Agency IQ

JULY 26, 2024

This includes the submission of OMORs, public comments to administrative orders, formal meeting requests and packages, dispute resolution requests, administrative hearing requests, record request responses, as well as updates to drug listing information. Featuring previous research by previous AgencyIQ researcher Kedest Tadesse.

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Advarra

JULY 19, 2022

If you mean using a different contract research organization (CRO) for the different phases of clinical trials – that’s different. Q: What is the typical time period between the submission of the briefing package and the pre-IND meeting? The sponsor is the pharmaceutical company conducting the trial. There is no problem doing this.

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Agency IQ

MARCH 1, 2024

ECHA consultations under BPR closing in March BPR: Potential candidates for substitution These consultations support the evaluating competent authority in assessing the availability of substitutes or alternatives to active substances found to be potential candidates for substitution in accordance with Article 10 of the BPR.

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The Premier Consulting Blog

MAY 4, 2023

The new guidance provides detailed information to applicants and manufacturers regarding compliance with the requirements in 21 CFR Part 4 for ophthalmic drugs packaged with eye cups, eye droppers, or other dispensers. 2] On April 16, 2021, the U.S.

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Agency IQ

DECEMBER 1, 2023

For more background on the glyphosate authorization, see AgencyIQ’s October 12 article.] 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.

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Agency IQ

DECEMBER 15, 2023

PFAS are used to repel water, oil, stains, and increase durability, and are found in a wide array of consumer and industrial products including non-stick cookware, fabric treatments, food packaging, cleaners, textiles, leather, cosmetics, paper and paints, fire-fighting foams (AFFF), and wire insulation.

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Agency IQ

FEBRUARY 12, 2024

Second, the submitters provide a full meeting package with detailed information on the development history and context, available data, and questions. FDA and EMA will review the package and meet to discuss the package before having a meeting with both agencies and the submitter to provide direct insight.

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Agency IQ

JANUARY 4, 2024

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. Two of the package’s proposed acts address the reattribution of tasks among EU agencies associated with chemical safety assessments.

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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). It amends the limit value for the presence of PBDEs in mixtures or articles. regulation, directive, decision).

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Agency IQ

JUNE 28, 2024

Requirements for clinical investigations under the MDR are outlined in MDR Articles 62 – 80 and Annex XV. Other work packages for the ODTF include information about clinical evidence for this device type, conditional certification, and the use of registries to support conformity assessment. Data outside the PMCF (section 9.4)

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Agency IQ

JUNE 9, 2023

Here, we’re starting some deeper analysis of aspects of the proposal package with a look at the impact of orphan drug provisions, seeing what impact the new provisions and the surrounding uncertainty might have on innovation. Additionally, the smaller potential customer base may provide an insufficient return on the investment into research.

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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

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

NOVEMBER 27, 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%

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Agency IQ

OCTOBER 27, 2023

Upcoming Webinar Hosted by Xtalks Webinar/Seminar ( OPEN) Xtalks 11/6/2023 11/6/2023 What is the evidence for high-risk medical devices in the field of cardiovascular disease and diabetes? policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected through Q1 2024.

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Drug Target Review

JULY 18, 2023

This article is the second part of my interview with Olivia Cavlan, Chief Corporate Development and Strategy Officer at Alchemab Therapeutics Ltd, this time exploring the AI applications in personalised medicine, and the evolving landscape of drug development.

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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

MARCH 7, 2024

At conference, ECHA calls for regulatory coherence, collaboration to achieve green and digital transition Last week, EU chemicals regulator ECHA brought together experts from industry, government, civil society, research, and academia to discuss the future of EU chemicals regulation. see AgencyIQ’s article here for background on 1S1A.] “If

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Agency IQ

MARCH 29, 2024

The ideal scenario is to have a clinical trial that prospectively evaluates these endpoints, he said, providing a data package the FDA can use to evaluate such alternative endpoints. Featuring previous research by Kari Oakes. What’s new? To contact the author of this item, please email Rachel Coe ( rcoe@agencyiq.com ).

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Agency IQ

MARCH 1, 2024

Notably, shutdowns can be either total or partial – as noted above, there are 12 appropriations bills, and if a subset of those bills are passed then only those agencies and Departments without an appropriations package will shut down (partial shutdown). If none of the 12 bills are completed, then all government operations shut down.

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Agency IQ

SEPTEMBER 15, 2023

In 2019, the state began to significantly ramp up its PFAS regulation and research. 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

JANUARY 26, 2024

Further, the agency issued guidance in 2021 on peripheral vascular atherectomy devices that focused, in part, on concerns about coating integrity (and coating particulate testing), and has contracted research on long-term effects of other coating materials. That said, there’s little specific guidance from the FDA on coatings more generally.

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Perficient: Drug Development

DECEMBER 13, 2023

Update 1 on my local environment using the Graphical Setup Package for XP Single, I encountered a perplexing roadblock. My journey to resolve this issue led me through various blog articles, support forums, and Slack channels, but a concrete solution remained elusive. In my recent attempt to install Sitecore Experience Platform 10.3

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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.

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Agency IQ

APRIL 12, 2024

The Pharmaceutical Research and Manufacturers of America (PhRMA) also voiced this concern, asking the FDA to provide “additional detail regarding phase appropriate implementation.” Others, such as JDRF International (formerly, the Juvenile Diabetes Research Foundation), suggested that disease-specific guidance documents would be useful.

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Agency IQ

JANUARY 12, 2024

CDER has typically received high marks on meeting these goal dates, but 2023 was different According to AgencyIQ’s analysis of the past 10 years, the FDA’s Center for Drug Evaluation and Research (CDER) has not previously fallen below a 95% annual rate of meeting PDUFA goal dates for New Molecular Entities (NMEs).

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Agency IQ

APRIL 8, 2024

Namely, the use of “social media, market research programs, patient support and assistance programs,” as noted in the concept paper , have now been addressed. For BA/BE studies that do not require INDs (a majority of those used in support of generic drug applications), only a subset of FDA’s regulations regarding clinical research apply.

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Agency IQ

MAY 31, 2024

Shield would be the first blood- based method ; “Guardant Health’s market research found that 64% of patients prefer a blood-based screening test over all other screening methods, including colonoscopy or stool-based tests,” the company has stated , and blood tests do not require preparation or sedation.

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Codon

FEBRUARY 13, 2024

Goodsell, RCSB Protein Data Bank and Scripps Research. With cases of drug-resistant infections on the rise, the article kick-started a renewed interest in this peculiar treatment, which had been virtually forgotten in the Western world since true chemical antibiotics, such as penicillin, became widely available in the 1940s.

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Molecular Design

AUGUST 9, 2020

In this post, I’ll be reviewing an article which suggests that quaternary ammonium compounds could be repurposed for treatment of COVID-19. The study received NIH funding and this may be of interest to researchers who failed to secure NIH funding.

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The Premier Consulting Blog

OCTOBER 11, 2022

In this article, we review two case studies involving the successful use of RWD or RWE in advancing the clinical development of treatments for rare diseases. During that meeting, the sponsor presented data by endpoint, which complemented the data package and indicated the benefits of treatment outweighed the risks.

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Codon

JANUARY 21, 2024

Sign up to receive articles from Asimov Press. With hepatitis C, what changed within the last 10 years was the development of direct-acting antivirals , or DAAs, which are packaged into pills that you can take once a day for a few months. There have been deaths in phase 1 medical and drug research among healthy participants.

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Agency IQ

FEBRUARY 23, 2024

In 2019, the state began to significantly ramp up its PFAS regulation and research. 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

AUGUST 25, 2023

As such, they can be found in myriad applications ranging from raincoats, refrigerants, and lubricants to non-stick pans, food packaging, and semiconductors. years for fluoropolymers used in food and feed packaging for industrial and professional use, to 1.5 See AgencyIQ’s article here for more details on the E.U.’s

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The Premier Consulting Blog

MARCH 7, 2024

The analytical package, consisting of release, stability, and characterization tests, includes data generated throughout the product development and manufacturing process. Therefore, many potency assays are performed as relative potency assays in which the test article is run against a well-characterized reference standard.

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The Premier Consulting Blog

DECEMBER 28, 2023

This article reviews the regulations governing charging or obtaining insurance coverage for an investigational device. CMS has created a checklist to assist sponsors in submitting a complete package. CMS will review each complete submission within approximately 30 days of receipt.

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