2006, Drugs, Packaging and Regulations

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.

FDA

FDA Regulations Production Packaging

Drug labeling authority, UDI program reviewed by Harvard-based researchers

The Pharma Data

MAY 17, 2021

The authority to change drug labels outside of considerations for new safety information “could encourage third parties, such as academic investigators, insurance companies, and cooperative trial groups, to initiate such changes,” they wrote. .

Research

Research FDA Approval Packaging FDA

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

The Lancet Publishes Results from Pivotal Global Phase 3 Program Evaluating RINVOQ® (upadacitinib) in Atopic Dermatitis

The Pharma Data

JUNE 18, 2021

You are encouraged to report negative side effects of prescription drugs to the FDA. 2017;34(8):1989–2006. RINVOQ ® (upadacitinib) [Package Insert]. Take RINVOQ exactly as your HCP tells you to use it. This is the most important information to know about RINVOQ. For more information, talk to your HCP. Shrestha S., Upadacitinib.

Treatment

Treatment Disease FDA Vaccine

Article Periodic Thank You California set to ban an additional 26 chemicals from cosmetics

Agency IQ

SEPTEMBER 15, 2023

SEP 11, 2023 10:49 PM CDT Regulatory background Cosmetic ingredients in California are governed by the Federal Food, Drug & Cosmetic Act (FD&C Act), which provides that cosmetics produced or distributed for retail sale to consumers for their personal care are required to bear an ingredient declaration ( 21 CFR 701.3 ). Chapter 54.

Regulations

Regulations Packaging Production Government

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 Overview of the U.S. regulation of PFAS

Agency IQ

OCTOBER 20, 2023

In the United States, the Environmental Protection Agency (EPA) has developed a PFAS Roadmap and proposed numerous regulations for managing the effects PFAS has on the environment and human health. carpets, fabrics, and food packaging) and in specialty chemicals (i.e. BY PATRICIA ISCARO, ESQ. | OCT 11, 2023 7:05 PM CDT What are PFAS?

Regulations

Regulations Production Packaging Treatment

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 Life Sciences Thank You The 53 regulations that FDA is currently working on

Agency IQ

JULY 12, 2024

The 53 regulations that FDA is currently working on The FDA on Friday unveiled its much-anticipated Spring 2024 Unified Agenda, a document outlining the regulations the agency plans to release in 2024 and beyond. Of those 53, seven are new to the Agenda, having never before been included in prior agendas.

Regulations

Regulations FDA Science Production

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 Production

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

Agency IQ

JULY 28, 2023

DSCSA implementation – Down to the wire as a deadline draws near: The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 as part of the Drug Quality and Security Act (DQSA), following several drug counterfeiting scandals in which falsified medical products entered the supply chain.

FDA

FDA Science Biosimilars Regulations

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. 2006 WL 2595944, at *23 (N.D. 11, 2006) (same), aff’d in pertinent part , 291 F. 2006) (video game “clearly qualifies as an ‘artistic work’ entitled to First Amendment protection”). 2006), aff’d , 279 F.

Production

Production International Trials Government

Pretty Potent Mix In A Prescription Painkiller Preemption Decision

Drug & Device Law

MAY 4, 2023

In the show position might be that the temporal relationship between a new medical condition and the use of a drug or medical device does not, without more, prove causation. 2015), finally gave appellate recognition to the preemption of design defect claims for FDA-approved branded prescription drugs. Ortho-McNeil-Janssen Pharms.,

FDA Approval

FDA Approval FDA Regulations Production

Drug Discovery Digest

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

Drug labeling authority, UDI program reviewed by Harvard-based researchers

Trending Sources

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

The Lancet Publishes Results from Pivotal Global Phase 3 Program Evaluating RINVOQ® (upadacitinib) in Atopic Dermatitis

Article Periodic Thank You California set to ban an additional 26 chemicals from cosmetics

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 Overview of the U.S. regulation of PFAS

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

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

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

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

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

Pretty Potent Mix In A Prescription Painkiller Preemption Decision

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