FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

This of course, make sense—after decades of experience implementing the Hatch-Waxman, Congress and FDA had learned a few new tricks by 2009/2010. FDA explained that its bioequivalence regulations at 21 C.F.R. Those regulations break “concentration” out from strength but only in certain contexts. mg) and the concentration (e.g.,

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Agency IQ

AUGUST 18, 2023

The EPA regulates hazardous waste mostly under the Resource Conservation and Recovery Act (RCRA). These regulations require that hazardous waste generators identify and safely store and dispose of hazardous waste to protect human health and the environment.

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biobide

SEPTEMBER 29, 2023

Nevertheless, in vitro models have important limitations, including the physiological changes the cells suffer when cultivated outside their organs of origin and the loss of the complex intercellular and hormonal communication and regulation present in body organs.

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Common Sense for Drug Policy Blog

JUNE 6, 2024

2018 ; Llewellyn and Tober 2010; Denham 2019 ). The public health challenges of such production are widely reported, encompassing product dosing, hygiene, and contamination (Llewellyn and Tober 2010; Coomber et al.

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Drug Target Review

FEBRUARY 26, 2024

Our data demonstrate that the CoREST complex is a critical mediator of the distinct melanoma phenotypes, working through the regulation of both the phenotype-defining genes MITF and AXL as well as the master regulators of epithelial-to-mesenchymal transitions (EMT) and phenotype switching in melanoma and other cancers, SNAIL/SLUG/ZEB1/ZEB2.

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Agency IQ

JULY 22, 2024

Commission unveils details on plan for phasing out animal testing for chemicals safety At the REACH and CLP regulators’ meeting in July, the European Commission revealed specifics about its formal schedule to eliminate animal testing used for chemical safety assessment.

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Drug Discovery World

OCTOBER 31, 2023

Since 2010, over 100 trials across the world have included NfL measurements as endpoints, and the number of trials is increasing – albeit not as rapidly as it could. The UK’s regulator, the MHRA, has indicated support in its early-stage advice, but suggests more clinical data is also needed.

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Agency IQ

AUGUST 4, 2023

Animal testing has been banned for cosmetic products since 2013 under the EU Cosmetics Regulation. Regulations are legislative instruments that apply across all member states as written. The regulation also obliges sharing information on already registered chemicals and, whenever possible, reducing unnecessary duplication of testing.

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Policy Prescription

JANUARY 31, 2022

state boards of pharmacy to properly regulate pharmacies that irresponsibly and too often illegally profited from opioid drug sales to patients. By 2010 , according to the CDC, nationally, opioid prescriptions began to decline but still remained far higher than in previous periods.

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Drug Discovery World

NOVEMBER 24, 2022

In its 2022 The Pharmaceutical Industry in Figures publication, the EFPIA attributes this downturn to increased regulatory hurdles and escalating R&D costs, as well as fiscal austerity measures introduced by governments across much of Europe since 2010. .

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Agency IQ

SEPTEMBER 22, 2023

In the 1990 amendments to the CAA, Congress established both new requirements and 189 HAPs that the EPA would be required to target for regulation. The CAA requires that the EPA list categories of sources of HAPs, often splitting by industrial group.

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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. 1) When required.

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FDA Law Blog: Biosimilars

AUGUST 18, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. Since 2010, FDA has posted classification orders and decision summaries for devices classified through the De Novo classification process. The classification order identifies the special controls and therefore is extremely important.

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The Pharma Data

NOVEMBER 5, 2020

The resumed session will discuss a 10-year-plan for addressing neglected tropical diseases, as well as efforts to address meningitis, epilepsy and other neurological disorders, maternal infant and young child nutrition, digital health, and the WHO Global Code of Practice on the International Recruitment of Health Personnel, adopted in 2010.

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Agency IQ

MARCH 1, 2024

What we expect EU regulators to do in March 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. ECHA consultations under the CLP Regulation closing in March CLP: Harmonized classification and labeling (CLH) Consultations on classification and labeling harmonization (CLH) are open for 60 days.

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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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The Pharma Data

JANUARY 18, 2021

This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to any securities of Biophytis in any country.

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Agency IQ

DECEMBER 1, 2023

What we expect EU regulators to do in December 2023 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Highlights of chemical regulatory activities Consultations open under the REACH and CLP regulations are coming to an end in December. Events happening next month include two ECHA meetings (i.e.,

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Agency IQ

JANUARY 12, 2024

Exclusions are for substances that are managed by another agency or regulation, such as tobacco , drugs , munitions , food additives , cosmetics , pesticides , or nuclear materials. The most recent version of the document listing the categories is from 2010. EPA proposed updates to New Chemicals Regulations under TSCA in May 2023.

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Drug Target Review

AUGUST 9, 2024

Global efforts to standardise regulations could streamline development processes and eventually improve the likelihood of drug development success. While current and future innovations in drug development hold immense promise, there are potential dangers that have not yet been accounted for in regulatory standards. References Allen, L.

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Agency IQ

FEBRUARY 2, 2024

What we expect EU regulators to do in February 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. BY SCOTT STEPHENS, MPA | JAN 26, 2024 10:22 PM CST Highlights of upcoming chemical regulatory activities Consultations under the REACH and CLP regulations are coming to an end in February.

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The Pharma Data

JANUARY 12, 2021

From 2010 to 2020, Dr Graham was VP of Strategic Program Direction, Immunology and Inflammation at Regeneron Pharmaceuticals, Inc., THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014. Multiple IND’s, NDA/BLA filings and/or defense and multiple successful launches.

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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

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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Drug Discovery World

JULY 13, 2023

The rules and regulations Unlicensed drugs are drugs that have not yet been assessed by a regulator, while off-label use is when an approved medication is prescribed outside of the terms of its license, e.g., for a different disease or in a different patient group.

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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 Strateos Blog: Drug Discovery

DECEMBER 5, 2022

The Alliance fosters pre-competitive collaboration with members working together as equals on projects that will benefit the industry as a whole—whether it is identifying the root causes of inefficiencies, working with regulators to adopt new standards, or helping researchers implement AI effectively—and more!  The

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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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Perficient: Drug Development

NOVEMBER 14, 2023

My son’s part of Generation Alpha, a cohort that includes children born between 2010 and 2025. And games like Mightier combine biofeedback with emotional regulation to teach kids how to control their anger and anxiety. That’s where you as a healthcare marketer come in. The oldest of the Gen Alpha kids are only 13.

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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., ppm since 2011 ( Figure 2- 27 ).

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Agency IQ

OCTOBER 27, 2023

What we expect EU regulators to do in November 2023 Welcome to AgencyIQ’s roundup of upcoming regulatory activities in the EU chemicals sector. Regulation on detergents and surfactants The expert working group on detergents is scheduled to hold a meeting on November 17.

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The Pharma Data

MAY 13, 2021

2010 Jun;17(2):118-24. Regulation of Food Intake and Energy Expenditure. Epub 2016 Feb 17. 2016 May;90:23-8. doi: 10.1016/j.mehy.2016.02.020. 2016.02.020. Epub 2016 Mar 2. 2013 Sep;9(9):539-51. doi: 10.1038/nrneph.2013.145. Epub 2013 Aug 6. [12] 12] Dec 23. pii: S0002-9378(16)46206-X. doi: 10.1016/j.ajog.2016.12.017. 2016.12.017.

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Agency IQ

JANUARY 4, 2024

What we expect EU regulators to do in January 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. ECHA plays a central role in this reassignment of duties, and it would make sense for the basic regulation to be introduced at the same time as these other proposals.

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New Drug Approvals

SEPTEMBER 6, 2024

Toll/IL-1 receptor family members are important regulators of inflammation and host resistance. 11:373-384 (2010)). 10:89-102 (2010)). The Toll-like receptor family recognizes molecular patterns derived from infectious organisms including bacteria, fungi, parasites, and viruses (reviewed in Kawai, T. Nature Immunol., Nature Rev.

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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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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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NIH Director's Blog: Drug Development

MARCH 11, 2014

NIH/NIDDK) [5] The diabetes-susceptible gene SLC30A8/ZnT8 regulates hepatic insulin clearance. 2010 Jan-Feb;2(1):49-50. [7] Nat Rev Drug Discov. 2013 Aug;12(8):581-94. [3] 3] National Diabetes Education Program: Snapshot of Diabetes [4] National Diabetes Statistics, 2011. J Clin Invest. 2013 Oct 1;123(10):4513-24. [6]

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