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 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 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

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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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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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

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

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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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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Vial

FEBRUARY 23, 2024

In 2022, the global market value of patient portals within the clinical research and healthcare industries was estimated to be US $2.9 billion and is expected to climb at a compound annual growth rate (CAGR) of 19.44% between 2023 and 2030. Factors contributing to digital patient portal usage An observational study by Janssen et al.

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Clinical Trials Clinical Research Trials Hospitals 52

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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Packaging Regulations Laboratories Animal Testing 40

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

JANUARY 12, 2024

CDER’s latest novel drug approvals report shows how the pandemic is still affecting some drug approvals According to a report released this week describing CDER’s approval of 55 novel drugs in 2023, the agency failed to meet its goal dates under the Prescription Drug User Fee Act (PDUFA) Commitment Letter for 11% of applications – a record high.

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KIF1A

OCTOBER 21, 2023

Each week, Dr. Dylan Verden of KIF1A.ORG summarizes newly published KIF1A-related research and highlights progress in rare disease research and therapeutic development. But what regulates the delivery of materials at these early stages?

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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

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.

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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 consultations under the CLP Regulation closing in March CLP: Harmonized classification and labeling (CLH) Consultations on classification and labeling harmonization (CLH) are open for 60 days.

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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

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. In April 2023, the first update ( link is a direct download) from the ODTF indicated that it was working to develop a definition for orphan device.

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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 latest update, announced this week, is known as the Spring 2023 Unified Agenda.

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Agency IQ

MARCH 1, 2024

In this piece, AgencyIQ explains what a government shutdown would mean for FDA’s regulatory processes and for the industry it regulates. AgencyIQ thought this would be a good time to go over what a government shutdown means for the FDA, and therefore what regulated industry needs to know. What does a shutdown mean for the FDA?

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to 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

BY CHELSEY MCINTYRE, PHARMD | OCT 30, 2023 10:57 PM CDT Background: What are microbiome-based therapies? In simpler terms, these are live microbes that have actually demonstrated health benefits in clinical research. What is the microbiome itself? The collective genomes of the micro-organisms that are harbored in the human body.

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Agency IQ

NOVEMBER 27, 2023

The regulations also provided clarification regarding what does not constitute a “true statement,” including false or misleading information, failure to reveal important facts, and/or the lack of a fair balance between side effects/contraindications and effectiveness.

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Agency IQ

DECEMBER 1, 2023

What we expect the EPA to do in December 2023 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. Regan, Case No: 1:16-cv-00364-CRC (D.D.C.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

OCTOBER 27, 2023

What we expect the EPA to do in November 2023 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency (EPA) is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. TSCA risk management rules.

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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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Drug Discovery World

AUGUST 24, 2023

Of course, while the regulation remains a continuous battle, this does not hinder the research being undertaken. As of February 2023, there are no approved therapeutic products containing psilocybin in Canada. To this end, a debate took place in parliament in May 2023 regarding access to psilocybin treatments 6.

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Agency IQ

APRIL 12, 2024

The regulations also explain that this trait can be demonstrated via appropriate laboratory tests or adequately controlled clinical data. Potency assays for cell and gene therapies: The newest guidance At the very end of 2023, the FDA released a draft guidance on establishing CGT product potency to replace its previous 2011 version.

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Agency IQ

JULY 13, 2023

JUL 10, 2023 6:08 PM CDT Regulatory background Asbestos is a mineral fiber that occurs in rock and soil and, due to its fiber strength and heat resistance, has been used in building construction materials for insulation and as a fire retardant. Comments were due by April 17, 2023. BY PATRICIA ISCARO, ESQ. EPA, 947 F.2d

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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. PFAS regulations for drinking water.

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Agency IQ

NOVEMBER 10, 2023

NOV 8, 2023 10:02 PM CST Regulatory background The Federal Food, Drug, and Cosmetics Act (FD&C Act) is administered by the Food and Drug Administration (FDA) and regulates cosmetics. . | MoCRA also requires all marketed cosmetic products to be listed with the FDA by December 29, 2023. BY PATRICIA ISCARO, ESQ. |

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Agency IQ

NOVEMBER 27, 2023

BY KIRSTEN MESSMER, PHD, RAC | NOV 17, 2023 4:46 PM CST Quick background on nitrosamines in global medicinal products Nitrosamines are a large and diverse class of chemicals, with more than 300 different structurally distinct species known today. In a study of more than 12,000 small molecule drugs , researchers found 40.4% guidance.]

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Agency IQ

JUNE 9, 2023

Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. BY KIRSTEN MESSMER, PHD, RAC JUN 5, 2023 10:14 PM CDT Regulatory Background: How things work now Regulation (EC) No 141/2000 (the Orphan Regulation) provides the legal framework for orphan drug designations and incentives.

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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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