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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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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Agency IQ

JUNE 7, 2024

Safeners and synergists are subject to the same approval conditions that active substances are under the PPPR’s Articles 4 and 5-21 , pursuant to Article 25(1)-(2). Under the PPPR, first-time approvals are expected to take between 2.5 PPPs using approved active substances must obtain separate authorizations at the national level.

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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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Agency IQ

AUGUST 30, 2024

Today, the steps for creating chemical regulatory guidance are laid down in ECHA documents, including the Provision of new guidance and guidance update (PRO-0012) and the Consultation procedure for guidance (PRO-0011.11). Finally, the Support tab provides users links to contact the authorities to obtain regulatory (REACH, CLP, BPR, PIC, etc.),

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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

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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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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Drug Target Review

AUGUST 30, 2023

Advancing drug discovery for pain disorders: human iPSC-based approach Drug discovery relies on the use of relevant model systems. Most new targets have been discovered using animal models, which while useful, are not sufficiently predictive of human safety and efficacy.

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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

AUGUST 9, 2024

Specifically, the EU executive’s proposal seeks to harmonize the POPs Regulation, carving out exclusions for mechanical separators in blood collection tubes, triacetyl cellulose film in polarizers, and photographic paper, among other exempted articles containing UV-328. They may be used until the end of their service life.

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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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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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FDA Law Blog: Drug Discovery

MARCH 19, 2023

s Mark Tobolowsky co-authored the peer-reviewed article “ Microdystrophin Expression as a Surrogate Endpoint for Duchenne Muscular Dystrophy Clinical Trials ” in the recently published edition of Human Gene Therapy. Hyman, Phelps & McNamara, P.C.’s

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Agency IQ

AUGUST 23, 2024

In accordance with Article 9(3) , when the CLP Annex I criteria on classification “cannot be applied directly to available identified information,” duty holders are required to “carry out an evaluation by applying a weight of evidence determination using expert This su in accordance with section 1.1.1 As per section 1.1.3

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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

FEBRUARY 15, 2024

They vary from articles like reusable bottles and tableware, to waterpipes, sports equipment, flexible glass applications, CDs and DVDs, and many more. BPA has been identified as a substance of very high concern (SVHC) under REACH , satisfying the Article 57 criteria for reproductive toxicity (Art.

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Agency IQ

SEPTEMBER 29, 2023

Fill out the form to read the full article. The intent is to create a single market for data, establish common European data spaces, and allow the companies that generate the data to keep control and maintain trade secrets.

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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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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

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 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

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

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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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 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

JANUARY 26, 2024

Described in MDR Article 78 and IVDR Article 74 , the coordinated procedure allows sponsors to submit a single application for a clinical investigation (medical device) or performance study (IVD), rather than an application to each Member State.

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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

JUNE 9, 2023

Fill out the form to read the full article. 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

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

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

SEPTEMBER 6, 2023

Fill out the form to read the full article. A warning letter represents the FDA’s determination that a manufacturer has “ significantly violated” FDA regulations, including those related to current good manufacturing practices (CGMPs).

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Agency IQ

JANUARY 19, 2024

The Omnibus Regulation has four main articles reattributing responsibilities across the four EU agencies primarily concerned with chemical regulation. Article 2 adds near identical cooperation obligations to the EEA by amending its founding regulation. Article 3 redirects tasks to ECHA regarding medical devices.

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