveals action plan to address medicines shortages

Agency IQ

NOVEMBER 3, 2023

Currently, only Article 23a and Article 81 of Directive 2001/83/EC address medicines supply across the E.U. Regulation (EU) 2022/123 became applicable on March 1, 2022, with the exception of most provisions related to medical devices. See AgencyIQ’s analysis of the proposed regulation.] wide level.

Regulations

Regulations International Pharmaceuticals Production

Article EMA Thank You Commission proposes guidelines to flesh out the newly finalized Variations Regulation

Agency IQ

JUNE 21, 2024

Commission proposes guidelines to flesh out the newly finalized Variations Regulation This week, the newly finalized Variations Regulation was published in the Official Journal of the E.U. An updated guideline implementing the changes from the new regulation is now open for public consultation until August 23, 2024.

Regulations

Regulations Marketing Production Vaccine

Article EMA Thank You The devil is in the details: a deep dive into the state of Notified Body designations

Agency IQ

JUNE 7, 2024

The devil is in the details: a deep dive into the state of Notified Body designations While the European Commission has been laser-focused on the number of medical device and IVD certificates, AgencyIQ is taking a look at progress toward designating Notified Bodies to the European medical device and diagnostics regulations.

Regulations

Regulations Compliance Packaging Production

Article EMA Thank You New EC report dives deep to better understand shortages of critical medicines

Agency IQ

JULY 12, 2024

Regulation (EU) 2022/123 , which called for a “reinforced role for EMA in crisis preparedness and management for medicinal products and medical devices,” expanded EMA’s mandate to monitor and mitigate shortages at the E.U. active pharmaceutical ingredient, fill/finish, packaging/labeling). See AgencyIQ’s analysis of EMA’s milestones.]

Regulations

Regulations Packaging Production FDA

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

Article EMA Thank You New MHRA Windsor Framework documents guide post-Brexit flow of medicines for U.K., Great Britain, and the E.U.

Agency IQ

AUGUST 4, 2023

government was put in place on February 27, 2023 and includes a number of proposed regulations to address trade relations between the E.U. First: all medicines for Northern Ireland must be approved by the MHRA The new regulation (EU) 2023/1182 applies to medicines that require marketing authorization. and the U.K.

Packaging

Packaging Licensing Licensing Regulations

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

Where is the promise for plant-based medicines? Part 2: Psilocybin

Drug Discovery World

AUGUST 24, 2023

Of course, while the regulation remains a continuous battle, this does not hinder the research being undertaken. Business: Where is the money? When it comes to something as volatile and irregular in terms of regulation as psilocybin, funding is a key component if the field is to expand and progress.

Clinical Trials

Clinical Trials Treatment Regulations Trials

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

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

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 EMA Thank You The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation

Agency IQ

APRIL 12, 2024

The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation This week, the European Parliament voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. Directive 2001/83/EC and Regulation (EC) No 726/2004.

Pharmaceuticals

Pharmaceuticals Packaging Regulations Marketing

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

Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 2001); Isham v. 2001), relied on these other statutes to hold that a road could not be a “product”). 2001) (applying Illinois law); Serpico v. at 77 (citation omitted). In United States v. Brown , 348 F.3d

Production

Production International Trials Government

A Texas Mess

Drug & Device Law

JANUARY 4, 2024

341 (2001), and the exclusivity Buckman recognized of FDA authority over approval of the products it regulates also provide grounds for implied conflict preemption those the Complaint’s allegations. 247d-6d(b)(8). Plaintiffs Legal Committee , 531 U.S.

Vaccine

Vaccine FDA FDA Approval Pharmacy

Buckman Preempts Claims Despite State’s Adoption of the FDCA as State Law

Drug & Device Law

FEBRUARY 24, 2022

341 (2001), stands for the proposition that only the federal government may enforce the Food, Drug, and Cosmetic Act and that any state-law claim that depends on the existence of the FDCA is impliedly preempted by 21 U.S.C. § Plaintiffs’ Legal Committee , 531 U.S. Implicitly relying on 21 U.S.C. § 2022 WL 464149, at *1. 2022 WL 464149, at *4.

Packaging

Packaging Regulations FDA Government

FDCA Expressly Preempts State-Law Claim Challenging Labeling Statement Authorized By FDA Regulations

Drug & Device Law

MARCH 10, 2022

341 (2001), impliedly preempts claims based on California’s Sherman Act, which adopts the FDCA as state law. The court acknowledged that “[o]n one level, the plaintiffs may have a point,” because consumers will in fact digest less protein than indicated on the product packaging. A few weeks ago, we reported on Chong v.

Regulations

Regulations FDA Packaging FDA Approval

Drug Discovery Digest

Article EMA Thank You EMA publishes first electronic Product Information as pilot progresses

Article FDA Thank You In a new final rule, FDA carves out a regulatory niche for medical gases

Trending Sources

Article EMA Thank You European Commission reveals action plan to address medicines shortages

Article EMA Thank You Commission proposes guidelines to flesh out the newly finalized Variations Regulation

Article EMA Thank You The devil is in the details: a deep dive into the state of Notified Body designations

Article EMA Thank You New EC report dives deep to better understand shortages of critical medicines

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

Article EMA Thank You New MHRA Windsor Framework documents guide post-Brexit flow of medicines for U.K., Great Britain, and the E.U.

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

Where is the promise for plant-based medicines? Part 2: Psilocybin

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

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

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

Article EMA Thank You The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation

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

A Texas Mess

Buckman Preempts Claims Despite State’s Adoption of the FDCA as State Law

FDCA Expressly Preempts State-Law Claim Challenging Labeling Statement Authorized By FDA Regulations

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