SCIENMAG: Medicine & Health

FEBRUARY 26, 2024

Another mystery is the regulation of cytochrome P450 enzymes (CYPs) in the central nervous system. DCM is the leading cause of heart failure in patients with chronic diabetes. However, the underlying mechanisms of DCM are poorly understood, and treatment options are limited.

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Disease Pharmaceuticals Regulations Treatment 75

Agency IQ

JUNE 9, 2023

Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. 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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Marketing Packaging Regulations Drugs 52

Agency IQ

APRIL 12, 2024

BY KIRSTEN MESSMER, PHD, RAC This week, the European Parliament voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. Fill out the form to read the full article.

Pharmaceuticals 59

Pharmaceuticals Regulations Research 59

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. pharmaceutical law ceased to apply to the U.K. from the E.U.

International 52

International Regulations Pharmaceuticals Production 52

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

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

Agency IQ

JUNE 29, 2023

Regulatory background The FDA’s Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) regulates pharmaceutical advertising in the U.S., Fill out the form to read the full article. including direct-to-consumer advertising.

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FDA Drugs Regulations Pharmaceuticals 52

Agency IQ

NOVEMBER 10, 2023

The adoption of a “fees payable” regulation, Council Regulation (EC) No 297/95 , permitted (and continues to permit) the regulator to assess fees for many of the services it provides to medicines developers. There are other fee-related regulations as well.

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Regulations Pharmaceuticals Government Therapies 40

The Premier Consulting Blog

APRIL 13, 2025

In 2019, we published a detailed peer-review article outlining this process based on our long history of leveraging existing animal and human data to streamline drug development programs and reduce or eliminate animal testing under the 505(b)(2) pathway.[ For questions on NAMs and the impact to your program , contact us. link] [7] H.R.2565

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Animal Testing FDA Drug Development Production 52

Agency IQ

APRIL 12, 2024

The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation This week, the European Parliament voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. has a strong voice in the world. citizens; 2.

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Pharmaceuticals Regulations Packaging Production 40

Policy Prescription

AUGUST 25, 2022

This past June, during a debate in the Senate Health, Education, Labor and Pensions (HELP) Committee, Senator Richard Burr (R-NC), the committee’s Ranking Member, demonstrated that he does not understand very important developments in our nation’s approach to drug regulation and safety. It was almost as if Sen. Burr insulted Italy!

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Drugs FDA Regulations Pharmaceuticals 89

Agency IQ

JANUARY 26, 2024

regulators considered the highest-risk IVD devices, and these and devices for self-test by the patient required Notified Body oversight. The IVDR originally gave stakeholders 5 years to comply with the regulation (May 26, 2022). The directive used a list-based system – List A and List B outlined what E.U.

Regulations 40

Regulations Compliance Laboratories Production 40

Drug Patent Watch

FEBRUARY 26, 2025

Unlocking the Secrets to Patenting Drug Combinations: Strategies and Challenges As a pharmaceutical professional, you know how crucial it is to stay ahead of the curve when it comes to patenting innovative treatments. Read the full article here: [link] What are your thoughts on patenting drug combinations?

Drugs 40

Drugs Production Regulations Therapies 40

Advarra

AUGUST 8, 2024

Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. This article explores the likely impact of the AI Act on software and systems used in clinical research and how it affects entities outside the EU. These risks face fewer regulations but must meet certain standards to ensure ethical use.

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Clinical Research Research Clinical Trials Compliance 98

Agency IQ

JANUARY 19, 2024

With the publication of three proposed legal acts, this concept is one step closer to streamlining the way the bloc regulates chemicals. The ensuing Chemicals Strategy expounded upon the 1S1A concept further, presenting it as the definitive approach to heighten the efficiency, consistency, and transparency of European chemical regulation.

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Packaging Regulations Laboratories Animal Testing 40

Agency IQ

AUGUST 4, 2023

pharmaceutical law ceased to apply to the U.K. s Medicines and Healthcare products Regulatory Agency (MHRA) has been releasing guidance for the pharmaceutical and medical device industry to aid product development and approval after the separation. Pharmaceutical Directive. s official exit from the E.U. as of January 1, 2021.

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Packaging Licensing Licensing Regulations 40

Agency IQ

DECEMBER 11, 2023

The future of ECHA Expect ECHA to extend its competency to the new Serious Cross-border Threats to Health Regulation (2022/2371/EU) soon. for background, see AgencyIQ’s October 18, 2023 article ] McGuinness ended her opening remarks with an endorsement of the prospective ECHA Basic Regulation.

Regulations 40

Regulations Pharmaceuticals International 40

Elrig

MARCH 25, 2025

After PhD and postdoctoral work in the UK and Singapore, Prof Johnson received a prestigious Ramn y Cajal fellowship at the Centre for Genomic Regulation (Barcelona). Dr Andersson has authored over 70 peer-reviewed articles and is a named inventor on six patents.

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RNA Bioinformatics Science Pharmacokinetics 59

Drug Target Review

JULY 4, 2023

In this article, Petra Dieterich, Ian Glassford, and Jeff Mocny, Scientific Leaders at Abzena discuss real-world data that is challenging traditional scientific thinking on the ADC therapeutic window. The global ADC market is expected to continue this steep upward trajectory and is anticipated to exceed $16 Billion by 2026.

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Small Molecule Drugs Clinical Pharmacology Trials 145

PPD

APRIL 30, 2024

31, 2022, the EU Clinical Trial Regulation (EU CTR) 536/2014 became applicable, heralding a new era for clinical trials in the European Union (EU). Transitioning to EU CTR requirements for existing studies Under the regulation, clinical trial applications submitted before Jan.

Clinical Trials 52

Clinical Trials Trials Regulations Pharmaceutical Companies 52

biobide

MAY 18, 2023

Good laboratory practice (GLP) ensures the safety, quality, and organization of pharmaceutical research. The practice is followed to maintain consistently high standards and comply with any regulations set by government agencies, internal company procedures, and international regulations, like the 3Rs.

Laboratories 53

Laboratories International Regulations Government 53

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.

Regulations 40

Regulations Production Engineering International 40

Agency IQ

JUNE 9, 2023

Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. The Orphan Regulation entered into force in January, 2000, outlining requirements for orphan designation and incentives, and establishing the EMA Committee for Orphan Medicinal Products (COMP).

Marketing 40

Marketing Regulations Biosimilars Drugs 40

Agency IQ

NOVEMBER 20, 2023

Summary of Product Characteristics and Package Leaflet), recommending that sponsors and regulators “explore the use of electronic media” to provide product information “in the future”. See also Article 11 of Directive 2001/83/EC.) If the ePI is approved by the regulator, then it will be made publicly available in the ePI database.

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Production Packaging Hospitals Regulations 40

The Pharma Data

JANUARY 20, 2021

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to. There’s absolutely no risk to you.

Drug Trials 52

Drug Trials Trials Compliance Drugs 52

The Pharma Data

JANUARY 11, 2021

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to. There’s absolutely no risk to you.

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Compliance Drugs FDA Regulations 52

The Pharma Data

JANUARY 4, 2021

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to. There’s absolutely no risk to you.

Treatment 52

Treatment Research Compliance Drugs 52

The Pharma Data

NOVEMBER 30, 2020

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to. There’s absolutely no risk to you.

Trials 52

Trials Compliance FDA Drugs 52

The Pharma Data

NOVEMBER 24, 2020

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to. There’s absolutely no risk to you.

FDA 52

FDA Drug Development Compliance Drugs 52

The Pharma Data

NOVEMBER 4, 2020

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to. There’s absolutely no risk to you.

Trials 52

Trials Compliance FDA Regulations 52

The Pharma Data

NOVEMBER 1, 2020

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to. There’s absolutely no risk to you.

Compliance 52

Compliance Trials FDA Regulations 52

The Pharma Data

OCTOBER 22, 2020

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to. There’s absolutely no risk to you.

Treatment 52

Treatment Compliance FDA Regulations 52

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. pharmaceutical law ceased to apply to the U.K. from the E.U.

International 40

International Regulations Production Marketing 40

Agency IQ

MARCH 15, 2024

California publishes draft regulations for landmark plastic pollution reduction act CalRecycle has launched the formal rulemaking process for Senate Bill 54, which will implement a sweeping plan to reduce plastic waste in the state by 2032. However, a producer may also choose to apply for independent compliance with the requirements.

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Regulations Packaging Compliance Production 40

Drug Target Review

JULY 18, 2023

This article is the second part of my interview with Olivia Cavlan, Chief Corporate Development and Strategy Officer at Alchemab Therapeutics Ltd, this time exploring the AI applications in personalised medicine, and the evolving landscape of drug development. Will systems like the NHS be able to deliver it?

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Drug Development Drugs Clinical Development Pharmaceutical Companies 98

KIF1A

JULY 1, 2023

This activity may be regulated by the K-loop, which is known to be important for KIF1A’s long-range movement. Making drug repositioning a part of therapeutic development is a complicated endeavor relying on interactions between regulatory bodies, pharmaceutical companies, rare disease researchers, and patients.

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Small Molecule FDA Approval Disease Pharmaceutical Companies 98

Drug Patent Watch

DECEMBER 10, 2024

In this article, we will explore the importance of regulatory expertise in generic drug development, highlighting the key challenges and opportunities in this field. These agencies set guidelines and regulations that generic drug manufacturers must follow to ensure that their products are bioequivalent to the innovator drug.

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Drug Development Compliance Drugs Regulations 52