Agency IQ

MAY 28, 2024

regulator lays out proposal for international device and diagnostics recognition The British medical device regulator just issued its promised framework on international recognition. law as the Medical Devices Regulation 2002 (UK MDR 2002). law as the Medical Devices Regulation 2002 (UK MDR 2002).

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International Regulations Licensing Licensing 40

Elrig

MARCH 25, 2025

Prof Rory Johnson, Associate Professor, University College Dublin, and Dr Shalini Andersson, Vice President Nucleic Acid Therapeutics, AstraZeneca will lead this years event focussed on drugging the undruggable.

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RNA Bioinformatics Science Pharmacokinetics 59

Drug Channels

MARCH 6, 2023

Experts from across the industry will discuss how current and future drug pricing transparency regulations will impact commercialization, reimbursement, pricing and compliance practices. Plus, assess how companies are internally planning for these changes.

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Drugs Compliance Science Government 98

Advarra

JANUARY 13, 2023

New privacy regulations seem to form every few months, especially with individual U.S. states adopting their own privacy regulations (e.g., This means even if you code the data, the international privacy regulations apply – even if the Health Insurance Portability and Accountability Act (HIPAA) does not.

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Clinical Trials Regulations Trials International 52

Alta Sciences

AUGUST 21, 2024

Internships at Altasciences: Q&A With Our Summer Interns nbartlett Thu, 08/22/2024 - 04:44 Internships at Altasciences are more than just a stepping stone—they’re a gateway to real-world-experience and professional growth, giving the next generation opportunities to help shape progress in the drug development industry.

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International Laboratories Science Molecular Biology 40

Drug Target Review

JULY 13, 2023

Drug discovery is a complex and vital field that continually seeks to identify new therapeutic targets and develop effective treatments. In recent years, a novel approach known as condensate biology has emerged, revolutionising the way researchers think about drug discovery and development.

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Disease Small Molecule Cell Biology Drugs 98

DrugBank

JUNE 13, 2024

The landscape of medicine is constantly evolving, and one of the most exciting areas of progress lies in the development of advanced drug delivery systems. These microscopic particles, which are smaller than 100 nanometers, can be engineered to deliver drugs to specific targets with precision.   Take cancer treatment, for example.

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The Premier Consulting Blog

APRIL 13, 2025

On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing in drug development, starting with monoclonal antibodies (mAbs).[ One great example is the FDAs 505(b)(2) New Drug Application (NDA) pathway. Legislation with delayed implementation In 2021, the FDA Modernization Act 2.0

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Animal Testing FDA Drug Development Production 52

DrugBank

APRIL 25, 2024

As the pharmaceutical industry is pushing to deliver new and better drugs while racing against time and budget constraints, it is becoming crucial to not just use artificial intelligence (AI) but truly maximize its potential. AI has already cut down the time for early-stage drug discovery by 25%.

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Clinical Trials Regulations Compliance Government 98

FDA Law Blog: Biosimilars

NOVEMBER 9, 2023

Food and Drug Administration (FDA) issued a proposed rule that would amend its prior notice regulations to add new information requirements and deadlines. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it.

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Regulations FDA Compliance International 52

FDA Law Blog: Biosimilars

JUNE 10, 2024

Walsh — Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” By Sarah Wicks & Anne K. 11-12 of the guidance for a list of these resources). In FY2023, FDA conducted over 1000 inspections under the BIMO program.

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Advarra

MARCH 6, 2025

The Value of Clinical Research Clinical research is the engine that drives medical innovation, leading to the discovery of new drugs, treatments and medical devices that enhance patients access to treatment options, improve patient care and outcomes, and transform the healthcare landscape.

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Clinical Research Research Clinical Trials Bioethics 52

Drug Target Review

SEPTEMBER 26, 2023

These cells demonstrate considerable promise for uncovering drug-induced perturbations to neuronal function such as seizure, and their use extends further to sedation, anti-epileptic drug discovery and modelling of neurological diseases.

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Drugs FDA Disease Animal Testing 111

PPD

JULY 16, 2024

Staying current with PV-relevant regulations and regulatory guidance can be challenging and often requires an FSP PV RI team that spans multiple countries and languages. Food and Drug Administration’s WebTrader, European Medical Agency’s EudraVigilance and several relevant ethics committees.

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Compliance Regulations Production Trials 98

Agency IQ

MARCH 7, 2024

British regulators tease new device regulations in informative live session This week, the British regulator MHRA offered a new peek into its planned medical device regulations. BY COREY JASEPH, MS, RAC | MAR 5, 2024 11:10 PM CST Quick background on medical device regulation in the U.K. post-market regulation here.]

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Regulations International Production Government 40

thought leadership

MAY 7, 2024

Are You Ready for Mandatory EU Health Technology Assessment Regulation (HTAR) Implementation Beginning January 2025? Pharmaceutical companies need to be prepared for the new European Health Technology Assessment Regulation (HTAR), which will take effect in January 2025.

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Pharmaceutical Companies International Regulations Pharmaceuticals 59

Drug Target Review

MARCH 17, 2025

Neuropsychiatric disorders, affecting millions worldwide, disrupt the brain’s intricate processes of mood regulation, cognition and behaviour. Advancing drug candidates across key therapeutic areas Dr John Donello brings over 25 years of experience in pharmaceutical drug discovery, development and collaborations.

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Treatment Licensing Licensing Science 52

FDA Law Blog: Biosimilars

DECEMBER 4, 2023

Federal Court Orders Puerto Rico Pharmaceutical Distributor to Pay $12 Million in Connection with Alleged Failure to Report Suspicious Orders of Pharmaceutical Drugs and Other Controlled Substance Violations, Nov. Providers should be aware of the other drugs prescribed to their patients. 6, 2023 ( DOJ Press Release ). Complaint ¶ 60.

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Pharmacy Government Treatment Compliance 139

LifeSciVC

APRIL 24, 2024

Is a novel target at the inflection point where enough evidence is available to suggest it may prove to be a compelling drug? Suggested resources for this first pass genetics diligence include OMIM, GWAS Catalog, DisGeNET, OpenTargets, Genebass, and the International Mouse Phenotyping Consortium. with antibodies), or correction (e.g.,

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Production Small Molecule Regulations Trials 124

Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Regulations Clinical Trials Production Biosimilars 40

Agency IQ

JANUARY 12, 2024

device regulation timelines To kick off 2024, the British device regulator offered its medical device and IVD plans for this year and next, promising public action on the post-market surveillance regulation by mid-2024 and on the core regulations in late 2024 or early 2025. New roadmap sets out U.K.

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Regulations Government Compliance International 40

Drug Target Review

MARCH 19, 2024

In the current study undertaken by an international team of researchers, co-led by Dr William Reay, we used the genetics of retinol itself as a way to proxy its effect in thousands of traits, including brain structure, vision, and the immune system through causal modelling.

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Laboratories Bioinformatics International Research Laboratories 105

Agency IQ

SEPTEMBER 1, 2023

MHRA introduces an expanded international recognition procedure, while planning to sunset the current EC reliance pathway Today, the U.K.’s On January 24, 2023, the MHRA reiterated the continuation of the ECDRP through 2023, with an extension to “certain other regulators.” from the E.U. pharmaceutical law ceased to apply to the U.K.

International 40

International Regulations Production Marketing 40

New Drug Approvals

APRIL 25, 2025

12] However, absorption, metabolism, and excretion data of taselisib , a molecule with a related chemical scaffold, suggest moderately slow absorption into the systemic circulation, metabolism to play a minor role in drug clearance, and biliary excretion to be the main route of excretion. [13] Food and Drug Administration (FDA).

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FDA FDA Approval Therapies Trials 57

Drug Target Review

OCTOBER 31, 2023

Regulatory affairs workers get to tell a story about a drug to the regulators and – keeping the end in mind, which is the drug label or prescribing information – is a good way to communicate with regulators. Every drug has a story: an end game. It’s never the same thing twice; never the same drug twice.

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Cell Biology Pharmaceuticals Science Disease 107

Conversations in Drug Development Trends

AUGUST 9, 2024

However, implementing adaptive trial designs within MRCTs requires careful consideration of international regulatory standards to optimize patient outcomes and resource efficiency. Harmonizing regulatory requirements and complying with all relevant regulations are crucial for the success of adaptive MRCTs.

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Trials Clinical Trials Regulations FDA 80

FDA Law Blog: Biosimilars

JULY 25, 2023

Recent industry comments submitted to FDA and new, international efforts against these nefarious, potentially carcinogenic organic compounds have the shifting state of regulation here back in the news. The evolving upswing in NDSRI regulation is due to their link to cancer. Koblitz — We need to talk about nitrosamines.

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FDA International Regulations Production 52

Drug Target Review

SEPTEMBER 19, 2023

puts an end to the previous mandate that all drugs need to be tested on animals prior to human clinical trials. 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.

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The Pharma Data

MAY 27, 2022

billion in Medicare funds in 2019 on drugs whose clinical benefits have yet to be confirmed by the Food and Drug Administration, a new study led by researchers from the Johns Hopkins Bloomberg School of Public Health suggests. The program provides drug approval based on what is known as a surrogate endpoint.

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Clinical Trials Drugs FDA Government 52

PPD

FEBRUARY 10, 2025

Sponsors find that an FSP solution is often the best choice to help advance their drug development projects, whether they need to fill small gaps in services or support large-scale programs with dedicated teams across functions.

Clinical Trials 52

Clinical Trials Trials Clinical Research Research 52

FDA Law Blog: Biosimilars

AUGUST 8, 2024

With apologies to Curtis Mayfield) By the close of the public comment period for the Drug Enforcement Administration’s (“DEA’s”) proposal to reschedule marijuana two weeks ago, the agency had received over 43,500 comments. Some states have authorities that regulate marijuana exclusively.

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Regulations Pharmacy Licensing Licensing 59

FDA Law Blog: Biosimilars

APRIL 18, 2023

Houck — In addition to regulating drugs of abuse, the federal Controlled Substances Act (“CSA”) controls the manufacture and distribution of chemicals used in the illicit manufacture of controlled substances. By Larry K. DEA has assigned chemical code 8330 to 4-piperidone.

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Regulations International Drugs 59

The Pharma Data

MAY 17, 2021

The authority to change drug labels outside of considerations for new safety information “could encourage third parties, such as academic investigators, insurance companies, and cooperative trial groups, to initiate such changes,” they wrote. . Posted 17 May 2021 | By Jeff Craven .

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Research FDA Approval Drugs FDA 52

The Pharma Data

MARCH 23, 2021

Sanofi has concluded an agreement to divest an integrated portfolio of its anti-inflammatory drugs to Fidia Farmaceutici, a privately-held company headquartered in Italy. This transaction continues Sanofi’s ongoing strategic transformation by simplifying its portfolio and streamlining to enhance profitability.

Production 52

Production International Drugs Pharmaceuticals 52

Conversations in Drug Development Trends

MAY 1, 2024

The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) has made strides in standardizing technical requirements to streamline pharmaceutical development on a global scale. For example, there are accelerated pathways for oncology drug approval in the U.S., Japan, and China.

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Clinical Research Trials Clinical Trials Research 69

Advarra

JUNE 26, 2023

Food and Drug Administration (FDA) guidelines is critical to the success, failure, or delay of delivering life-changing therapies to market. The inspections are usually done prior to a first market application for new drug applications or routine inspections for ongoing compliance. For sponsors and their sites, adhering to U.S.

FDA 52

FDA Compliance Regulations International 52

The Pharma Data

JANUARY 18, 2021

Food and Drug Administration (FDA) has granted the Company a Breakthrough Device designation for its first-in-class, implantable Atrial Flow Regulator (AFR) for heart failure (HF) patients with preserved (HFpEF) or reduced (HFrEF) ejection fraction. SOURCE Occlutech International. SCHAFFHAUSEN, Switzerland , Jan. Source link.

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