The Pharma Data

MAY 2, 2023

African Parliamentarians rally to boost life-saving laws, regulations on road safety Parliamentarians, policy-makers and experts from 10 African countries met today to strengthen laws and actions to curb the scourge of road crash deaths. Source link: [link]

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Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

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Drug Target Review

JULY 24, 2023

Researchers from Tokyo Tech’s World Research Hub Initiative conducted a study to investigate the regulation of gene expression in the apicoplast of the malaria parasite Plasmodium falciparum. How is melatonin, the circadian signalling hormone, related to the regulation of gene expression in the apicoplast?

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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

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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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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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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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

JULY 31, 2023

Houck — President Barack Obama signed the Comprehensive Addiction and Recovery Act of 2016 (“CARA”) intended to reverse serious prescription drug abuse trend in the United States on July 22, 2016. Three years after that letter, DEA proposed a rule to amend its regulations consistent with CARA on December 20, 2020. By Larry K.

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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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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

FDA conducted the eight-factor scheduling analysis required by the CSA in 2016 and found that marijuana continued to meet the scheduling criteria for remaining in schedule I. 12, 2016); Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed. Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed.

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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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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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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

JUNE 19, 2023

Cato — The long-running saga of FDA regulation of laboratory-developed tests (LDTs) has taken yet another new turn. Over the years we have blogged many times on the twists and turns of the efforts to regulate LDTs. And regulating LDTs through guidance documents is vulnerable to legal challenge on procedural grounds.

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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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Agency IQ

JULY 8, 2024

In a new final rule, FDA carves out a regulatory niche for medical gases Industry has been lobbying FDA and Congress to regulate medical gases different from other types of drug products since the 1970s. FDA can continue to work within this framework to appropriately regulate these products.”

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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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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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New Drug Approvals

SEPTEMBER 29, 2024

At CTAD, the company announced plans for a confirmatory trial, pending discussions with regulators. All were deemed unrelated to drug. There was no evidence of ARIA or other imaging abnormalities. The plan was to test atuzaginstat in people with mild to moderate AD and evidence of P. Examples Example 1. mmol, 1.00 mmol, 7.38 mmol, 8.82

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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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National Institute on Drug Abuse: Nora's Blog

SEPTEMBER 25, 2024

Great progress has been made in reducing smoking in the United States, which has led to major improvements in health, but the rapidly growing vaping industry, if not properly regulated, could jeopardize this. Published March 21, 2016. Prevalence of Problem Gambling: A Meta-analysis of Recent Empirical Research (2016–2022).

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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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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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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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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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The Pharma Data

JUNE 11, 2023

The distinct mode of action of BI 456906 targets multiple pathways pivotal to metabolic regulation, including those associated with obesity and liver diseases,” said Carinne Brouillon, Head of Human Pharma, Boehringer Ingelheim.

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Agency IQ

JULY 7, 2023

Under the framework, new PFAS are expected to be considered persistent, bioaccumulative, and toxic (PBT) chemicals, which invokes another level of regulation for these future PFAS. State regulations have also targeted PFAS levels in consumer products and certain states have already set action levels for PFAS in drinking water.

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Agency IQ

SEPTEMBER 29, 2023

Regulators wanted input on questions related to data access and re-use, to inform its legislative framework on common European data spaces. Two intertwined proposals have been laid out – a regulation on data governance and the proposed data act. Data intermediation service is defined in Regulation (EU) 2022/868.

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Agency IQ

SEPTEMBER 22, 2023

It appears the issue is largely the result of unclear labeling for biocidal disinfectants, an aspect French regulators may flag in future market authorization evaluations for these products. Article 69 of the BPR regulates the labeling of all biocides, including biocidal disinfectants.

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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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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

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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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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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. From the Commonwealth Fund : “West Virginia had not only the highest state rate of “deaths of despair” in 2016 but the biggest increase in deaths from these causes since 2005.”.

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