Agency IQ

MARCH 1, 2024

What we expect EU regulators to do in March 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. ECHA will hold two webinars, the first introducing the agency’s guidance on assessing biocide risks to bees, and the second providing insight into the OECD QSAR assessment framework in REACH’s dossier evaluation procedure.

Regulations 40

Regulations Production Packaging Science 40

Agency IQ

SEPTEMBER 15, 2023

PFAS regulation in California (late 2023 edition) California consistently maintains its status as both one of the most important economies in the world as well as one of the most regulated states in the United States. In 2019, the state began to significantly ramp up its PFAS regulation and research.

Regulations 40

Regulations Packaging Production Organic Chemistry 40

Agency IQ

AUGUST 2, 2024

What we expect EU chemical regulators to do in August 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Other consultations ending in August include two addressing potential candidates for substitution and exemption conditions under the Biocidal Products Regulation (BPR), including for the substance DBNPA.

Regulations 40

Regulations Production Packaging International 40

Agency IQ

AUGUST 30, 2024

What we expect EU chemical regulators to do in September 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. A full list of chemical events is also scheduled for September, as regulators and regulatory affairs professionals return to work after the summer holidays.

Regulations 40

Regulations Production Government Packaging 40

Agency IQ

JANUARY 4, 2024

What we expect EU regulators to do in January 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. The Commission may be close to delivering this proposal , given that the EU executive recently adopted a package of related draft legislation in support of the CSS’s one substance-one assessment (1S1A) ambition.

Regulations 40

Regulations Packaging Production Government 40

Agency IQ

OCTOBER 27, 2023

What we expect EU regulators to do in November 2023 Welcome to AgencyIQ’s roundup of upcoming regulatory activities in the EU chemicals sector. Regulation on detergents and surfactants The expert working group on detergents is scheduled to hold a meeting on November 17.

Regulations 40

Regulations Production Packaging International 40

Agency IQ

FEBRUARY 2, 2024

What we expect EU regulators to do in February 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. BY SCOTT STEPHENS, MPA | JAN 26, 2024 10:22 PM CST Highlights of upcoming chemical regulatory activities Consultations under the REACH and CLP regulations are coming to an end in February.

Regulations 40

Regulations Production Government Marketing 40

Agency IQ

DECEMBER 1, 2023

What we expect EU regulators to do in December 2023 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Highlights of chemical regulatory activities Consultations open under the REACH and CLP regulations are coming to an end in December. Events happening next month include two ECHA meetings (i.e.,

Regulations 40

Regulations Production International Marketing 40

Advarra

JULY 19, 2022

Advarra experts Sharon Ayd and Leslie Paul answer questions from their webinar, The IND Journey Phase I – Navigating Success. The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. A: Yes, the EUA is just temporary. Yes, each drug has its own requirements.

Packaging 52

Packaging FDA Trials Regulations 52

Agency IQ

FEBRUARY 23, 2024

Background: PFAS regulation in California PFAS have been the subject of significant regulations in California, beginning in the 2010s [for an in-depth review of PFAS regulation in California, see the AgencyIQ analysis here ]. In 2019, the state began to significantly ramp up its PFAS regulation and research.

Packaging 40

Packaging Regulations Production Compliance 40

Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Clinical Trials 40

Agency IQ

SEPTEMBER 29, 2023

agencies and institutions to deliver insight into what chemicals-related regulatory actions are likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more. Proposal for a regulation Initiative entry Chemicals – making best use of E.U. CLP revision. It will also enable E.U.

Regulations 40

Regulations Packaging Production International 40

Drug Target Review

DECEMBER 5, 2024

2 However, utilisation of biological systems introduces variability and by-products, as well as a challenge unique to AAV production: the assembly of full capsids with correctly packaged DNA, partially filled capsids containing partial vector and/or host cell DNA, and empty capsids. References Pratt CB, Alsarraj MA. Labcompare.

Therapies 52

Therapies Virus DNA Compliance 52

Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Production 40

Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Biosimilars 40

Agency IQ

APRIL 12, 2024

The regulations also explain that this trait can be demonstrated via appropriate laboratory tests or adequately controlled clinical data. In an effort to further explain its current views on potency assurance, the FDA also recorded a webinar to accompany the new draft.

Production 40

Production FDA Therapies Biochemical Assays 40

Agency IQ

AUGUST 23, 2024

By Laura DiAngelo, MPH | Aug 22, 2024 10:13 PM CDT Intro: Pre-Determined Change Control Plans in medical device regulation Post-market updates to authorized medical devices may, or may not, require a new submission to the FDA. In late 2022, the FDA gained new authority related to PCCPs.

Science 40

Science FDA Marketing Production 40

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 40

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.

Regulations 40

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

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 40

Regulations Compliance Science Production 40

Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Prohaska, Kavita C.

FDA 40

FDA Science Regulations Production 40

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.

Regulations 40

Regulations Compliance Government Science 40