2007, Packaging and Regulations - Drug Discovery Digest

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 Regulations Packaging Marketing

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

Analysis Life Sciences Thank You After 13-year review, FDA finalizes ‘clear, conspicuous and neutral’ drug advertising rule

Agency IQ

NOVEMBER 27, 2023

The regulations also provided clarification regarding what does not constitute a “true statement,” including false or misleading information, failure to reveal important facts, and/or the lack of a fair balance between side effects/contraindications and effectiveness.

FDA

FDA Science Drugs Regulations

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

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Second Phase 3 Induction Study Confirms Upadacitinib (RINVOQ™) Improved Clinical, Endoscopic and Histologic Outcomes in Ulcerative Colitis Patients

The Pharma Data

FEBRUARY 22, 2021

RINVOQ (upadacitinib) [Package Insert]. ClinicalTrials.gov. Available at: [link]. Accessed on February 12, 2021. The Economic Costs of Crohn’s Disease and Ulcerative Colitis. Access Economics Pty Limited. Available at: [link]. Accessed on February 12, 2021. The Facts about Inflammatory Bowel Diseases. Available at: [link].

Disease

Disease Treatment Therapies Trials

AbbVie Presents New Late-Breaking Data Analyses Showing Risankizumab (SKYRIZI®) Achieves Clinical Remission and Endoscopic Response at Week 12 in Patients with Moderate to Severe Crohn’s Disease

The Pharma Data

JUNE 18, 2021

SYRIZI (risankizumab) [Package Insert]. Symptoms and Causes. Mayo Clinic. Available at: [link]. Accessed on April 9, 2021. The Economic Cost of Crohn’s Disease and Ulcerative Colitis. Access Economics Pty Limited. Available at: [link]. Accessed April 9, 2021. The global burden of IBD: from 2015 to 2025. Nat Rev Gastroenterol Hepatol.

Disease

Disease Therapies Treatment Clinical Trials

Phase 3 Maintenance Results Show Patients with Crohn’s Disease Receiving Risankizumab (SKYRIZI®) Achieved Endoscopic Response and Clinical Remission at One Year

The Pharma Data

JUNE 18, 2021

SKYRIZI (risankizumab) [Package Insert]. The Economic Costs of Crohn’s Disease and Ulcerative Colitis. Access Economics Pty Limited. Available at: [link]. Accessed on May 21, 2021. Duvallet, E., Sererano, L., Assier, E., Interleukin-23: a key cytokine in inflammatory diseases. 2011 Nov;43(7):503-11. North Chicago, Ill. AbbVie Inc. .

Disease

Disease Treatment Therapies Trials

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 Life Sciences Thank You Congress’ asks for FDA in the budget bill: Diagnostics, drug importation, vouchers and EtO updates

Agency IQ

MARCH 7, 2024

BY LAURA DIANGELO, MPH | MAR 6, 2024 5:54 PM CST Fiscal year 2024 appropriations bills On March 3, 2024, House and Senate appropriators released a package of final fiscal year (FY) 2024 appropriations bills. AgencyIQ has the highlights. As POLITICO reported , this generally represents a 5.2% This is already raising some red flags.

FDA

FDA Packaging Science Drugs

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

The Battle for Better Air

Codon

FEBRUARY 2, 2025

Opening windows is a simple and effective way to regulate indoor air quality by reducing particulate matter, the buildup of viruses and CO₂, and (aesthetically) bad smells. In 1965, Congress mandated labeling on all cigarette packaging that warned consumers about the risks of smoking.

Disease

Disease Vaccine Nurses Engineering

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

Barcoding Brains

Codon

FEBRUARY 9, 2025

The connection between the destroyed lobe and Gage’s reduced capacity for emotional regulation was stark. To achieve this, E11 Bio synthesizes protein barcodes (short peptides with unique amino acid sequences), packages them into AAV vectors (engineered, non-harmful viruses for drug delivery), and delivers these into the brain tissue.

Research

Research Disease Engineering Regulations

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. The bottom line, however, is that the package of benefits that the MAO offers is up to the MAO. Philip Morris Cos. ,

Production

Production Regulations FDA Compliance Compliance

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. 2007 WL 2460776, at *6 (D. 2007 WL 218242, at *4 (N.D. 26, 2007) (bespoke software not a UCC good). 2007), held that “defective computer software may give rise to strict products liability in tort.”

Production

Production Trials International Government

Drug Discovery Digest

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

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

Webinars

Trending Sources

Analysis Life Sciences Thank You After 13-year review, FDA finalizes ‘clear, conspicuous and neutral’ drug advertising rule

Webinars

Second Phase 3 Induction Study Confirms Upadacitinib (RINVOQ™) Improved Clinical, Endoscopic and Histologic Outcomes in Ulcerative Colitis Patients

AbbVie Presents New Late-Breaking Data Analyses Showing Risankizumab (SKYRIZI®) Achieves Clinical Remission and Endoscopic Response at Week 12 in Patients with Moderate to Severe Crohn’s Disease

Phase 3 Maintenance Results Show Patients with Crohn’s Disease Receiving Risankizumab (SKYRIZI®) Achieved Endoscopic Response and Clinical Remission at One Year

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 Life Sciences Thank You Congress’ asks for FDA in the budget bill: Diagnostics, drug importation, vouchers and EtO updates

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

The Battle for Better Air

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

Barcoding Brains

Federal Officer Removal Fails In California

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

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