The Pharma Data

MAY 12, 2021

When the Pediatric Regulation (EC No. 1901/2006) came into effect in 2007, the goal was to create an environment where pediatric medicines could be researched and made available without “studies on children or delaying authorization for adults.” Here, “the submission of PIPs is a binary item,” he said. .

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Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The FDA will follow these procedures for both agency-initiated operations (e.g.,

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Common Sense for Drug Policy Blog

JUNE 6, 2024

Analogous substances like post-cycle therapy drugs and human growth hormone, on the other hand, are generally produced in licit pharmaceutical laboratories in jurisdictions with more lax regulations and subsequently imported or removed from domestic pharmaceutical supply chains by illicit actors (Fink et al. 2014 ; Begley et al.

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FDA Law Blog: Biosimilars

APRIL 30, 2023

Subsection 505(q) initially was added by Section 914 of the 2007 FDA Amendments Act (“FDAAA”), Pub. 110-85 (2007), as amended by Section 301 of Pub. It does so by amending FDC Act § 505(q), the current statutory subsection regarding citizen petitions.

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New Drug Approvals

DECEMBER 3, 2022

2] The Bcl-2 family is most notable for their regulation of apoptosis , a form of programmed cell death, at the mitochondrion ; Bcl-2 and Bcl-xL are anti-apoptotic proteins. First developed as a potential cancer chemotherapy , [1] it was subsequently identified as a senolytic (a drug that selectively induces cell death in senescent cells ).

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Dark Matter Blog

JULY 16, 2021

Prior to that, I was CSO at RaNA Therapeutics (now Translate Bio), initially focused on targeting the function of long noncoding RNA in epigenetic regulation, and later transitioning to an mRNA therapeutics company. I had a first-hand role in raising money from Wall Street by being part of an IPO roadshow as Synta went public in 2007.

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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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Agency IQ

MARCH 1, 2024

What we expect the EPA to do in March 2024 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 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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Broad Institute

AUGUST 2, 2023

Known to be a regulator of metabolism, we have found that in addition it has profound behavioral effects in animals and humans, even evident in population-level economic behavior. The Sabatini Lab focuses on the development and regulation of synapses in the brain and the relationship of these processes to behavior and disease.

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Agency IQ

JUNE 7, 2024

BY CHELSEY MCINTYRE, PHARMD | JUN 3, 2024 8:43 PM CDT Regulatory background: DSHEA and dietary supplements The Dietary Supplement Health and Education Act ( DSHEA ) of 1994 defines the FDA’s authority in the regulation of dietary supplement products and dietary ingredients. See AgencyIQ’s deep dive into kratom research and regulation here. ]

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The Pharma Data

OCTOBER 20, 2020

Additionally, the Cancer Therapy & Research Center (CTRC) at UT Health Science Center San Antonio and American Association for Cancer Research (AACR), a prestigious scientific organization known for its basic, translational and clinical cancer research, began collaboration with SABC® in 2007. Contact Information.

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Agency IQ

JANUARY 19, 2024

WALKER LIVINGSTON, ESQ | JAN 17, 2024 8:30 PM CST Background: Clean Air Act and NAAQS Under the Clean Air Act (CAA), the Environmental Protection Agency (EPA) must issue a cornucopia of air quality-related regulations to protect the environment and public health of the country. BY PATRICIA ISCARO, ESQ.,

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Agency IQ

JULY 28, 2023

Regulation of CTC under TSCA On June 22, 2016, the “ Frank R. Laboratory uses of CTC by the DoD would not be prohibited but would be regulated under industrial and chemical use of CTC as a laboratory chemical. Carbon tetrachloride cannot be used as a fire extinguishing agent where employees may be exposed.

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FDA Law Blog: Biosimilars

AUGUST 21, 2023

The GAO Report further explained that the agency did not have the resources to regulate the estimated 100,000 OTC drugs marketed through the monograph process. Recall that the funds provided under the Prescription Drug User Fee Acts (PDUFA) are not available to support the agency’s efforts related to monograph drugs.)

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The Pharma Data

MAY 13, 2021

The IBC Executive Director has produced several videos about EPSDT funding since 2007. Latest Research: Researchers at Thomas Jefferson University in Philadelphia, PA released the results of their analyses of 887 Treatment Plans implemented by staff of the institute for Behavior Change between 2007 and 2010.

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The Pharma Data

MAY 7, 2021

Ensuring data integrity is “a scientific necessity and an ethical must,” and when data are incorrect or incomplete, public harm can result if regulators make decisions based on the faulty foundation of these flawed data. . Additionally, when negative trials are not published, the scientific literature is incomplete.

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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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New Drug Approvals

JANUARY 9, 2024

2007; Ganuza et al., In addition to CDK7, other CDKs have been reported to phosphorylate and regulate RNA pol (II) CTD. This suggests that the CDK7 enzyme complexes are involved in multiple functions in the cell: cell cycle control, transcription regulation and DNA repair. Mar 23;25(6):839-50. May 30; 31(11): 2498-510, 2012).

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The Pharma Data

DECEMBER 1, 2020

AXS-05 is also a sigma-1 receptor agonist; enhances brain levels of serotonin, noradrenaline, and dopamine, which are key neurotransmitters involved in the regulation of mood; and displays anti-inflammatory properties, which may be relevant to treating depression. 2007) Am J. AXS-05 is covered by more than 93 issued U.S.

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Drug Discovery World

JULY 27, 2023

A significant number of patients have benefited in this clinical trial and through EAMS patients can access this combination in routine clinical practice as quickly as possible.” In terms of Innovate UK, which has been in action since July 2007, the impact in a post-Bexit climate on UK innovation and development has been consistent.

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Drug Discovery World

NOVEMBER 3, 2022

At this stage, there needs to be consideration of how the therapy can be managed through different languages both in terms of product labelling and system requirements and how to facilitate accurate scheduling across different time zones and regulations. 15 years later .

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Conversations in Drug Development Trends

MAY 23, 2024

The CRO landscape is rapidly evolving with the recent implementation of the EU Clinical Trials Regulation No 536/2014 (EU-CTR) and the launch of the Clinical Trials Information System (CTIS). This blog delves into the key aspects of the EU regulatory space and provides insights into navigating these changes effectively.

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The Pharma Data

JUNE 18, 2021

Symptoms and Causes. Mayo Clinic. Available at: [link]. Accessed on April 9, 2021. The Economic Cost of Crohn’s Disease and Ulcerative Colitis. Access Economics Pty Limited. Available at: [link]. Accessed April 9, 2021. The global burden of IBD: from 2015 to 2025. Nat Rev Gastroenterol Hepatol. 2015 Dec;12(12):720-7. doi: 10.1038/nrgastro.2015.150.

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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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Perficient: Drug Development

FEBRUARY 22, 2024

The Amazon Kindle was released in 2007. At that time, their industry was driven by government regulations and tariffs. Even after recognizing the pattern, it can still be a tough choice to either go with the trend (gaining predictable short-term revenue) or to choose a different path (with risk and uncertainty).

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The Pharma Data

FEBRUARY 22, 2021

ClinicalTrials.gov. Available at: [link]. Accessed on February 12, 2021. The Economic Costs of Crohn’s Disease and Ulcerative Colitis. Access Economics Pty Limited. Available at: [link]. Accessed on February 12, 2021. The Facts about Inflammatory Bowel Diseases. Crohn’s & Colitis Foundation of America. Available at: [link].

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Drug Target Review

SEPTEMBER 26, 2023

Ther Innov Regul Sci. 2007 Jul;7(4):348–54. Regul Toxicol Pharmacol RTP. Strauss DG, Gintant G, Li Z, Wu W, Blinova K, Vicente J, et al. Comprehensive In Vitro Proarrhythmia Assay (CiPA) Update from a Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA Meeting. 2018;53(4):519–25. Scharfman HE.

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The Pharma Data

JUNE 18, 2021

Symptoms and Causes. Mayo Clinic. Available at: [link]. Accessed on May 21, 2021. The Economic Costs of Crohn’s Disease and Ulcerative Colitis. Access Economics Pty Limited. Available at: [link]. Accessed on May 21, 2021. Duvallet, E., Sererano, L., Assier, E., Interleukin-23: a key cytokine in inflammatory diseases. 2011 Nov;43(7):503-11.

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Drug Discovery World

FEBRUARY 20, 2024

Data Integrity in the Pharmaceutical Industry: Analysis of Inspections and Warning Letters Issued by the Bioresearch Monitoring Program Between Fiscal Years 2007–2018. Ther Innov Regul Sci. DDW Volume 25 – Issue 1, Winter 2023/2024 References Rogers CA, Ahearn JD and Bartlett MG. 2020; 54: 1123-1133.

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Drug Discovery World

FEBRUARY 20, 2024

Data Integrity in the Pharmaceutical Industry: Analysis of Inspections and Warning Letters Issued by the Bioresearch Monitoring Program Between Fiscal Years 2007–2018. Ther Innov Regul Sci. DDW Volume 25 – Issue 1, Winter 2023/2024 References Rogers CA, Ahearn JD and Bartlett MG. 2020; 54: 1123-1133.

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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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Drug Discovery World

SEPTEMBER 16, 2022

For example, in Helsinki, 290 patients were treated under the Advanced Therapies Regulation (EC/1394/2007) which sought to determine rules for patient-by-patient use of gene therapy and cell products. .

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Drug Discovery World

FEBRUARY 15, 2023

However, over the last few decades, it has been widely accepted that interaction between the tumour and host immune response plays a critical role in regulating tumour biology and hence its progression. 2007) 26:29–48. This continues to be the standard of care. Front Immunol. 2017) 8:829. doi: 10.3389/fimmu.2017.00829 Rev Sci Tech.

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Agency IQ

AUGUST 30, 2024

The regulations specify processes for manufactures to submit individual malfunction reports to FDA according to specific timeframes. Under the 2007 FDA Amendments Act (FDAAA), Congress modified the MDR requirements.

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The Pharma Data

NOVEMBER 10, 2020

In 2007, a pioneer study by Professor Ohsawa from Japan discovered that the selective antioxidant capacity and therapeutic effect of hydrogen on cerebral ischemia. Hydrogen is the lightest gas in the world has no toxic effects on humans (biosafety). Effectiveness of molecular hydrogen in treating COVID-19 symptoms.

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PLOS: DNA Science

SEPTEMBER 21, 2023

Two compelling talks will be “Long Noncoding RNAs as Key Regulators of Mood in Women,” from Orna Issler at the Neuroscience Institute at NYU Langone, and “Advising the US Congress and Policymakers on Issues Related to Pathogen Genomics, ” from Sarah Harvey, from the US Government Accountability Office.

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