Agency IQ

FEBRUARY 12, 2024

What’s going on in the world of PFAS – early 2024 edition This feature from AgencyIQ focuses on the wide world of per- and polyfluoroalkyl substance regulation, legislation, and litigation around the United States. This edition reviews developments that occurred in late 2023 and early 2024.

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Agency IQ

MAY 31, 2024

What we expect European regulators to do in June 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. and national regulators.

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Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. and national regulators.

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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. We’re about to find out.

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Perficient: Drug Development

NOVEMBER 22, 2024

Starshot is a game-changer for organizations seeking to elevate their digital strategies, from scalable pre-packaged solutions to AI-driven personalization and seamless updates. Pre-Packaged Recipes for Instant Results Gone are the days of configuring every element of your website from scratch.

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Broad Institute

JULY 10, 2024

Now, researchers at the Broad Institute of MIT and Harvard and the University of Iowa have developed a gene-editing approach that efficiently corrects the most common mutation that causes cystic fibrosis, found in 85 percent of patients. Online July 10, 2024. The new approach also generated 3.5 Nature Biomedical Engineering.

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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.

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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.

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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.

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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. Under REACH, these address testing proposals for five entries, including trimethylolpropane diallyl ether and 5-(hydroxymethyl)-2-furaldehyde.

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Agency IQ

MAY 31, 2024

What we expect EU chemical regulators to do in June 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Another consultation is closing this month on a draft implementing regulation that is amending the label format for fluorinated greenhouse gases (F-gases) under the new F-gas Regulation (EU) 2024/573.

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Broad Institute

MAY 16, 2024

By Allessandra DiCorato May 16, 2024 Credit: Deverman lab Brain vasculature (in blue) surrounded by RNA (in orange) transcribed from the gene delivered to the brain in humanized mice using an engineered AAV targeting the human transferrin receptor.

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Broad Institute

JUNE 27, 2024

By Greta Friar, Whitehead Institute June 27, 2024 Images of a mouse brain show the effect of a technology called CHARM in turning off the expression of a gene in the brain. Previous research has shown that as little as 21 percent elimination of the protein can improve symptoms. Credit: Neumann EN, Bertozzi TM, et al.

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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 is receiving comments until the end of March on one substance being considered for exemption. The European Green Deal sets out the ambition to reach zero pollution for a toxic-free environment.

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FDA Law Blog: Biosimilars

SEPTEMBER 24, 2024

Livornese — FDA issued a Federal Register notice on September 13, 2024, seeking feedback on the Integrated Review format that the Center for Drug Evaluation and Research (CDER) began using as part of its New Drugs Regulatory Program (NDRP) modernization effort several years ago. Comments are due by December 12, 2024.

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National Institute on Drug Abuse: Nora's Blog

SEPTEMBER 25, 2024

Cannabis products are often sold in colorful packages that mimic kid-friendly snack foods, for example, making them appealing to children and to young people. 13 Research from the Adolescent Brain Cognitive Development (ABCD) study shows associations between social media and other forms of screen time and worst mental health outcomes.

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PPD

NOVEMBER 11, 2024

According to the United Nation’s 2024 World Population Prospects data, the global population of those 65 years old and over will grow from 0.8 From an aging population increasing health care demand to urgent, unmet medical needs, there are clear drivers to advance safe and effective medicines to patients faster than ever. billion in 2035.

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The ChEMBL-og

APRIL 16, 2024

A company research code, or Clinical Trial intervention name, is assigned if no standardised name is available. Data set retrieved on 09/02/2024. We are delighted to announce the release of ChEMBL 34, which includes a full update to drug and clinical candidate drug data. University of Dundee: T.

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Agency IQ

JULY 12, 2024

BY WALKER LIVINGSTON, ESQ | JUL 11, 2024 6:28 PM CDT Background: PFAS and TSCA Per- and polyfluoroalkyl substances (PFAS) are a group of synthetic chemicals that have been in use since the 1940s. On April 18, 2024, the EPA announced receipt of the petition and stated that the agency would grant or deny the petitions by July 10, 2024.

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Agency IQ

FEBRUARY 23, 2024

NANCY SKINNER has updated a bill she introduced in early January 2024 to ban the sale of intentionally added PFAS in the state after 2030. BY WALKER LIVINGSTON, ESQ | FEB 22, 2024 2:52 PM CST Background: PFAS Per- and polyfluoroalkyl substances (PFAS) are a wide range of synthetic organic chemicals that have been produced since the 1940s.

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Agency IQ

NOVEMBER 20, 2023

readability of package leaflet, patient engagement). Summary of Product Characteristics and Package Leaflet), recommending that sponsors and regulators “explore the use of electronic media” to provide product information “in the future”. The report recognized the potential for an electronic format for Product Information (i.e.,

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Agency IQ

JULY 26, 2024

BY AMANDA CONTI | JUL 24, 2024 9:57 PM CDT Background: Modernizing regulation of over-the-counter (OTC) products Nonprescription products, also called over-the-counter (OTC) products, must demonstrate the ability to be used safely and effectively without the supervision of a qualified healthcare professional.

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FDA Law Blog: Biosimilars

MARCH 3, 2024

3558 ) on January 25, 2024. Biotechnology equipment includes genetic sequencers, mass spectrometers, polymerase chain reaction machines or any other equipment, components or accessories designed for the research, development, product, or analysis of biological materials as well as any software, firmware, or other digital components.

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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

FEBRUARY 12, 2024

BY AMANDA CONTI | FEB 7, 2024 6:44 PM CST Quick background: complex and hybrid products Complex generics are defined by FDA as products with a complex active ingredient, formulation, delivery route, dosage form or method of administration. Featuring previous research by Lily Rosenfield. For more detail, see AgencyIQ analysis here. ].

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Agency IQ

NOVEMBER 10, 2023

Cosmetics must also be in compliance with the Fair Packaging and Labeling Act ( FP&L Act ); however, only color additives require FDA approval before they may be used in cosmetics. The six month delay for enforcement to July 1, 2024 should allow registrants the time to comply, given the portal is not yet open to accept information.

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Molecular Design

DECEMBER 31, 2023

In a rare example of good practice, one of these publications ( 10 ) (by the drug company Bristol-Myers Squibb) warns researchers that these types of compound undergo light-induced reactions that irreversibly modify proteins. The academic publications generally paint rhodanines as promising for therapeutic development.

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Agency IQ

OCTOBER 27, 2023

policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected through Q1 2024. policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected through Q1 2024.

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Codon

APRIL 9, 2024

However, the blandly clinical package of artemisinin and artesunate tablets reveals little about how the key compound was first discovered. Chinese researchers scoured ancient medical texts containing written records of malaria outbreaks and the plant-derived recipes that were used to treat them nearly two thousand years ago.

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Agency IQ

MARCH 7, 2024

BY WALKER LIVINGSTON, ESQ | MAR 5, 2024 6:33 PM CST Background: Food chemical safety at the FDA The FDA has primary authority over the chemicals used in food, including those used as food additives, colorants, in food packaging and more. The agency also continues research to better understand the health effects of short-chain PFAS.

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Agency IQ

JANUARY 26, 2024

BY CHELSEY MCINTYRE, PHARMD | JAN 24, 2024 4:09 PM CST Back to the beginning: What does an expiration date mean to the FDA? In response to this report, FDA researchers published extensive data on the SLEP program, reviewing the findings for 122 drugs products (3005 different lots) evaluated by the program between 1986 and 2005.

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Agency IQ

DECEMBER 15, 2023

The EPA orders prohibit the nine significant new use notices the company submitted in December 2022 and are effective February 28, 2024. In addition, fluorine gases are used on high density polyethylene (HDPE) plastic packaging to improve container stability. BY PATRICIA ISCARO, ESQ.,

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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.

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Agency IQ

JUNE 16, 2023

The Agenda also includes several long-term actions expected to take place in 2024 and 2025 – included as part of FDA’s long-term regulatory agenda. 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.

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Codon

OCTOBER 27, 2024

Researchers estimate that 2.9 Today, scientists would halt clinical research on drugs with these properties, but back then, many researchers put stock in the “magic bullet” theory proposed by Paul Ehrlich , a German biologist. Researchers next put intense exercise to the test.

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Agency IQ

JUNE 26, 2023

The contract’s period of performance is 16 months, from July 1, 2023, to October 31, 2024, according to a Statement of Work (SOW) accompanying FDA’s notice of intent to Sole Source to NASEM , first noticed by AgencyIQ. The draft report is due within 14 months after contract award, and the final report is due on or before October 31, 2024.

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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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