Agency IQ

MAY 10, 2024

Recently introduced legislation North Carolina: On May 1, 2024, North Carolina State Representative JOHN AUTRY introduced HB 973 , a bill to ban intentionally added PFAS in food packaging. If passed, the law would go into effect in January 2025.

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Agency IQ

AUGUST 30, 2024

An introduction to EU chemicals guidance In the internet age, meeting regulatory obligations starts with knowing where to pinpoint the right resources in the vast ocean of information to guide you successfully through the often-labyrinthine processes of EU chemicals regulation. how to use and report (Q)SARs?”)

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FDA Law Blog: Biosimilars

MARCH 3, 2024

The Act is intended to address national security concerns by prohibiting certain conduct by regulated industry. The legislation may be revised, and the below is not an exhaustive list of our questions and concerns, but at present we have several observations and questions about how the Act may be implemented and potential consequences.

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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. The length of the carbon chain has traditionally been a factor in how PFAS are regulated or targeted. since June 21, 2006.

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Agency IQ

AUGUST 18, 2023

and internationally Establishing and communicating a substance’s potential to cause cancer is a cornerstone of chemical regulation worldwide. Now the agency will never imply that an agent does not present cancer risk, only that it either is a carcinogen or is simply not classifiable as one with the present level of evidence.

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The Premier Consulting Blog

OCTOBER 11, 2022

During its first meeting with the FDA, the sponsor: Presented data by subject to the FDA in order to underscore changes over time within an individual patient. The agency requested that data be further standardized and presented by primary functional endpoint. The FDA also granted a second meeting for review.

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Agency IQ

JULY 8, 2024

In a new final rule, FDA carves out a regulatory niche for medical gases Industry has been lobbying FDA and Congress to regulate medical gases different from other types of drug products since the 1970s. It also proposed several packaging changes to safeguard against misidentification. The Medical Gas Safety Act , introduced by Rep.

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PPD

SEPTEMBER 6, 2023

Through rebadging, sponsors can maintain continuity on key development programs while avoiding costly severance packages and payouts. For many employees, the rebadging transition presents minimal disruption as they resume the same tasks on familiar projects. Using an FSP model in clinical research benefits employees, as well.

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FDA Law Blog: Biosimilars

JULY 10, 2023

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. We will then present an effective strategy to address FDA’s AI request in a timely manner. By Philip Won & Adrienne R. But that is only the beginning.

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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. for uses under TSCA.

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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.

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Agency IQ

MARCH 15, 2024

The unprecedented volume of comments received during last year’s public consultation means EU regulators have had to resort to exceptional measures in the REACH restriction procedure as they seek to maintain transparency, objectivity and a high level of quality.

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Agency IQ

JUNE 7, 2024

Almost 10 years late, the new framework’s arrival will represent significant changes in the regulation of these pesticide substances. Active substances that have been approved for use in the EU are listed in the Annex of Regulation (EU) No 540/2011; currently, approximately 450 entries are listed.

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Agency IQ

NOVEMBER 27, 2023

In relation to the presentation of information on side effects, contraindications and effectiveness, the requirements clarify that “side effects and contraindications” includes side effects, warnings and precautions, as well as any relevant information under headings such as cautions, special considerations and important notes.

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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.

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National Institute on Drug Abuse: Nora's Blog

SEPTEMBER 25, 2024

Great progress has been made in reducing smoking in the United States, which has led to major improvements in health, but the rapidly growing vaping industry, if not properly regulated, could jeopardize this. Past, Present, and Future. Prevalence of Problem Gambling: A Meta-analysis of Recent Empirical Research (2016–2022).

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Thus, the current reality of gene therapy products presents a conundrum to FDA: If you have an efficacious one-time treatment, how long do you wait to see if the treatment stops working or stops working as well, while patients receive very real benefits in the interim? That brings us to the product’s approval.

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The Pharma Data

JUNE 18, 2021

1 This is the first presentation of data from these two studies, ADVANCE and MOTIVATE, following the announcement of top-line data earlier this year. 1 This is the first presentation of data from these two studies, ADVANCE and MOTIVATE, following the announcement of top-line data earlier this year. NORTH CHICAGO, Ill. , AbbVie Inc.

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Agency IQ

SEPTEMBER 22, 2023

It appears the issue is largely the result of unclear labeling for biocidal disinfectants, an aspect French regulators may flag in future market authorization evaluations for these products. Article 69 of the BPR regulates the labeling of all biocides, including biocidal disinfectants.

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Agency IQ

JANUARY 19, 2024

Commission unveils “one substance, one assessment” reform package The Commission has long aspired to realize its one substance, one assessment concept in the EU’s chemical regulatory regime. With the publication of three proposed legal acts, this concept is one step closer to streamlining the way the bloc regulates chemicals.

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FDA Law Blog: Biosimilars

AUGUST 17, 2023

FDA regulations, at 21 C.F.R. The difference at issue here is the fact that Vanda’s Hetlioz product includes braille writing on its packaging, with some accompanying language (“Do not cover Braille”), and the generic products’ labeling does not. patients in harm’s way.” FDA responded in late July, denying Vanda’s petitions.

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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

JUNE 21, 2024

Likewise, some have the propensity to travel great distances via air and sea currents, presenting a collective action problem that concerns the entirety of the EU. At their November meetings, the two committees will discuss fluorinated gas applications; as well as applications related to transport and construction products.

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Agency IQ

JUNE 28, 2024

Generally, how have states attempted to regulate PFAS? States are attempting to regulate PFAS in a variety of ways, including via multiple in-state regulatory and legislative avenues. Used products and used product components are officially exempted from the regulations, as well as manufacturers that employ 25 or fewer people.

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Advarra

JUNE 28, 2022

There are a myriad of regulations coming into play during the drug development process. Because of this, the FDA understands sponsors may need help making sense of regulations. Conversely, failing to present the information concisely is a major flaw. Failure to Have a Pre-Investigational New Drug (IND) Meeting.

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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. A former EPA assistant administrator, Jones has focused much of his career on chemical regulation.

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Vial

FEBRUARY 23, 2024

A number of factors are contributing to this increase in popularity of digital patient portals, including the surge in telemedicine needs following the COVID-19 pandemic, technological advances enabling better integration of mobile-based health platforms, as well as federal regulations shifting to accommodate remote data accessibility.

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Agency IQ

OCTOBER 6, 2023

The EU concluded that PFAS’ propensity to travel great distances over air and sea currents presents a collective action problem best addressed at the EU level. France In January, the French ecology ministry published a PFAS action plan enumerating six objectives for regulating forever chemicals more comprehensively by 2027.

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Agency IQ

SEPTEMBER 15, 2023

PFAS regulation in California (late 2023 edition) California consistently maintains its status as both one of the most important economies in the world as well as one of the most regulated states in the United States. In 2019, the state began to significantly ramp up its PFAS regulation and research.

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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.

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Agency IQ

NOVEMBER 3, 2023

Regulation (EU) 2022/123 became applicable on March 1, 2022, with the exception of most provisions related to medical devices. The regulation expanded EMA’s mandate to monitor and mitigate shortages, as well as establish lists of critical medicines during major events that affect public health. [See wide level.

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Agency IQ

FEBRUARY 15, 2024

European Commission unveils proposed ban on bisphenol A in food packaging The European Commission has proposed a total ban on bisphenol A and related substances for use in food contact materials. Other common food contact products where BPA is present are printing inks, adhesives, ion-exchange resins, and rubbers. eye damage, cat.

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Agency IQ

JUNE 28, 2024

BY COREY JASEPH, MS, RAC | JUN 26, 2024 11:15 PM CDT Quick background on clinical evaluation and investigation requirements under the European medical device regulation The E.U. Those criteria are that the device is intended to benefit patients with a disease or condition present in 12,000 or fewer people in the E.U.

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Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

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Agency IQ

NOVEMBER 20, 2023

During an annual update on the program and its various workstreams, regulators and researchers discussed ongoing projects at Sentinel, its work under the current Prescription Drug User Fee authorization (PDUFA) program and next steps in using active surveillance for regulatory purposes. Analysis and what’s next? DARWIN EU).

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Agency IQ

AUGUST 23, 2024

ECHA issues guidelines for enforcing mixture classification based on bridging principles ECHA has issued a new guide for national enforcement authorities (NEAs), clarifying the tiered approach to mixtures classification under the CLP Regulation and strategies for reviewing duty holders’ classifications of hazardous mixtures.

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The Pharma Data

MARCH 25, 2021

Along with the scientific opinion issued by the Committee for Medicinal Products for Human Use (CHMP), national regulators in countries participating in the EU-M4all procedure will conduct their own assessments to determine if national marketing authorizations for TAK-003 are granted.

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