Perficient: Drug Development

SEPTEMBER 19, 2023

Most Sustainable Dreamforce Ever 74% of structures were recycled or reused 5,500 square feet of biodegradable signage 10M gallons of water conserved 100% compostable meal packaging Multiple Net Zero Cloud sessions New Net Zero Cloud capabilities, including simplified ESG reporting for companies amid changing regulations; Einstein for Net (..)

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Agency IQ

JUNE 16, 2023

FDA set to unveil new rule on Laboratory Developed Tests this August Following challenges getting a diagnostics reform package through Congress, known as the VALID Act, the FDA has just announced that it plans to release a proposed rule in August 2023 that would change the way that the agency effectively regulates laboratory developed tests (LDTs).

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The Premier Consulting Blog

MAY 4, 2023

billion in 2022 and is expected to grow approximately eight percent from 2023 to 2030 [1]. The FDA has determined that ophthalmic dispensers are now regulated as devices, and the drug and device together are regulated as a combination product. The global ophthalmic drugs market size was valued at $33.81

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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

NOVEMBER 20, 2023

BY KIRSTEN MESSMER, PHD, RAC | NOV 13, 2023 8:39 PM CST Background on electronic Product Information The European Commission (EC) has flagged the move to an electronic format for some product information as an area of improvement. readability of package leaflet, patient engagement). readability of package leaflet, patient engagement).

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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. This edition reviews developments that occurred in late 2023 and early 2024. since June 21, 2006.

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FDA Law Blog: Biosimilars

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Test deployment for the changes listed above were deployed to eMDR on August 19, 2022 and will be deployed to production on March 17, 2023.

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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. This is what OIRA is currently reviewing.

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Agency IQ

FEBRUARY 23, 2024

Geological Survey estimating in 2023 that at least 45% of the country’s tap water is contaminated with PFAS. 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 ].

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PPD

OCTOBER 18, 2023

Continued expansion of the biotech industry is occurring in parallel, with an estimated compound annual growth rate of 13.96% from 2023-2030. There has been an unprecedented expansion of different types of pharmaceutical therapies, as well as a change in the overall approach to health care.

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Agency IQ

MAY 10, 2024

Geological Survey estimating in 2023 that at least 45% of the country’s tap water is contaminated with PFAS. 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. with the U.S.

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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

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. In addition, the law prohibits the sale of carpets or fabric treatments containing PFAS as of January 1, 2023.

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FDA Law Blog: Biosimilars

JANUARY 3, 2024

CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA). Palmer & Riëtte van Laack — Most of us love our furry friends, and with the boom in pet ownership during the pandemic, it is no surprise that the market for pet products has become enormous.

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Agency IQ

MARCH 7, 2024

This marks the first update to the list, which first debuted in July 2023. 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.

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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

DECEMBER 15, 2023

WALKER LIVINGSTON, ESQ | DEC 12, 2023 9:01 PM CST PFAS and related regulatory background Per- and polyfluoroalkyl substances (PFAS) are a group of synthetic chemicals that have been in use since the 1940s. TSCA also focuses on regulating chemical substances which may present an unreasonable risk of injury to health or the environment.

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Agency IQ

SEPTEMBER 6, 2023

BY ALEXANDER GAFFNEY, MS, RAC SEP 1, 2023 6:21 PM CDT Regulatory background A warning letter is a significant occurrence for a company, and in particular if it follows an inspection of a company’s facility. What should the meeting request package include?

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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. Carcinogens are classified by the IARC through a series of published monographs , of which there are currently 134 volumes, as of August 2023. For more on the regulation of glyphosate in the E.U.,

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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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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. Published March 21, 2023. Published May 4, 2023. Published 2023. References World Health Organization.

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Agency IQ

JUNE 21, 2024

ECHA committees conclude evaluation of several PFAS uses subject to proposed restrictions ECHA’s committees for risk assessment (RAC) and socio-economic analysis (SEAC) met last week to continue work on developing opinions on the universal PFAS restriction proposal submitted in early 2023.

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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

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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FDA Law Blog: Biosimilars

AUGUST 17, 2023

Tobolowsky — In January 2023, Vanda Pharmaceuticals, Inc. FDA-2023-P-0313 and FDA-2023-P-0344 ) regarding its product Hetlioz (tasimelteon). FDA regulations, at 21 C.F.R. As such, Vanda’s citizen petition stated that these approvals are “clearly erroneous under the FDCA and agency regulations and will put.

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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

DECEMBER 1, 2023

What we expect EU regulators to do in December 2023 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Highlights of chemical regulatory activities Consultations open under the REACH and CLP regulations are coming to an end in December. Events happening next month include two ECHA meetings (i.e.,

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Agency IQ

OCTOBER 6, 2023

BY RAYAN BHARGAVA, MSC | OCT 3, 2023 7:07 PM CDT PFAS background Commonly used in textiles, impregnation agents, paints, firefighting foams (AFFF), and many other applications, per- and polyfluoroalkyl substances (PFAS) have been linked with the incidence of cancer, liver damage, and fertility complications , among other health issues.

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Agency IQ

JUNE 26, 2023

BY AMANDA CONTI, ALEXANDER GAFFNEY, MS, RAC JUN 21, 2023 6:53 PM CDT Background: legislative efforts to bolster rare disease drug development Defining a “rare disease:” In the U.S., legislators have asked the FDA to study the way that rare disease drugs are regulated in the U.S. regulators. Recently, U.S. In particular, Sec.

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Drug Discovery World

MARCH 29, 2023

On January 31 2023, an internally circulated version of the European Commission’s overhaul of the EU’s pharma legislation was leaked, and published by Politico 1. She also does not believe that the problems with Europe’s medicines can be solved with regulation. appeared first on Drug Discovery World (DDW).

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Drug Discovery World

OCTOBER 3, 2023

Plans to overhaul the EU regulation on rare disease therapies risk undermining two decades of progress, a new report claims. The European Orphan Medicinal Product Regulation was introduced in 2000 to incentivise the development of new medicines for people living with rare disease.

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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

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

NOVEMBER 3, 2023

BY KIRSTEN MESSMER, PHD, RAC | OCT 27, 2023 8:03 PM CDT Background on 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.] See AgencyIQ’s analysis of EMA’s milestones.] wide level.

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KIF1A

OCTOBER 21, 2023

But what regulates the delivery of materials at these early stages? In this week’s article, researchers investigated KIF1A’s role in the delivery of synaptic building blocks, and its regulation by the lipid (fat molecule) PI(3,5)P2. Read the Article The post #ScienceSaturday: October 21, 2023 appeared first on KIF1A.

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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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Agency IQ

AUGUST 30, 2024

What we expect EU chemical regulators to do in September 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. A full list of chemical events is also scheduled for September, as regulators and regulatory affairs professionals return to work after the summer holidays.

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