Agency IQ

JUNE 7, 2024

The devil is in the details: a deep dive into the state of Notified Body designations While the European Commission has been laser-focused on the number of medical device and IVD certificates, AgencyIQ is taking a look at progress toward designating Notified Bodies to the European medical device and diagnostics regulations.

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LifeSciVC

DECEMBER 6, 2022

That can be a good thing: for example, when determining inherited traits and regulating critical cell functions. Or a bad thing: for example, when increased expression of certain genes contributes to the formation of cancer.

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Agency IQ

NOVEMBER 20, 2023

Both labels would provide the framework for the consistent placement and order of the regulated portions of pesticide label information, with the digital label organizing the contents as data. The paper elaborates on the benefits of SLs for regulators, users, the regulated community, and the public. and internationally.

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The Premier Consulting Blog

AUGUST 21, 2024

August 2021: [link] Pharmaceutical Regulations in Japan: Drug Development: [link] [link] [link] Stability conditions for WHO Member States by Region, March 2021: [link]

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Agency IQ

MARCH 25, 2024

This proposed rule has been in the works for over 20 years, during which time the regulation of drug compounding has gone through many changes. Efforts to develop the DTC list were placed on hold from 2002 to 2013. Now, the proposed list is out, and its limited length may be a surprise to stakeholders.

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New Drug Approvals

JANUARY 9, 2024

In addition to CDK7, other CDKs have been reported to phosphorylate and regulate RNA pol (II) CTD. Blood, 1, 4307-4312, 1997; The transcriptional non-selective cyclin-dependent kinase inhibitor flavopiridol induces apoptosis in multiple myeloma cells through transcriptional repression and down-regulation of Mcl-1; (Gojoet al.,

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Agency IQ

NOVEMBER 20, 2023

A literature review conducted by the FDA to look at evidence for safety and effectiveness of blood irradiators to prevent metastasis found that, between 2002 and April 2023, there were no reports that evaluated risks or performance issues, though two studies reported that irradiation added some time (less than 20 minutes) to surgical procedures.

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Agency IQ

JUNE 9, 2023

Context on the new guidance In 2002, FDA issued a guidance document on the conduct of IND-enabling nonclinical immunotoxicology studies. Overall, the concepts laid out in the S8 Guideline were well-aligned with FDA’s 2002 guidance. CBER-regulated products are no longer within scope of the guidance.

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Drug Target Review

JUNE 29, 2023

It set a precedent with regulators as to what is expected in some instances. Regarding the NY-ESO programme that we worked on, I started work on that in 2002 before we even knew that we were going to do cell therapy. Numerous organisations are adopting many of the techniques we developed considering that incident.

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FDA Law Blog: Drug Discovery

NOVEMBER 9, 2022

As we have done in the past for the initial and each quinquennial reauthorization of the drug and medical device user fee laws—in 1992 , 1997 , 2002 , 2007 , 2012 , and 2017 —Hyman, Phelps & McNamara, P.C. The memorandum summarizes each section of FUFRA and analyzes the new law’s potential effects on the FDA-regulated industry.

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Agency IQ

JULY 5, 2023

What we expect the EPA to do in July 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.

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The Pharma Data

MAY 13, 2021

Researchers at the University of North Carolina at Chapel Hill have completed an initial analysis of over 300 “Treatment Plans that Worked” between 2002 and 2007, finding strong support for a link between the implementation of these Plans and improvements in child behavior. Watch this video to learn more.

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Agency IQ

JULY 28, 2023

That law built upon several other previous laws, including the Public Health Threats and Emergencies Act of 2000, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Project BioShield Act of 2004. That would leave 19% of staff affected by furloughs.

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BMG Labtech

MARCH 8, 2023

In fact, metabolism should not be considered as a self-regulating entity that is independent of other biological pathways. Alberts B, 2002, Energy Conversion: Mitochondria and Chloroplasts, Molecular Biology of the Cell (4th ed.). On the contrary, cell metabolism affects or is affected by a multitude of processes. 7 (3): 276–82.

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Agency IQ

OCTOBER 20, 2023

In the United States, the Environmental Protection Agency (EPA) has developed a PFAS Roadmap and proposed numerous regulations for managing the effects PFAS has on the environment and human health. 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

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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Codon

MARCH 24, 2024

In 2002, Prodigene, one of the leading “molecular farming” companies, encountered a major setback. In response to this hysteria, regulation was aggressively tightened. ” Progress was rapid until it wasn’t. The company harvested a diagnostic protein from genetically modified corn at its site in Nebraska.

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DrugBank

DECEMBER 4, 2024

In many HIC, pharmaceutical prices are regulated through negotiations between governments and pharmaceutical companies, ensuring patient affordability. However, due to political pressure from HIC and pharmaceutical companies, these flexibilities often need to be more utilized. 

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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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Drug Target Review

DECEMBER 13, 2024

Landscape of clinical drug development of ADCs used for the pharmacotherapy of cancers: an overview of clinical trial registry data from 2002 to 2022. Engineering sites on the antibody to enable specific and consistent attachment of the cytotoxic drug to achieve an optimal drug-to-antibody ratio (DAR). BMC Cancer. 2024;24(1):898.

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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

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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The Pharma Data

DECEMBER 3, 2020

2002;S1-S12. Complement-fixing antibodies against cytomegalovirus in different parts of the world. 1973;49:103-6. 3 De la Hoz, RE., Diagnosis and treatment approaches to CMV infections in adult patients. J Clin Virol. 4 Azevedo LS, Pierrotti LC, Abdala E, et al.

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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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Codon

DECEMBER 12, 2024

A group from Stony Brook in New York made a poliovirus from a chemically synthesized genome back in 2002. Making life from scratch is uncharted territory: this step alone could take a decade or more of troubleshooting. 14 But scientific efforts continue to bear fruit. In 2010, researchers at the J.

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The Pharma Data

MAY 13, 2021

The trans-fat ban–food regulation and long-term health. 2002 Jun;10(6):478-88. Regulation of glucose metabolism from a liver-centric perspective. Adipose tissue regulates insulin sensitivity: role of adipogenesis, de novo lipogenesis and novel lipids. Biochem Cell Biol. 2015 Oct;93(5):466-71. DOI: 10.1139/bcb-2014-0064.

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Codon

AUGUST 10, 2023

Link Gene Expression & Regulation →Genetic regulatory mechanisms in the synthesis of proteins , by Jacob F. & Gene Expression and Regulation. Cell (2002). Link Biological Networks & Mathematics →Network motifs in the transcriptional regulation network of Escherichia coli , by Shen-Orr S.S.

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Codon

AUGUST 10, 2023

Link Gene Expression & Regulation →Genetic regulatory mechanisms in the synthesis of proteins , by Jacob F. & Gene Expression and Regulation. Cell (2002). Link Biological Networks & Mathematics →Network motifs in the transcriptional regulation network of Escherichia coli , by Shen-Orr S.S.

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Drug & Device Law

SEPTEMBER 11, 2023

In our line of work, much of what we do depends on the continuing validity of how the FDA regulates prescription medical products. 1989) (refusing to “upset the FDA’s scheme for regulating drugs and cosmetics”); Mitchell v. 435, 436 (2002). 16, 2023) ( Hippo III ), for our product liability clients, which are significant enough.

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Drug & Device Law

AUGUST 28, 2023

1989) (refusing to “upset the FDA’s scheme for regulating drugs and cosmetics”); Mitchell v. 435, 436 (2002). This result threatens the integrity of the system of federal prescription medical product regulation that has served this country well for nearly a century. E.g. , Estee Lauder, Inc. FDA , 727 F. 1, 6 (D.D.C.

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Drug & Device Law

JUNE 1, 2023

3d 1024, 1033-34 (Alaska 2002) (quoting Coon ) (footnotes omitted). 2002) (citations and quotation marks omitted). 2002 WL 32007200, at *3 (Del. 4, 2002), aff’d , 845 A.2d 2002), the same court took much of that statement back: Frye does not make the trial judge a “gatekeeper” of all expert opinion testimony.

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Drug & Device Law

JANUARY 4, 2024

2002); Tracker Marine, L.P. 2002 WL 32830975, at *4 (Tex. May 15, 2002); Bass v. 341 (2001), and the exclusivity Buckman recognized of FDA authority over approval of the products it regulates also provide grounds for implied conflict preemption those the Complaint’s allegations. See Henry Schein, Inc. Stromboe , 102 S.W.3d

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Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 2002), held that Connecticut law would follow the definition of “product” as “tangible personal property distributed commercially for use or consumption.” at 77 (citation omitted). In United States v. Brown , 348 F.3d

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Drug & Device Law

NOVEMBER 10, 2022

3, 2002) (to be published), the California Court of Appeal held that federal law preempts state law failure-to-warn claims alleging that branded and generic drug manufacturers did not ensure that patients received FDA-approved Medication Guides for amiodarone, a heart medicine. In Amiodarone Cases , No. A161023, 2022 WL 16646728 (Cal.

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Drug & Device Law

AUGUST 7, 2023

2002) (“Under the product liability law of California, injury to the plaintiff from a defective product is an essential element. . ., FDA regulations do not mandate that sunscreen manufacturers include claims pertaining to the product’s durational capability. That provision is: Except as provided in subsection. . . (e). Doe 1 , 881 F.3d

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Drug & Device Law

NOVEMBER 9, 2023

357 (2002); United States v. If unfettered truthful off-label promotion is permissible, then the incentives for regulated entities to spend the large amounts of time and money now required to submit new uses of already approved FDA-regulated products for additional approvals would be reduced. E.g. , Sorrell v. IMS Health Inc. ,

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Drug & Device Law

JANUARY 9, 2023

Then, the decision makes a hash of the relevant administrative record, ignoring what the preemptive FDA regulations said in favor of material from the Federal Register that never actually made it into the regulations themselves. The FDA also promulgated an acetaminophen-specific OTC regulation. 201.326(a)(1).

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