FDA Law Blog: Biosimilars

AUGUST 8, 2024

Governors, state cannabis regulators, law enforcement groups and local governments weighed in, as did marijuana advocates and opponents, marijuana industry associations, Members of Congress, federal law enforcement groups, healthcare and human rights groups, unions and trade associations, and private individuals. 21 U.S.C. § 812(c)(c)(10).

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Agency IQ

JULY 22, 2024

The 103 regulations the EPA is currently working on On July 5, 2024, the EPA published its Spring 2024 Unified Agenda, which reveals what regulations the agency is planning on releasing by the end of the year and beyond.

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Drug Target Review

SEPTEMBER 25, 2024

BRAF and downstream mitogen-activated extracellular signal-regulated kinase (MEK) inhibitors are combined to treat BRAF-mutated melanoma, for example. Inhibiting KDM5A, a regulator of cell proliferation, poses another interesting approach. 2016 Jul 1 [cited 2024 Sep 4];12(7):531–8. Available from: [link] 10.Vinogradova

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Agency IQ

MAY 28, 2024

Updates to TSCA new chemicals regulations hit OIRA for review The Office of Information and Regulatory Affairs has begun review of a final rule that will change how the EPA handles new chemical reviews under the Toxic Substances Control Act (TSCA). TSCA itself has numerous subsections focused on different aspects of chemical regulation.

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Agency IQ

SEPTEMBER 15, 2023

PFAS regulation in California (late 2023 edition) California consistently maintains its status as both one of the most important economies in the world as well as one of the most regulated states in the United States. In 2019, the state began to significantly ramp up its PFAS regulation and research.

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Drug Target Review

JULY 4, 2023

The drivers behind the demand for ADCs Providing more targeted therapeutic options in the oncology space has underpinned the rapid growth of the ADC market; between 2016 to 2020, the US ADC market grew by 45 percent to a value of nearly $1.5 Antibody drug conjugated with cytotoxic payload.

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Advarra

DECEMBER 1, 2022

In the past several years, Health and Human Services (HHS) Office of Human Research Protections (OHRP), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH) have announced and/or implemented new regulations to address the challenges of conducting clinical trials involving multiple research sites. An Age of sIRB.

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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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FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Ana Loloei & Allyson B. Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. The new § 820.10

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FDA Law Blog: Biosimilars

JANUARY 15, 2024

Let’s just say, the smackdown—er, decision—eviscerates FDA’s approach to regulating flavored e-cigarettes. Says the Court: “It is perhaps possible that FDA did its part to give the regulated community clear guidance and that one million out of one million not only got it wrong but got it unreasonably wrong. FDA failed on each count.

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The Pharma Data

DECEMBER 15, 2020

Our combined experience cuts across most industries with a specialization in US FDA Quality System Regulations and ISO 13485:2016 Quality Management System Requirements. # # #. We facilitate major change management initiatives, resolve project team limitations, and extend our clients reach through our network and experience.

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Eye on FDA

OCTOBER 19, 2022

Tik Tok was first released in 2016. FDA’s OPDP began considering an approach to regulating social media long before Tik Tok came into being. Studying DTC on broadcast television isn’t going to get us there and an approach to regulating promotional speech in social media is increasingly not platform agnostic.

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FDA Law Blog: Biosimilars

MAY 22, 2023

The California Department of Food and Agriculture (CDFA) issued regulations implementing Proposition 12 on September 1, 2022, but their implementation was enjoined until July 1, 2023, pending the Supreme Court’s decision. Our focus is on the decision’s practical impact, which could be felt almost immediately.

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FDA Law Blog: Biosimilars

APRIL 25, 2023

Note that section 3060(a) of the 21st Century Cures Act in 2016 amended section 520 of the FD&C Act and removed certain software functions from the statutory definition of a medical device. Section 524B(b)(4) of the FD&C Act authorizes FDA to issue regulations with additional requirements for cyber devices. What’s next?

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Agency IQ

APRIL 12, 2024

Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic. In early 2023, AgencyIQ conducted a landscape analysis of DCT policy in the U.S.

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Drug Target Review

SEPTEMBER 26, 2023

Ther Innov Regul Sci. 2016 Sep 1;81:15–20. 2016 Jan 15;96:253–73. Regul Toxicol Pharmacol RTP. 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. J Pharmacol Toxicol Methods. Toxicol In Vitro.

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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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Agency IQ

MAY 26, 2023

EPA proposes amendments to TSCA new chemicals and to remove exemptions for PFAS and PBTs EPA has proposed long-awaited amendments to the Toxic Substances Control Act (TSCA) review of new chemicals to codify practices in keeping with the 2016 TSCA amendments.

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FDA Law Blog: Biosimilars

JANUARY 18, 2024

The company asserts that carbadox residues fall below dangerous levels before the products hit consumers’ plates, and that the Agency’s anti-carbadox bias and failure to follow the mandated regulatory procedures violated the “the FDCA, FDA’s regulations, the APA, and due process.” Carbadox has had a tortured approval history.

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Common Sense for Drug Policy Blog

JUNE 6, 2024

2015 ), with raw powders imported from ‘producer’ countries like China, Egypt, Greece, Thailand, Turkey, and India (Antonopoulos and Hall 2016 ; Brennan et al. As a result, the authors describe the online IPED market as ‘decentralized, highly flexible with no hierarchies, and open to anyone’ (Antonopoulos and Hall 2016 : 708).

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Broad Institute

AUGUST 31, 2023

Through the imposition of a user-defined GRN in its architecture, GRouNdGAN simulates steady-state and transient-state single-cell datasets where genes are causally expressed under the control of their regulating transcription factors (TFs).

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Advarra

JULY 21, 2022

When the human subject protection regulations were originally established, clinical trials primarily took place at academic institutions. In 2016, National Institutes of Health (NIH) announced its Single IRB Policy , requiring domestic awardees and domestic sites conducting NIH-funded multisite research to move to a single IRB of record.

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Advarra

DECEMBER 15, 2022

Policies and Regulations Affecting Single IRB Review. Established in December 2016, this act included a requirement for the FDA to harmonize with other U.S. Health and Human Services (HHS) regulations as much as practicable, which includes sIRB requirements. Working with an sIRB remains completely voluntary in many cases.

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The Pharma Data

NOVEMBER 11, 2020

For this study, Vu and her team looked at more than 1,400 people who vaped in 2016. Food and Drug Administration has announced plans to step up regulation of e-cigarettes. “There should be much closer regulation of what type of devices are allowed to be on the market,” said Bhatnagar, who wasn’t part of the study.

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NIH Director's Blog: Drug Discovery

MAY 9, 2019

If successful, such efforts could revolutionize biology by helping us better understand how allosteric proteins reconfigure themselves in the right shapes at the right times to regulate cell signaling, metabolism, and many other important biological processes. 2016 Feb;13(2):177-183. 2016 Jun 2;12(6):e1004966. Nat Methods.

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Agency IQ

MAY 26, 2023

EPA proposes amendments to TSCA new chemicals and to remove exemptions for PFAS and PBTs EPA has proposed long-awaited amendments to the Toxic Substances Control Act (TSCA) review of new chemicals to codify practices in keeping with the 2016 TSCA amendments. MAY 21, 2023 1:17 PM CDT Regulatory background On June 22, 2016, the “Frank R.

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Advarra

NOVEMBER 17, 2022

In 2016, the Food and Drug Administration (FDA) approved Spinraza (nusinersen). The regulations at 21 CFR part 50, subpart D summarize the additional safeguards for children in clinical investigations. 1] FDA’s regulations at 21 CFR 50.3(o) 2] FDA’s regulations define the term Clinical Investigation at 21 CFR 50.3(c).

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Broad Institute

JUNE 14, 2023

was named president and CEO of Dana-Farber Cancer Institute in 2016. A trailblazer in cancer research, Glimcher's research identified key transcriptional regulators of protective immunity and the origin of pathophysiologic immune responses underlying autoimmune, infectious, and malignant diseases. Glimcher, M.D.,

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Agency IQ

AUGUST 30, 2024

FDA AdComm to discuss patient-centric informed consent The FDA’s Center for Devices and Radiological Health (CDRH) will soon convene its Patient Engagement Advisory Committee to discuss “patient-centered informed consent” policies – notably, not just for medical devices but for “FDA regulated medical products” writ large.

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Drug Target Review

AUGUST 24, 2023

2016 Oct 10;7(1):13119. Cell adhesion molecules and their roles and regulation in the immune and tumor microenvironment. Christine holds a PhD in Molecular Biomedicine from the University of Bonn and an MBA from the University of Potsdam. References Nordenfelt P, Elliott HL, Springer TA. Nature Communications. Walling BL, Kim M.

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Agency IQ

JANUARY 26, 2024

Carper noted that the issues with how the EPA has implemented TSCA has led to “grievances” from both the chemical industry and environmental advocates, as the flow of chemicals to market and regulation of harmful chemicals has slowed. ED MARKEY (D-MA) raised questions that heavily dealt with trichloroethylene (TCE).

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

FDA explained that its bioequivalence regulations at 21 C.F.R. Those regulations break “concentration” out from strength but only in certain contexts. FDA borrowed this definition from 21 C.F.R. Boehringer’s regulatory argument got no further traction. do not help Boehringer’s case.

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The Pharma Data

OCTOBER 21, 2020

Many of those genes are regulated by thyroid hormones, the team noted. These included data on nearly 330,000 children born between 2000 and 2016. A number of genes are suspected to be involved in ADHD. For the study, the researchers looked at records from Kaiser Permanente Southern California hospitals.

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Agency IQ

JULY 12, 2024

Circuit Litigation over the EPA’s new ethylene oxide sterilization rule has attracted a diverse array of petitioners challenging or supporting the agency’s regulation. Circuit received several petitions to review the EPA’s ethylene oxide regulations. Litigants pile into ethylene oxide rule review at D.C.

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Agency IQ

NOVEMBER 10, 2023

The Environmental Protection Agency (EPA) has released proposed regulations that would restrict concentrations of six PFAS in drinking water. The state regulations cover PFAS, and the state considers that the discharge of PFAS into the environment is subject to the state’s hazardous substance regulations. 004 ng/L for PFOA and.02

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Drug Target Review

JULY 1, 2024

SRP-001 targets the central nervous system (CNS) by producing N-arachidonoylaminophenol (AM404) in the midbrain’s periaqueductal grey (PAG) region, crucial for pain sensation and regulation. was founded in 2016 to develop safer, non-opioid therapies for acute and chronic pain. South Rampart Pharma, Inc.

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Drug Hunter

AUGUST 21, 2023

The BBB is composed of specialized brain endothelial cells that regulate the distribution of molecules into and out of the brain from the blood. Unlike the endothelial BBB, the blood-cerebrospinal fluid-barrier (BCSFB) is made up of epithelial cells that similarly regulate the distribution of molecules between the blood and CSF.

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