2003, Packaging and Regulations - Drug Discovery Digest

Transitioning to eCTD v4.0

The Premier Consulting Blog

APRIL 27, 2023

In 2003, the original eCTD was adopted by health authorities and sponsors both in the U.S. Sponsors should prepare by reviewing implementation packages from the ICH and applicable regions. Implementation Package v1.5 Implementation Package v1.5 Module 1 Implementation Package FDA eCTD v4.0 How can you prepare?

Packaging

Packaging FDA International Pharmaceuticals

The Economics of Investigational Device Exemption (IDE) Studies: What You Need to Know About Medicare Coverage

The Premier Consulting Blog

DECEMBER 28, 2023

This article reviews the regulations governing charging or obtaining insurance coverage for an investigational device. CMS has created a checklist to assist sponsors in submitting a complete package. 2] Code of Federal Regulations. 3] Code of Federal Regulations. Resources [1] US Food and Drug Administration.

Regulations

Regulations FDA Clinical Trials Packaging

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

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

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Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Agency IQ

JUNE 2, 2023

Within the realm of FDA-required labeling, there are currently a few different types of information a sponsor might develop specifically for patient use: medication guides, instructions for use (IFU), consumer medical information (CMI) and patient package inserts (PPI). The FDA recently concluded its work on a proposed rule focused on PMI.

FDA

FDA FDA Approval Production Regulations

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 December 2023

Agency IQ

DECEMBER 1, 2023

What we expect the EPA to do in December 2023 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations

Regulations Production Science Compliance

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

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

Agency IQ

OCTOBER 27, 2023

What we expect the EPA to do in November 2023 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency (EPA) is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. TSCA risk management rules.

Regulations

Regulations Compliance Science 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

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

Agency IQ

FEBRUARY 2, 2024

What we expect the EPA to do in February In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. The Agency expects to issue a final rule later in 2023.

Regulations

Regulations Compliance Engineering Government

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

Agency IQ

JANUARY 4, 2024

What we expect the EPA to do in January 2024 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations

Regulations Government Compliance Science

Levers for Biological Progress

Codon

NOVEMBER 1, 2024

A first draft was published in 2003; it was a patchwork of sequenced DNA from multiple people. They engineered genetically-encoded RNA exporters, based on viruses, that package and secrete RNA molecules in protective nanoparticles, allowing non-destructive monitoring of those RNA molecules in real-time.

DNA

DNA RNA Molecular Biology Laboratories

A Texas Mess

Drug & Device Law

JANUARY 4, 2024

2003); Birdsong v. 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. See Henry Schein, Inc. Stromboe , 102 S.W.3d 3d 675, 698 (Tex. 2002); Tracker Marine, L.P. Ogle , 108 S.W.3d

Vaccine

Vaccine FDA FDA Approval Production

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. 23, 37 (2003) (“the phrase refers to the producer of the tangible goods that are offered for sale, and not to the author of any idea, concept, or communication embodied in those goods”). 2003), review denied (Cal.

Production

Production Trials International Government

Drug Discovery Digest

Transitioning to eCTD v4.0

The Economics of Investigational Device Exemption (IDE) Studies: What You Need to Know About Medicare Coverage

Webinars

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

Webinars

Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

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 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 November 2023

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 February

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

Levers for Biological Progress

A Texas Mess

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

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