Agency IQ

AUGUST 18, 2023

A deep dive into MDR and IVDR implementation: Where we are and where we’re going Late last summer, AgencyIQ took a close look at how the European Commission had been meeting its goals in implementing the medical device and IVD regulations (MDR and IVDR, respectively). Fill out the form to read the full article.

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Agency IQ

MARCH 25, 2024

AgencyIQ Guidance Tracker: European medical device and diagnostics guidance documents With the many moving parts of the European medical device and IVD regulations, it can be difficult to keep up on planned guidance and other publications, published documents and document revisions. Our new resource aims to help make this a little bit easier.

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SCIENMAG: Medicine & Health

JULY 5, 2023

This internal clock regulates vital physiological processes including sleep, metabolism, hormonal fluctuations, body temperature, and blood pressure. In 2017, the Nobel Prize in Medicine was bestowed upon researchers who made significant breakthroughs in […]

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FDA Law Blog: Biosimilars

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). This guidance, when finalized, will replace the original version of this document finalized in 2017. By Jeffrey N.

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FDA Law Blog: Biosimilars

MAY 27, 2024

Jennifer was with the firm from 2011-2017, before leaving for in-house roles at Apple, Abbott Laboratories, and Cognito Therapeutics. At Apple, she led executive-level meetings, including with the Chief Operating Officer, regarding regulatory and legal challenges associated with shipping regulated health features.

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FDA Law Blog: Biosimilars

JULY 31, 2023

Three years after that letter, DEA proposed a rule to amend its regulations consistent with CARA on December 20, 2020. Now, in July 2023, DEA has finally issued its final rule amending its regulations for partial filling of prescriptions for schedule II substances. 78,282 (Dec.

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Drug Target Review

OCTOBER 17, 2023

The liver is an essential organ that has a variety of crucial functions in the body, including metabolising nutrients, storing energy, regulating blood sugar levels and detoxifying and removing harmful substances. This promotes tumour growth by regulating the expression of metabolic genes. 2017 July [cited 2023 October 9]; 3(2):45-51.

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Perficient: Drug Development

FEBRUARY 29, 2024

Since 2017, our Acquia practice has demonstrated consistent expertise with Acquia products and cloud hosting services. Our engagements range from implementing Drupal websites and portals to strategizing personalization and customer journeys, including clients in regulated industries like healthcare and financial services.

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Agency IQ

JULY 22, 2024

Updated EUDAMED roadmap projects mandatory use of some processes as early as December 2025 The new EUDAMED roadmap includes updates accounting for the recent amendments to the European medical device and diagnostics regulations, which allow for a phased rollout of the different functional modules of the database.

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FDA Law Blog: Biosimilars

SEPTEMBER 28, 2023

Richard Marschall, a “naturopathic doctor,” had been convicted in 2017 for a misdemeanor violation of the FDC Act for selling misbranded drugs. While Marschall was convicted of a felony based on one earlier 2017 FDC Act conviction, in a footnote, the 9th Circuit notes that this was actually Marschall’s third FDC Act conviction.

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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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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. 2017 ; Greenway and Price 2018 ).

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Perficient: Drug Development

AUGUST 16, 2023

In 2017, the bank was converted from its National Charter to a Kansas state-chartered bank and renamed Heartland Tri-State Bank. Bank Closed By Regulators Almost all bank closures happen on a Friday so that regulators can work all weekend to reopen the bank on Monday.

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Agency IQ

APRIL 8, 2024

medical and diagnostic device regulations established expert panels. Expert panels have two main tasks under these regulations: To provide opinions/views and ad hoc advice. BY COREY JASEPH, MS, RAC | APR 3, 2024 6:20 PM CDT Quick background on the expert panels and the scientific advice pilot The E.U.

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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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Broad Institute

JUNE 14, 2023

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. She has also received the 2017 George M. degree, cum laude , from Harvard Medical School.

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The Pharma Data

APRIL 6, 2021

persons outside the United States in reliance on Regulation S under the Securities Act. In member states of the European Economic Area, this announcement is directed only at persons who are “qualified investors” within the meaning of the Prospectus Regulation.

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The Pharma Data

APRIL 8, 2021

persons outside the United States in reliance on Regulation S under the Securities Act. In member states of the European Economic Area, this announcement is directed only at persons who are “qualified investors” within the meaning of the Prospectus Regulation.

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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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Agency IQ

MAY 10, 2024

But the advice went beyond the specific instance of the reclassification regulation to suggest that the regulator needs to ensure its feedback mechanisms are robust and thorough. In early 2023, the Ombudsman received a complaint on the European Commission’s reclassification regulation on brain stimulation devices.

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FDA Law Blog: Biosimilars

JUNE 28, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won — The Center for Devices and Radiological Health’s (CDRH) Standards and Conformity Assessment Program (S-CAP) encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their product submissions.

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Advarra

DECEMBER 15, 2022

Policies and Regulations Affecting Single IRB Review. Health and Human Services (HHS) regulations as much as practicable, which includes sIRB requirements. This requirement entered the regulations as part of a broader update in 2017, commonly referred to as the Revised Common Rule.

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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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Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. At that time, FDA flagged concerns with functional unblinding and inherent expectation bias.

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Common Sense for Drug Policy Blog

JANUARY 1, 2024

Regulations limiting clean needle and syringe distribution are important operational issues to consider if policy changes supporting harm reduction for PWID are to have optimal impact." M for Philadelphia, $46.8 M for Baltimore). dwf_admin Mon, 01/01/2024 - 15:59 Source Ruiz, Monica S.

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FDA Law Blog: Biosimilars

JULY 24, 2023

Jazz also argues that, notwithstanding the language that instructs FDA to promulgate regulations implementing the clinical superiority provisions at 21 U.S.C. 360cc(c), the statute does not permit FDA to promulgate regulations to use clinical superiority to break ODE.

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FDA Law Blog: Biosimilars

MARCH 5, 2024

Many states have proposed but failed to enact legislation regulating the labeling of APPs, in some cases due to concerns of potential legal challenges based on federal preemption claims. Arizona’s House of Representatives passed a similar bill on February 22 of this year, which is now pending review by the State Senate.

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Agency IQ

NOVEMBER 27, 2023

BY WALKER LIVINGSTON, ESQ | NOV 17, 2023 3:55 PM CST Regulatory background Proposition 65 , formally known as the Safe Drinking Water and Toxic Enforcement Act of 1986, is a regulation that requires businesses to provide warnings to California consumers about significant exposures to chemicals that cause cancer, birth defects, or reproductive harm.

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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. So pharmacies could order scores of powerful painkillers at will with no scrutiny — at least from state regulators. Last year, the state ranked 5th in the rate of drug overdose deaths.

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The Pharma Data

DECEMBER 10, 2020

The Company’s ordinary shares are listed on the regulated market of Euronext Paris under the ticker symbol “NANO.”. Any stabilization action or over-allotment shall be carried out in accordance with all applicable rules and regulations and may be undertaken on the regulated market of Euronext in Paris and on the Nasdaq Global Select Market.

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Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Broad Institute

OCTOBER 4, 2023

Cech also described his own recent research, published in Science , in which he and colleagues used an epigenetic gene-silencing complex essential for cell differentiation and often deregulated in cancers to demonstrate that RNA, in addition to serving as a messenger, regulates the process of transcription itself.

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New Drug Approvals

OCTOBER 24, 2023

. “The Selective Sphingosine 1-Phosphate Receptor Modulator Etrasimod Regulates Lymphocyte Trafficking and Alleviates Experimental Colitis” J Pharmacol Exp Ther. Peyrin-Biroulet L, Christopher R, Behan D, Lassen C (May 2017). Retrieved 13 October 2023. ^ [link] ^ World Health Organization (2017). 369 (3): 311–317.

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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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Advarra

JULY 19, 2022

The regulations require presenting study information in a language understandable to research participants—this includes, of course, the informed consent document and process. Note: This article was originally published August 30, 2017, and has been updated to include new and clarifying information. Enter the short form consent.

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The Pharma Data

JUNE 26, 2021

This press release is prepared in accordance with the exemption from publication of a prospectus under Article 1 4°i) and 5°h) of the Prospectus Regulation (EU) 2017/1129. It constitutes the document required to meet the conditions for exemption from publication of a prospectus as defined by the Prospectus Regulation.

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KIF1A

JUNE 17, 2023

Research to develop new rare disease therapies underway at The Jackson Laboratory In the rare disease space, it takes a village – only through collaboration between clinicians, researchers, regulators, and patients can we develop effective treatments for devastating disorders.

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