FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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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 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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FDA Law Blog: Biosimilars

SEPTEMBER 11, 2023

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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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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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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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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Drug Target Review

AUGUST 9, 2023

14 TDP-43 is a DNA and RNA binding protein that regulates the expression and splicing of several target transcripts. Stathmin-2 is one of many proteins that appear critical for the growth and stabilisation of axons, most likely by regulating the dynamics of axonal microtubules.

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NIH Director's Blog: Drug Development

FEBRUARY 27, 2018

In an analysis of more than 28 million papers in the PubMed.gov database , researchers found NIH contributed to published research that was associated with every single one of the 210 new drugs approved by the Food and Drug Administration from 2010 through 2016 [1]. Reference: [1] Contribution of NIH funding to new drug approvals 2010-2016.

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Drug Target Review

SEPTEMBER 19, 2023

This major shift to the orthodox tradition of using animal experiments in drug testing dates back the Aristotle’s time and cemented 80 years ago with initial federal mandate of drug safety regulation of 1938. The first successful chip adaptation to a lung model was first described in 2010 by Donald Ingber, a bioengineer at Wyss institute.

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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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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 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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FDA Law Blog: Biosimilars

APRIL 16, 2024

To address concerns that manufacturers were making minor changes to drugs in order for them to be characterized as new covered outpatient drugs with updated (and higher) baseline AMPs, Congress amended the statute in 2010 to add an alternative rebate for line extensions of oral dosage form single source or innovator multiple source drugs (i.e.,

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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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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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Drug Target Review

SEPTEMBER 26, 2023

Ther Innov Regul Sci. 2010 Aug;31(4):331–50. 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. Rockley KL.

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Perficient: Drug Development

NOVEMBER 21, 2024

CFPB 1033 open banking requires financial firms to ease personal financial data access for consumers CFPB first proposed the rule in the Federal Register on October 31, 2023, accepted public comments on the regulation though December 29, 2023, then issued its final rule November 18, 2024.

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FDA Law Blog: Biosimilars

APRIL 3, 2023

In 2010, concerned that manufacturers were making minor changes to a drug merely so that it could be characterized as new covered outpatient drug with an updated baseline AMP, Congress added to the statute an alternative rebate for line extensions of oral dosage form innovator (i.e., See our memo summarizing CMS’s regulation here.

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Drug Target Review

FEBRUARY 28, 2024

Prior to that, Mr Ho was at New Leaf Venture Partners, a leading healthcare venture capital firm, where he launched and managed the public investments and cross-over portfolio, and served as its Public Investment Director from 2010 to 2014. Regulation of cutaneous malignancy by gammadelta T cells. J Hemotother 5(5):503-9 (1996).

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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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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

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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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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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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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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Agency IQ

MARCH 25, 2024

Updates from IMDRF: What’s next for the working groups At the International Medical Device Regulators Forum (IMDRF) annual meeting in Washington, DC, regulators presented updates on the work underway within all seven IMDRF working groups. The group began with regulators from Australia, Brazil, Canada, China, the E.U.,

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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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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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Eye on FDA

JULY 7, 2020

Then as part of the agency’s effort at putting together a regulatory stance regarding the unique questions posed by the huge migration into digital and social communications, FDA later that year posed a series of five questions to inform the regulation of this burgeoning environment during a public meeting held that same year.

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Agency IQ

SEPTEMBER 1, 2023

s MHRA unveiled details of its new International Recognition Procedure, which will allow the MHRA to rely on marketing authorizations by reference regulators from several countries for a wide range of products, including generics and those that received expedited review. from the E.U. pharmaceutical law ceased to apply to the U.K.

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Agency IQ

SEPTEMBER 29, 2023

The Commission has prepared a draft implementing regulation for the active substance that is expected to be presented for a final vote at PAFF’s upcoming meeting. Proposal for a regulation Initiative entry Chemicals – making best use of E.U. Proposal for a regulation Initiative entry E.U. CLP revision.

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Codon

JUNE 18, 2024

For more than a century, scientists thought of gas vesicles as little more than a natural curiosity and, later, as a way for microbes to regulate buoyancy. Right) The passage of text from a 2010 review that inspired Mikhail Shapiro to engineer gas vesicles. Voigt, Biotechnology Journal (2010). 31,500x magnification.

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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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The Premier Consulting Blog

APRIL 27, 2023

However, the ICH M8 EWG/IWG was reestablished in November 2010 to oversee the next eCTD update and create a more robust, more flexible, and longer-term messaging system between sponsors and regulatory agencies. Technical Conformance Guide HL7 Version 3 Implementation Guide: Regulated Product Submission, Release 1 was finalized.

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Agency IQ

JUNE 9, 2023

Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. BY KIRSTEN MESSMER, PHD, RAC JUN 5, 2023 10:14 PM CDT 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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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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