Perficient: Drug Development

JULY 20, 2023

Further, your brand should engage in greener packaging solutions to conserve natural resources and maximize profits. Creating unified customer experiences across all touchpoints and channels is a common goal among retailers, and organizations often talk about being customer-centric and driving towards a personalized, consistent experience.

Production 52

Production Packaging Government 52

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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Regulations Clinical Trials Production Trials 40

Agency IQ

JULY 8, 2024

Title Type Comments Close Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration Under Section 564 Draft Guidance July 5 Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency Draft Guidance July 5 Financial Transparency and Efficiency of the Prescription (..)

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FDA Science Regulations Production 40

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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Packaging Regulations Production Compliance 40

KIF1A

APRIL 24, 2023

You will meet individuals, advocacy leaders, industry, and research experts who have been there and done it, over two days of in-person only panel discussions, hands-on workshops, and expert office hours.” RDDS 2023 focuses on collaboration – the foundation of success in rare disease research.

Packaging 52

Packaging Drug Development Therapies Research 52

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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FDA Science Regulations 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).

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FDA FDA Approval Production Regulations 40

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.,

Regulations 40

Regulations Production International Marketing 40

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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Regulations Production Packaging Science 40

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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FDA Disease Regulations Production 40

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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Regulations Production Compliance Pharmaceuticals 40

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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Regulations Clinical Trials Production Biosimilars 40

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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Regulations Production International Government 40

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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Treatment Trials Therapies Clinical Trials 40

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.

Treatment 52

Treatment Therapies FDA FDA Approval 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.]

Virus 40

Virus Science Production FDA 40

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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FDA Science Regulations Production 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

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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FDA Science Production Regulations 40

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.

Packaging 52

Packaging Production Vaccine International 52

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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Regulations Compliance Science Production 40

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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Regulations Production Compliance Science 40

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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Regulations Compliance Production Government 40

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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