Agency IQ

AUGUST 25, 2023

Fill out the form to read the full article. The CAA requires that the EPA periodically review these standards to ensure that each one provides adequate protection for public health and the environment.

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Agency IQ

JULY 22, 2024

Article 33 of both regulations outlines “the setting up, maintenance and management of the future EUDAMED by the Commission,” in conjunction with the Medical Device Coordination Group (MDCG), consisting of one member each from each of the EU Member States and chaired by the EC. The publication of the MDR and IVDR reset the purpose of EUDAMED.

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Agency IQ

AUGUST 11, 2023

Fill out the form to read the full article. Regulatory background Varying global conclusions on the carcinogenicity of glyphosate, sold as an active ingredient in the popular herbicidal product Roundup, have muddied conversations on how it should be regulated in the European Union.

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Cytel

DECEMBER 29, 2022

Perspectives on Enquiry and Evidence explores a wide variety of topics within clinical trial design and data science in the form of expert articles, interviews, ebooks, and more. Here are some of our most read posts of 2022.

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ACTO

NOVEMBER 13, 2023

Read the full article here. The post PM360 Article: Two Key Questions About Data Analytics in 2023 appeared first on ACTO. With this data, Marketing, Sales, and Commercial Training leaders can identify performance promoters or diagnose areas of risk and take immediate action to impact rep behavior and improve drug launch performance.

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Perficient: Drug Development

NOVEMBER 13, 2023

What You’ll Learn from the Piece This article discusses the concept of unified commerce and how it goes beyond omnichannel retail by connecting and synchronizing all channels, systems, and processes, both front-end and back-end, to deliver a consistent shopping experience.

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Agency IQ

AUGUST 18, 2023

Those protections are found at 21 CFR 50 and 56 and include concepts like informed consent, appropriate clinical trial oversight by institutional review boards (IRBs), the review of investigational research protocols by the FDA, and ensuring that test articles have been appropriately vetted prior to human use.

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Drug Discovery World

JULY 25, 2024

This is the latest episode of the free DDW narrated podcast, titled “How to utilise clinical trials in drug discovery” which covers five articles written for Volume 24 – Issue 1, Winter 2022/2023 of DDW. In the fifth and final article, IB Communications’ CEO Michelle Boxall explains why there are two sides to the cell and gene therapy coin.

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Drug Discovery World

JULY 25, 2024

This is the latest episode of the free DDW narrated podcast, titled “How to utilise clinical trials in drug discovery” which covers five articles written for Volume 24 – Issue 1, Winter 2022/2023 of DDW. In the fifth and final article, IB Communications’ CEO Michelle Boxall explains why there are two sides to the cell and gene therapy coin.

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Agency IQ

SEPTEMBER 6, 2023

Fill out the form to read the full article. A pesticide may only be registered in the U.S. if the EPA can confirm that the pesticide will not pose an unreasonable risk to humans or the environment.

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Drug Discovery World

JULY 10, 2024

This is the latest episode of the free DDW narrated podcast, titled “How to utilise clinical trials in drug discovery” which covers two articles written for Volume 24 – Issue 1, Winter 2022/2023 of DDW. In the first article, DDW Editor Reece Armstrong looks into recent research which may explain why cancers can become more aggressive.

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Agency IQ

AUGUST 18, 2023

Fill out the form to read the full article. In addition, OIG releases reports on the different management concerns and investigations that the office undertakes. These reports also include recommendations on what the agency can do to better address internal or external issues in the future.

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Agency IQ

SEPTEMBER 1, 2023

Fill out the form to read the full article. It seeks to protect human health and the environment, while reaffirming the sovereignty of third nations in deciding when hazardous chemicals are allowed to enter their borders.

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Agency IQ

OCTOBER 6, 2023

Fill out the form to read the full article. Quick background: Stimulant use disorder The FDA defines stimulant use disorder as a “substance use disorder (SUD) involving any of the class of drugs that include cocaine, methamphetamine and prescription stimulants.”

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Agency IQ

MAY 28, 2024

Several exemptions are laid out in Article 3 of the DWD , including natural mineral waters, waters which are medicinal products, and water from private, small-scale individual suppliers. Accordingly, water suppliers are required to begin Article 13 monitoring operations by the same date in 2026 for this list of substances.

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Drug Discovery World

JUNE 25, 2024

This is the latest episode of the free DDW narrated podcast, titled “How to utilise clinical trials in drug discovery” which covers three articles written for Volume 24 – Issue 1, Winter 2022/2023 of DDW. and Choosing the right site solution for clinical trials.

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Agency IQ

JUNE 26, 2023

Fill out the form to read the full article. Regulatory background and use profile of PCE (a.k.a. tetrachlorethylene) The Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) performs oversight of the agency as an independent office that is tasked to help the agency run in a more efficient and consistent manner.

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Drug Discovery World

JULY 10, 2024

This is the latest episode of the free DDW narrated podcast, titled “How to utilise clinical trials in drug discovery” which covers two articles written for Volume 24 – Issue 1, Winter 2022/2023 of DDW. In the first article, DDW Editor Reece Armstrong looks into recent research which may explain why cancers can become more aggressive.

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Agency IQ

OCTOBER 12, 2023

Fill out the form to read the full article. HFCs are potent greenhouse gases (GHGs), with some HFCs having hundreds or thousands of times the relative climate impact as carbon dioxide.

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Agency IQ

MAY 10, 2024

BY COREY JASEPH, MS, RAC | MAY 7, 2024 9:35 PM CDT Quick background: The European Ombudsman fields citizens’ complaints on Union institutions The legal basis for a European Ombudsman comes from Article 228 of the Treaty on the Functioning of the European Union (TFEU). In general, the Commission should do more in its feedback efforts.

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Agency IQ

JULY 13, 2023

Fill out the form to read the full article. Regulatory background Under the Toxic Substances Control Act (TSCA), the Environmental Protection Agency (EPA) is required to evaluate the risks posed by existing and new chemicals.

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Agency IQ

JULY 22, 2024

Article 18 prohibits the marketing of cosmetic products that involved animal testing and extends to products using ingredients or combinations of ingredients that were subject to animal testing. See AgencyIQ’s article here for more details on ECIs in general and this initiative in particular.]

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Agency IQ

JUNE 17, 2024

This obligation to adhere to “self-regulation” (“Selbstkontrolle” in German) is laid out in Article 5 of ChemG and Article 26 of USG. see the explanatory document regarding Annex 3 in French) [ For more background, see AgencyIQ’s January 24 article.

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Agency IQ

SEPTEMBER 22, 2023

Fill out the form to read the full article. According to that document, PDURS are “software applications disseminated by or on behalf of drug sponsors for use with one or more of their prescription drug products.”

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Agency IQ

SEPTEMBER 22, 2023

Fill out the form to read the full article. This regulation divides biocidal products into 22 product-types categorized within four main groups: (1) disinfectants, (2) preservatives, (3) pest control, and (4) other biocidal products. Group 1 for disinfectants contains five product-types.

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Drug Discovery World

JUNE 25, 2024

This is the latest episode of the free DDW narrated podcast, titled “How to utilise clinical trials in drug discovery” which covers three articles written for Volume 24 – Issue 1, Winter 2022/2023 of DDW. and Choosing the right site solution for clinical trials.

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Agency IQ

JUNE 2, 2023

Fill out the form to read the full article. Regulatory background and context The FDA uses various controls, including labeling and warnings, to ensure that medical products are used appropriately and safely.

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Agency IQ

JULY 28, 2023

Fill out the form to read the full article. Identity and profile of carbon tetrachloride Carbon tetrachloride (CAS RN 56-23-5), has several synonyms: benziform, carbon chloride, carbon tet, methane tetrachloride, methane, tetrachloro-, methyl tetrachloride, perchloromethane, and tetrachloromethane.

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Agency IQ

JUNE 2, 2023

Fill out the form to read the full article. Regulatory background Per- and polyfluoroalkyl substances (PFAS) are a wide class of synthetic organic chemicals used in many different industrial and commercial applications.

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Agency IQ

JULY 5, 2023

Fill out the form to read the full article. PFAS, PBTs, and EPA regulation Per- and polyfluoroalkyl substances (PFAS) are a wide class of synthetic organic chemicals that are used across industrial and commercial products in a variety of diverse applications.

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Agency IQ

AUGUST 4, 2023

Fill out the form to read the full article. OIG produces reports on various aspects of EPA programs to determine both issues as well as recommendations for how the agency can remedy the issues.

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Agency IQ

JULY 7, 2023

Fill out the form to read the full article. Regulatory background Per- and polyfluoroalkyl substances (PFAS) are a class of synthetic organic chemicals used in many different industrial and commercial applications.

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Agency IQ

AUGUST 11, 2023

Fill out the form to read the full article. Quick background: Optical Character Recognition (OCR) technology systems convert physical, printed, or scanned documents into machine-readable text, as defined by IBM. OCR software can also harness artificial intelligence (AI) to implement more advanced recognition methods.

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Agency IQ

OCTOBER 12, 2023

Fill out the form to read the full article. The topic: Representatives from both centers discussed their recent activities and accomplishments and provided previews of upcoming initiatives and ongoing developments.

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Agency IQ

OCTOBER 6, 2023

Fill out the form to read the full article. Carbon-fluorine bonds are some of the strongest in nature, leading to wide adoption of PFAS for a diverse array of industrial and commercial uses since the chemicals began to be produced.

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Agency IQ

JUNE 17, 2024

Under Article III of the Constitution , a party must have “standing” to challenge a rule or law. Plaintiffs lack Article III standing to challenge FDA’s actions regarding the regulation of mifepristone,” the court wrote. None of these theories suffices to establish Article III standing,” the court added.

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Agency IQ

MARCH 25, 2024

N/A February 6, 2024 MDCG 2024-3 Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices (March 2024) MDCG 2024-3 Appendix A Clinical Investigation Plan Synopsis Template [ Read AgencyIQ’s analysis of the guidance here.]

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