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.

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Regulations Compliance Packaging Production 40

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.

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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.

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FDA Science Drugs Regulations 40

LifeSciVC

APRIL 27, 2023

Much of our success springs from being nimble and pragmatic on the journey: by optimizing areas we know work well and adapting to ever-changing landscapes in the capital markets, therapeutics spaces, and laws and regulations (e.g., Chapter 1 – An Unreasonable Idea The year was 2009.

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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.

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Regulations Compliance Production Government 40

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.

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Regulations Compliance Production Government 40

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 40

Regulations Production Compliance Science 40

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 40

Regulations Compliance Production Science 40

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.

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Regulations Compliance Science Production 40

Codon

MARCH 14, 2023

In 2009, a small group of Dutch biologists rounded up some lab mice, stabbed them with needles, and harvested their blood. There are even differences in how their genomic DNA is packaged inside of neurons. ” About 6% of all mouse genes are regulated in sex-specific ways. Nobody really knows why.

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DNA Laboratories Engineering Animal Testing 52

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.

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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 40

Regulations Compliance Engineering Government 40

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.

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Regulations Compliance Government Science 40

Agency IQ

JULY 28, 2023

October 1, 2023 [link] Regulations Expected to be Published in Q3These are taken from the most recent version of the White House’s Unified Agenda. Specifically, this ANPRM seeks comments, research, information, data, and responses from certain categories of stakeholders that can inform the Agency’s modernization of FDA’s recall regulation.

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FDA Science Biosimilars Regulations 40

Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 2009 WL 1142570, at *8 (Conn. April 1, 2009) (contract to revise and encrypt plaintiff’s existing software did not involve a UCC good); Bobryk v. 2009); see also Data Processing Services, Inc. Brown , 348 F.3d

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Production International Trials Government 52

Drug & Device Law

MAY 4, 2023

Here, because there was already pertinent risk information in the “Warnings and Precautions” section of the Full Prescribing Information portion of the label, FDA regulations required that any proposed change be done through a prior approval supplement because the “Highlights” section would also need to change. App’x 994, 995 (6th Cir.

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Drug & Device Law

DECEMBER 19, 2022

2019), it simply misconstrued the FDA’s rather (that’s an understatement) complicated supplemental application/changes being effected regulation, 21 C.F.R. Sub-sub-sub-subsection (C) references the “highlights” part of the FDA’s general drug labeling regulation, 21 C.F.R. 555 (2009), relied upon to limit impossibility preemption. (B)

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Drug & Device Law

SEPTEMBER 12, 2022

The case alleged on-label drug use between 2009 and early 2012, purportedly leading to plaintiffs’ decedent’s suicide in 2013 – more than a year after use of the drug had ceased. Preemption turns on the availability of the FDA’s changes being accepted (“CBE”) regulation, 21 C.F.R. 12 (citation and quotation marks omitted).

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FDA FDA Approval Regulations International 59

Drug & Device Law

FEBRUARY 24, 2022

Because § 343-1(a) applies only to foods, the court’s detailed analysis of the relevant labeling regulations is not directly applicable to drug and device cases. That evasive maneuver fails because such a claim “would not exist if the FDCA did not exist” and “is in substance (even if not in form) a claim for violating the FDCA.” Precisely so.

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Packaging Regulations FDA Government 72