Agency IQ

FEBRUARY 23, 2024

In the same month, the California Department of Toxic Substances Control (DTSC) presented its chemical profile for carpets and rugs containing PFAS as well as a webinar for its findings on PFAS in food packaging.

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Agency IQ

DECEMBER 1, 2023

for the member state and socio-economic analysis committees), a meeting of the REACH Committee, and a safe-and-sustainable-by-design (SSbD) workshop hosted by the Joint Research Centre (JRC), among others. food packaging, kitchen and tableware and food processing equipment). Events happening next month include two ECHA meetings (i.e.,

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Agency IQ

JUNE 26, 2023

Marks explained that he feels the greatest opportunity to benefit the development of therapies for rare diseases lies in alignment between regulatory authorities on submission requirements for these applications, to enable standardized review packages and concurrent submission and review of product applications.

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Agency IQ

MARCH 1, 2024

food packaging, kitchen and tableware and food processing equipment). Proposal for Regulation Initiative entry Revision of EU rules on food contact materials Adoption was planned for second quarter of 2023 This initiative will likely be postponed until the next Commission after June 2024.

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Agency IQ

MAY 3, 2024

The pharma reform package remains in E.U. In the interim, the European Council will continue to discuss the package, and stakeholders may gain some insight into the Council’s thinking near the end of May. leaders’ eyesight as the Parliament winds down ahead of its June elections. On April 10, the E.U. On April 10, the E.U.

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Agency IQ

AUGUST 11, 2023

EMA’s investigation ended up revealing even more causes of nitrosamine impurities in drugs, discovering, for example , that formation happened during the heat-sealing process of in certain products using blister-packaging. Two workshops co-hosted by the FDA this summer addressed nitrosamines in general, and the NDSRI question in particular.

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Agency IQ

MAY 31, 2024

food packaging, kitchen and tableware and food processing equipment). regulation, directive, decision). Proposal for Regulation Initiative entry Revision of EU rules on food contact materials Adoption was planned for Q2 2023 This initiative will likely be postponed until the next Commission after June 2024.

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Agency IQ

OCTOBER 27, 2023

Title Type Comments Close Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief Guidance November 1 Post-Warning Letter Meetings Under GDUFA Guidance November 6 In-Home (..)

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Agency IQ

OCTOBER 27, 2023

A wide range of other meetings that will be occurring this month, with various webinars, committee meetings, and workshops spanning a variety of topics. Many of these are open to any interested listener. Upcoming E.U.

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Agency IQ

AUGUST 2, 2024

Another legislative area that will also likely receive more attention will be the pharma reform package , since the two Parliament rapporteurs to lead the package negotiations were recently appointed.

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Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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The Pharma Data

JUNE 26, 2021

A full program of bootcamps, hack-a-thons, and design thinking workshops led by Sanofi’s Innovation Lab helped the teams turn their ideas into sustainable projects. Three winning projects were selected this inaugural year. More on Sanofi’s environmental management and achievements: [link].

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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).

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Agency IQ

MAY 31, 2024

Even small changes in the Parliament’s composition could have an impact on ongoing legislative discussions, such as the revisions to the pharma reform package. The current European Parliament and Commission have confirmed their position on the pharma package, but the European Council is still working on its negotiation position.

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Agency IQ

JULY 28, 2023

September 30, 2023 PDUFA Sentinel: Pregnancy Hold a public workshop on post-market safety studies in pregnant women to facilitate determination of the ideal post-market study design(s), including industry experience and use of Sentinel Initiative and other real-world data resources. But despite the law’s age, it is not yet fully operational.

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FDA Science Biosimilars Regulations 40

Codon

JUNE 26, 2023

For context, the AAV9 that is often used in gene therapies has a packaging limit of 4,700 DNA bases.) A writing workshop was followed by pizza and rosé Thanks to everyone who showed up. A T4 phage can hold 171,000 bases of DNA or other molecules, including proteins and RNA. They’re incredibly versatile. Paper by Sha G.

DNA 52

DNA Therapies Engineering Clinical Trials 52

Codon

JUNE 26, 2023

For context, the AAV9 that is often used in gene therapies has a packaging limit of 4,700 DNA bases.) A writing workshop was followed by pizza and rosé Thanks to everyone who showed up. A T4 phage can hold 171,000 bases of DNA or other molecules, including proteins and RNA. They’re incredibly versatile. Paper by Sha G.

DNA 52

DNA Therapies Engineering Clinical Trials 52

Agency IQ

JANUARY 19, 2024

a recombinant protein or gene therapy packaged via AAV virus) which has been produced by the cells, in addition to other debris such as the remaining media and the remnants of the cells. For more background, read AgencyIQ’s analysis of a recent workshop where FDA sought input on the building blocks for platform technology designation.]

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Agency IQ

DECEMBER 1, 2023

Title Type Date Cleared by OIRA Legal Deadline None Notable FDA Comment Periods Closing in December and January FDA comment periods are typically open for 30-60 days, unless they are extended. The content will include both goals for enrollment of populations and rationales for those goals.

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The Pharma Data

MAY 14, 2021

Never before have they been available to the public all together, in one special “master package” such as what you’re about to get your hands on here and now. Until now, he’s only “released” some of these secrets in dribs-and-drabs to some of his more trusted students. Anyway, I could go on and on.

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Packaging Production Vaccine International 52

The Pharma Data

JUNE 18, 2021

The trial enrolled 432 patients, all of whom were previously untreated according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria. 7 VENCLEXTA (venetoclax) [Package Insert]. Efficacy was based on PFS as assessed by an independent review committee. Accessed January 2020. 6 World Health Organization.

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Agency IQ

DECEMBER 1, 2023

This package would propose updates to the alternative work practice as appropriate based on the review and address the issues raised for reconsideration. Since promulgation, advancements have been made in leak detection technologies that warrant review of the alternative work practice.

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Agency IQ

OCTOBER 27, 2023

The supplemental proposal narrowed certain proposed exemptions for entities subject to the EPA-initiated risk evaluation fees and proposed exemptions for the test rule fee activities; proposed modifications to the self-identification and reporting requirements for EPA-initiated risk evaluation and test rule fees; proposed a partial refund of fees for (..)

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The Pharma Data

JUNE 18, 2021

65 years or 18-64 years with cumulative illness rating scale score >6 or creatinine clearance <70 mL/min who had active disease requiring treatment per the International Workshop on CLL (iwCLL) criteria. 8 VENCLEXTA (venetoclax) [Package Insert].?North?Chicago, Patients with del(17p) or known TP53 mutations were excluded.

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Perficient: Drug Development

DECEMBER 3, 2024

Imagine you’re stepping into a magical workshop where Salesforce developers wield a powerful tool called Apex. If a managed package is involved, the version ensures compatibility with that package—even if the package gets updated later. The language brings Salesforce to life—like an artist’s brush on a blank canvas.

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FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

CBERs approach here was to take FAQs from across sponsor interactions, public workshops, email requests, etc. The draft guidance recommends that no more than 15 questions are included in the briefing package. CBER will not commit to reviewing packages greater than 250 pages.

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Perficient: Drug Development

MARCH 8, 2025

This transformation might involve establishing paid consulting opportunities for community experts, creating accessible design workshops in underserved neighborhoods, or forming equitable partnerships where decision-making authority is genuinely shared.

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Agency IQ

DECEMBER 15, 2023

For this routine MUR, EPA will only consider new methods or method revisions for which a complete, acceptable method package has been received by January 7, 2022. This package would propose updates to the alternative work practice as appropriate based on the review and address the issues raised for reconsideration.

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