Agency IQ

OCTOBER 6, 2023

France In January, the French ecology ministry published a PFAS action plan enumerating six objectives for regulating forever chemicals more comprehensively by 2027. These facilities are uniquely categorized under French law so that they may be regulated with greater oversight. agricultural activity, waste processing).

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Pharmaceuticals Regulations Production Pharmaceutical Companies 40

The Pharma Data

OCTOBER 14, 2020

2018) PLoS One. Horsepox-based vaccines are designed to be single dose, vial-sparing vaccines, which can be manufactured on conventional cell culturing systems, with the potential for mass scale production. 1 Noyce RS, et al. 13(1):e0188453. About Tonix Pharmaceuticals Holding Corp.

Vaccine 40

Vaccine Pharmaceuticals Small Molecule Virus 40

Agency IQ

APRIL 8, 2024

FDA updates set the stage for broader use of harmonized standards for safety reporting Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. Periodic Benefit-Risk Evaluation Reports ).

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The Pharma Data

JUNE 18, 2021

Nat Rev Dis Primers 4, 1(2018). RINVOQ ® (upadacitinib) [Package Insert]. Atopic Dermatitis: Global Epidemiology and Risk Factors. Ann Nutr Metab 2015;66(suppl 1):8–16. doi: 10.1159/000370220. Weidinger, S., Atopic dermatitis. doi: 10.1038/s41572-018-0001-z. Eichenfield L.F., Diagnosis and assessment of atopic dermatitis. Upadacitinib.

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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 are the impacts for regulated industry?

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Government FDA Biosimilars Regulations 40

Codon

JANUARY 21, 2024

With hepatitis C, what changed within the last 10 years was the development of direct-acting antivirals , or DAAs, which are packaged into pills that you can take once a day for a few months. And so, there was a lot of debate about that back in 2017 and 2018 , when they were considering these trials in the first place.

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Vaccine Trials Disease Treatment 112

Agency IQ

JANUARY 12, 2024

BY AMANDA CONTI | JAN 10, 2024 9:29 PM CST Quick background: Goal dates under the Prescription Drug User Fee Act (PDUFA) The FDA collects user fees as part of an essential bargain between regulators and industry. In fact, CDER received a perfect 100% for meeting PDUFA dates for novel drugs in 2013, 2017, 2018 and 2020.

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Agency IQ

NOVEMBER 3, 2023

The prebiotic may either feed the probiotic that it is packaged with, or it may feed another beneficial microbe that is intended to complement the activity of the probiotic. The regulation of dietary supplements in the U.S. As the name suggests, a synbiotic is a product that seeks “synergy” from its contents.

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The Pharma Data

APRIL 28, 2021

2018 Aug 25;392(10148):650-661. SKYRIZI (risankizumab) [Package Insert]. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. The Lancet. Reich, K., Sererano, L.,

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The Pharma Data

NOVEMBER 2, 2020

To this end, the Board of Directors shall be entitled to make adjustments to meet foreign regulations or market conditions, including resolving on cash or other settlement if deemed favorable for Oncopeptides based on foreign tax regulations. per cent on a fully diluted basis.

Marketing 40

Marketing Regulations Pharmaceutical Companies Packaging 40

The Pharma Data

FEBRUARY 22, 2021

2018 Jun 23;391(10139):2503-2512. RINVOQ (upadacitinib) [Package Insert]. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial. ClinicalTrials.gov.

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LifeSciVC

APRIL 27, 2023

Much of our success springs from being nimble and pragmatic on the journey: by optimizing areas we know work well and adapting to ever-changing landscapes in the capital markets, therapeutics spaces, and laws and regulations (e.g., For further reading about Nimbus’ second chapter, many excellent blogs were written about this period.

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Small Molecule Computational Chemistry Engineering Clinical Development 40

The Pharma Data

JUNE 18, 2021

Such risks and uncertainties include, but are not limited to, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Europe Globocan 2018. AbbVie Inc.

Treatment 40

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Agency IQ

JULY 13, 2023

Consequently, the 1989 asbestos regulation only bans new uses of asbestos in products that would be initiated “for the first time” after 1989 and flooring felt, rollboard, and corrugated, commercial, or specialty paper. However, the majority of this ban was overturned by Corrosion Proof Fittings v. EPA, 947 F.2d 2d 1201 (5th Cir.

Production 40

Production Packaging Regulations Disease 40

The Pharma Data

JUNE 18, 2021

2018 Aug 25;392(10148):650-661. SKYRIZI (risankizumab) [Package Insert]. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. Reich, K., Accessed on May 21, 2021. Duvallet, E.,

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Disease Treatment Therapies Trials 40

Agency IQ

DECEMBER 15, 2023

The 174 regulations the EPA is currently working on The Environmental Protection Agency has unveiled its Fall 2023 Unified Agenda, which provides a look into the agency’s regulatory agenda for the upcoming year. The expected release dates of the agendas rarely line up exactly with the actual dates when the agency releases the regulation.

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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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Regulations Compliance Production Government 40

Agency IQ

JULY 12, 2024

Regulation (EU) 2022/123 , which called for a “reinforced role for EMA in crisis preparedness and management for medicinal products and medical devices,” expanded EMA’s mandate to monitor and mitigate shortages at the E.U. active pharmaceutical ingredient, fill/finish, packaging/labeling). See AgencyIQ’s analysis of EMA’s milestones.]

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Regulations Production Packaging FDA 40

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.

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Regulations Production Science Compliance 40

Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. This information would be used in considering the regulation of asbestos.

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Regulations Compliance Production Science 40

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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Regulations Compliance Science Production 40

Agency IQ

NOVEMBER 27, 2023

In 2018, NDMA was first detected in the active pharmaceutical ingredient (API) for valsartan, a blood pressure drug. EMA’s investigation ended up revealing even more causes of nitrosamine impurities in drugs, discovering, for example , that formation happened during the heat-sealing process of in certain products using blister-packaging.

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Regulations Production FDA Packaging 40

Agency IQ

AUGUST 11, 2023

In 2018, NDMA was first detected in the active pharmaceutical ingredient (API) for valsartan, a blood pressure drug. EMA’s investigation ended up revealing even more causes of nitrosamine impurities in drugs, discovering, for example , that formation happened during the heat-sealing process of in certain products using blister-packaging.

FDA 40

FDA Science Production Regulations 40

The Pharma Data

MAY 13, 2021

Then these hormones can’t regulate your metabolism like they should…. Additionally, in a 2018 study, published in the journal Phytotherapy Research…. Along with the amount of estrogen-regulating DIM that he added as well. So go ahead and choose your discounted package of HB5 right now…. Once you’ve selected your package….

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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. DARWIN EU).

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Science FDA Research Regulations 40

Codon

MARCH 14, 2023

There are even differences in how their genomic DNA is packaged inside of neurons. ” Other scientists have said much the same thing since at least 2018. ” About 6% of all mouse genes are regulated in sex-specific ways. Nobody really knows why.

DNA 52

DNA Laboratories Engineering Animal Testing 52

Agency IQ

JULY 12, 2024

The 53 regulations that FDA is currently working on The FDA on Friday unveiled its much-anticipated Spring 2024 Unified Agenda, a document outlining the regulations the agency plans to release in 2024 and beyond. Of those 53, seven are new to the Agenda, having never before been included in prior agendas.

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Agency IQ

FEBRUARY 2, 2024

What we expect the EPA to do in February 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. The Agency expects to issue a final rule later in 2023.

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Regulations Compliance Engineering Government 40

Agency IQ

JANUARY 4, 2024

What we expect the EPA to do in January 2024 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.

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Regulations Compliance Government Science 40

Agency IQ

AUGUST 25, 2023

Cannabis groups to Congress: FDA should regulate CBD as a dietary supplement U.S. legislators have asked for help to reimagine how the FDA should regulate cannabidiol (CBD) following the agency’s determination that it could not make use of its existing legislative or regulatory authorities to do so.

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Regulations FDA Science Production 40

Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 2018), rejected a purported duty to modify an electronic product component to disable product use while the user was driving. Ocwen Loan Servicing, LLC , 2018 WL 6599901, at *5 (D. 2018), cert. Brown , 348 F.3d

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