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).

Regulations 40

Regulations Production International Marketing 40

Agency IQ

JUNE 26, 2023

Last month at a cell and gene therapy conference fireside chat, FDA Center for Biologics Evaluation and Research (CBER) director Peter Marks rearticulated this vision [ See AgencyIQ’s analyses of February Rare Disease Day Event and an April Alliance for a Stronger FDA event for more on this topic.

FDA 40

FDA Disease Regulations Production 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.

Regulations 40

Regulations Production Packaging Science 40

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. In a study of more than 12,000 small molecule drugs , researchers found 40.4%

FDA 40

FDA Science Production Regulations 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.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

Agency IQ

MAY 31, 2024

The agency will host two free webinars, one addressing preparation for the upcoming chromium VI restriction (June 6) and the second covering research needs for protecting human health and the environment (June 18). food packaging, kitchen and tableware and food processing equipment). regulation, directive, decision).

Regulations 40

Regulations Production International Government 40

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 (..)

FDA 40

FDA Science Regulations Production 40

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.

Regulations 40

Regulations Pharmaceuticals Production Packaging 40

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 (..)

FDA 40

FDA Science Regulations Clinical Trials 40

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.

Regulations 40

Regulations Clinical Trials Production Trials 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).

FDA 40

FDA FDA Approval Production Regulations 40

Agency IQ

JULY 28, 2023

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. The workshop will solicit and include industry and public feedback. But despite the law’s age, it is not yet fully operational.

FDA 40

FDA Science Biosimilars Regulations 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.

Regulations 40

Regulations Production Compliance Pharmaceuticals 40

Codon

JUNE 26, 2023

Goodsell, Scripps Research and RCSB Protein Data Bank. And for another study, researchers engineered bacteriophage T4 to target and deliver payloads to human cells , simply by swapping around the proteins on their outer shells and then coating them in positively-charged lipid molecules. “Every query is like $2.”

DNA 52

DNA Therapies Engineering Clinical Trials 52

Codon

JUNE 26, 2023

Goodsell, Scripps Research and RCSB Protein Data Bank. And for another study, researchers engineered bacteriophage T4 to target and deliver payloads to human cells , simply by swapping around the proteins on their outer shells and then coating them in positively-charged lipid molecules. “Every query is like $2.”

DNA 52

DNA Therapies Engineering Clinical Trials 52

Agency IQ

JANUARY 19, 2024

While some biologic developers may choose to develop new cell lines in-house, given the extensive resources required to do so, it is common for researchers and/or sponsors to acquire cell seeds from outside laboratories or cell banks. the recombinant protein). This bulk product contains both the final product (e.g.,

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 report will also cover Federal agency roles in addressing vulnerabilities and statutory limitations.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

MAY 14, 2021

These Forbidden Fitness Secrets of A Modern Day Ninja Warrior are the result several decades of obsessive training and research. 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. Anyway, that’s NOT what this is about.

Packaging 52

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. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood and other cancers. and by AbbVie outside of the U.S.

Treatment 40

Treatment Trials Therapies Clinical Trials 40

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 (..)

Regulations 40

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.

Regulations 40

Regulations Production Science Compliance 40

The Pharma Data

JUNE 18, 2021

“With CLL being one of the most common types of blood cancer, the expansion of research into additional treatment options for patients is an important clinical undertaking,” said Arnon Kater , M.D., Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood cancers.

Treatment 52

Treatment Therapies FDA FDA Approval 52

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.

Compliance 72

Compliance Production Marketing Regulations 72