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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Drug Target Review

AUGUST 7, 2024

This continued innovation highlights the complexity of the drug development process, particularly as the field is highly regulated by health authorities around the world. Packaging is typically the patient’s first interaction with a product, and it is critical for communicating safety and benefit-risk information.

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Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

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The Premier Consulting Blog

MAY 4, 2023

The FDA has determined that ophthalmic dispensers are now regulated as devices, and the drug and device together are regulated as a combination product. Therefore, the FDA will examine product classifications, especially for those products that have been regulated as drugs even though they may satisfy the device definition.

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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 will see if FDA is willing to accept those changes later this month.

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Agency IQ

JULY 12, 2024

EPA grants petition on PFAS in fluorinated containers Following a loss at the Fifth Circuit, the EPA has a new plan to regulate PFAS in fluorinated plastic containers: traditional Toxic Substances Control Act Section 6 rulemaking. On December 8, 2023, Inhance petitioned the Fifth Circuit Court of Appeals over the orders from the EPA.

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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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Advarra

JULY 19, 2022

A: For all vendors, having documented qualifications prior to use is important. For GMP vendors, documented reviews of records such as analytical testing and batch records, is also important. The auditor prepares by reviewing relevant information, such as contracts, as well as select QMS documents and records.

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Agency IQ

JULY 26, 2024

EU executive consults on proposed update to PIC chemical lists Regulation (EU) 649/2012 (PIC Regulation) is the main act on the export and import of hazardous chemicals between the European Union and third countries. Part 1 of the annex lists substances that carry the obligation to submit an export notification.

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Agency IQ

SEPTEMBER 6, 2023

But as a new guidance document clarifies, the FDA need to receive certain information from companies to make this meeting type work, and its not in a rush to receive requests, either. That draft guidance document, Post-Warning Letter Meetings Under GDUFA , has just been published. What should the meeting request package include?

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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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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. This is what OIRA is currently reviewing.

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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

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. To contact the editor of this analysis, please email Alexander Gaffney ( agaffney@agencyiq.com ) Key Documents and Dates Maine L.D.

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Agency IQ

FEBRUARY 23, 2024

Background: PFAS regulation in California PFAS have been the subject of significant regulations in California, beginning in the 2010s [for an in-depth review of PFAS regulation in California, see the AgencyIQ analysis here ]. In 2019, the state began to significantly ramp up its PFAS regulation and research.

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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. In this case, the FDA clock start date is determined as the date of receiving the submission by the Document Control Center (DCC). By Philip Won & Adrienne R.

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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

JUNE 26, 2023

Regulation (EC) No 141/2000 (the Orphan Regulation) provides the legal framework for orphan drug designations and incentives.The Orphan Regulation entered into force in January, 2000, outlining requirements for orphan designation and incentives, and establishing the EMA Committee for Orphan Medicinal Products (COMP). regulators.

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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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Drug Discovery World

MARCH 29, 2023

What is likely to be the cumulative effect on innovation of the different losses in exclusivity, also given the forthcoming Patent Package which could link the review’s rules on product shortages to EU-wide compulsory licensing? She also does not believe that the problems with Europe’s medicines can be solved with regulation.

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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. Providing brief points to serve as a guiding point throughout the documents helps reviewers know what is relevant in the application.

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Agency IQ

JUNE 28, 2024

While the limited pre-market clinical data still must be “sufficient,” the document offers potential alternative clinical trial designs and statistical considerations. Notably, this is also the first guidance to describe the possible use of a conditional Notified Body certificate.

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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. See AgencyIQ’s in-depth analysis of this restriction proposal here. ]

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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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Agency IQ

JUNE 21, 2024

Five European nations – Denmark, Germany, the Netherlands, Norway, and Sweden –prepared a proposal in early 2023 that would universally restrict PFAS under Regulation (EC) 1907/2006 on the registration, evaluation, authorization and restriction of chemicals (REACH).

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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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Drug Discovery World

JULY 11, 2022

This fragmented approach to sample management can lead to spiralling sample storage costs, quality concerns, inventory documentation challenges, and poor chain of custody records. As the field matures and the risks are better understood, regulators continue to streamline duplicative and burdensome oversight efforts 5. References .

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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. Many entries in category 2B are only weakly associated with carcinogenicity and are generally unlikely to be regulated for causing cancer. For more on the regulation of glyphosate in the E.U.,

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Agency IQ

NOVEMBER 3, 2023

The Pharmaceutical Strategy document notes that Covid-19 just compounded medicines shortages that had already impacted patient health and the E.U. Regulation (EU) 2022/123 became applicable on March 1, 2022, with the exception of most provisions related to medical devices. See AgencyIQ’s analysis of the proposed regulation.]

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FDA Law Blog: Biosimilars

SEPTEMBER 6, 2023

Still, the document provides some guidance (naturally) as to materials required to submit a successful meeting request. And the Guidance may be used as leverage to secure action from FDA on a meeting request. The Guidance advises that the meeting request not be submitted until “significant progress” toward remediation has been made.

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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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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

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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The Premier Consulting Blog

NOVEMBER 16, 2022

This document is a flexible framework that takes into consideration the type of excipient, physical and chemical properties, existing safety data, proposed use, etc. Involving nonclinical/toxicology experts early on is key to reducing the package of studies as much as possible.

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FDA Law Blog: Drug Discovery

NOVEMBER 2, 2023

The standards would, as stated previously, be voluntary, unless mandated by statute or regulation, and they cannot conflict with existing law or regulation. Consensus does not require unanimity, but a general agreement. Existing published VCS may be identified internally by FDA or externally by stakeholders.

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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. Other consultations ending in August include two addressing potential candidates for substitution and exemption conditions under the Biocidal Products Regulation (BPR), including for the substance DBNPA.

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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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