ASPET

SEPTEMBER 28, 2023

The family of serum-glucocorticoid-regulated kinase (SGK) consists of three paralogs- SGK-1, SGK-2 and SGK-3 with SGK-1 being the better studied. Indeed, recognition of the role of SGK-1 in regulation of cell survival and proliferation has led to introduction of a number of small-molecule inhibitors for some types of cancer.

Regulations 100

Regulations Small Molecule Disease Research 100

PPD

FEBRUARY 19, 2024

The European Union Clinical Trial Regulation (EU CTR) brings the biggest change in the regulatory landscape since the implementation of the EU Clinical Trials Directive in 2004, requiring vast changes in the way organizations are structured and conduct their day-to-day activities.

Clinical Trials 96

Clinical Trials Regulations Trials Clinical Research 96

Advarra

JULY 26, 2022

Importantly, the 2018 Farm Bill preserved FDA authority to regulate products with cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic (FD&C) Act and Section 351 of the Public Health Service Act. The post CBD Research: A Dive into the Regulations of Cannabis Research appeared first on Advarra.

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Regulations Research FDA FDA Approval 97

Drug Patent Watch

DECEMBER 11, 2024

Pharmaceutical companies should evaluate a CDMOs compliance with industry standards and regulations, ensuring that they have a robust quality assurance system in place. This peer-to-peer perspective offers invaluable information, empowering pharmaceutical companies to make an informed decision. 2019, March 6). Contract Pharma.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceuticals Compliance Drug Development 98

Agency IQ

MARCH 29, 2024

BY WALKER LIVINGSTON, ESQ The White House Office of Information and Regulatory Affairs has cleared a final rule that will implement the first national drinking water regulations for per- and polyfluoroalkyl substances. The rule, once released, will set the tone for future PFAS regulation in the U.S.

Regulations 59

Regulations 59

FDA Law Blog: Biosimilars

SEPTEMBER 19, 2023

Karst — Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. The bill proposes to amend FDC Act § 505(b) and PHS Act § 351(a)(2) with respect to patent information submitted to FDA for Orange Book and Purple Book listing. Koblitz & Kurt R.

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FDA Drugs Biosimilars FDA Approval 105

Drug Patent Watch

DECEMBER 9, 2024

This involves working closely with regulators to ensure that the analytical characterization and clinical trial design meet the necessary standards for approval. National Center for Biotechnology Information. National Association of Managed Care Physicians. link] Kurki, P., 2021, November 2). link] Algorics. 2023, June 13).

Biosimilars 97

Biosimilars Clinical Trials Immune Response Trials 97

Agency IQ

AUGUST 30, 2024

By Laura DiAngelo, MPH 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.

FDA 52

FDA Regulations Production 52

Agency IQ

JULY 22, 2024

BY WALKER LIVINGSTON, ESQ 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 59

Regulations 59

Drug Patent Watch

FEBRUARY 27, 2025

One key strategy is to conduct thorough market research and stay up-to-date on the latest patent laws and regulations in each country where you plan to operate. By building strong relationships with local stakeholders, you can also stay ahead of the competition and stay informed about emerging trends and opportunities.

Marketing 52

Marketing Drugs Regulations Pharmaceutical Companies 52

BioPharma Drive: Drug Pricing

JUNE 28, 2023

A new rule proposed by antitrust regulators would ask companies to provide additional information about planned mergers to help the Federal Trade Commission keep pace with increased deal volume and complexity.

Regulations 130

Regulations 130

FDA Law Blog: Biosimilars

MARCH 31, 2024

Gibbs — On March 21, 2024, the House Energy and Commerce held a subcommittee hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.” By Ana Loloei & Jeffrey N. FDA, which was not invited to participate, would surely have concurred.

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Regulations FDA Laboratories Disease 64

Drug Patent Watch

DECEMBER 10, 2024

Improved Security and Intellectual Property Protection : Integrated CDMOs can more easily control which employees have access to information, enhancing the security of intellectual property.

Drug Development 96

Drug Development Compliance Pharmaceutical Companies Drugs 96

FDA Law Blog: Biosimilars

MARCH 10, 2024

Hyman, Phelps & McNamara Director Larry Houck will participate as a panelist focusing on this timely topic at the Food and Drug Law Institute’s (“FDLI’s”) Legal and Practical Issues in Cannabis Regulation Conference next month. Additional information, including a preliminary agenda, is available at the conference webpage here.

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Regulations FDA Production Drugs 64

Drug Target Review

DECEMBER 20, 2024

However, he believes that these fears will dissipate as pharma companies come to realise that AI firms like Unlearn adhere to stringent data control measures, ensuring the ethical use of patient information. Regulators care a lot about controlling the Type 1 error rate of the clinical trial, Smith notes.

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Clinical Trials Trials Pharmaceuticals Drug Development 128

FDA Law Blog: Biosimilars

FEBRUARY 7, 2024

The CSA and regulations promulgated by DEA regulate the sale, import, and export of tableting machines the same as they regulate List I chemicals. In brief, in regard to proof of identity, the seller must obtain sufficient information to identify and document the identity of the purchaser. 21 U.S.C. § 1310.06.

Regulations 116

Regulations Government Compliance Production 116

Perficient: Drug Development

JANUARY 6, 2025

Universal design (UD) in healthcare ensures that facilities, services, and information are accessible to everyone, regardless of their physical abilities. This approach encompasses architectural designs, patient communication methods, and even the format of health information.

Compliance 52

Compliance Regulations Treatment Production 52

Agency IQ

FEBRUARY 23, 2024

BY WALKER LIVINGSTON, ESQ The Office of Information and Regulatory Affairs (OIRA) has completed its review of the Safer Communities by Chemical Accident Prevention rule that would amend some of the agency’s risk management program procedures for facilities to focus on protecting vulnerable communities.

Regulations 59

Regulations 59

Advarra

FEBRUARY 4, 2025

At a busy research site, a clinical trial is ready to launch but its stuck in limbo over a single paragraph in the informed consent form (ICF). Meanwhile, Illinois has specific requirements relating to the Genetic Information Privacy Act (GIPA), which mandates unique consent language to address how genetic data will be stored and used.

Clinical Trials 52

Clinical Trials Trials Compliance Therapies 52

DrugBank

OCTOBER 30, 2024

You no longer have to worry about infrastructure limitations or data bottlenecks; instead, you can enjoy seamless access to critical information that keeps pace with your research. From encryption to compliance with industry regulations, Snowflake has you covered, so you can focus on your work with confidence.

Production 74

Production Clinical Trials Packaging Compliance 74

Drug Channels

MARCH 4, 2025

Pharmacies and Pharmacy Benefit Managers , Dr. Fein will provide invaluable insights to help you and your team stay informed about this rapidly evolving market. Register now to stay informed and ahead of the curve on the PBM industry! Or, download this spreadsheet and email your registrants information to dcisupport@hmpglobal.com.

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Pharmacy Specialty Pharmacies Marketing Drugs 94

ACTO

DECEMBER 17, 2024

The Foundational Pillars ACTO believes in implementing four foundational pillars that will ensure responsible AI solutions that address pharmas highly regulated parameters, while providing value. RAG is an AI framework that combines information retrieval systems with large language models (LLMs) to generate more accurate and relevant text.

Government 52

Government Compliance Pharmaceutical Companies Pharmaceuticals 52

Advarra

NOVEMBER 14, 2024

The draft guidance highlights several key points pertinent to international trials: Diversity of expertise: KOLs with varied backgrounds and expertise enhances the DMC’s ability to address complex clinical and safety issues, and is crucial for interpreting data accurately and making informed decisions. local standards of care).

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Clinical Trials Trials International Clinical Research 97

Perficient: Drug Development

AUGUST 19, 2024

The vision is that all of the data can be aggregated, harmonized and used for better, faster and more informed decision making for Financial and Non Financial Risk Management. where’s my Insight”) The primary goal of data management, sourcing and aggregation effort will have to be converting data into informational insights.

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Regulations Marketing Government Compliance 109

Broad Institute

MARCH 12, 2025

These methods, however, fail to capture spatial information such as the effects from, or on, neighboring cells, which can provide important clues to a cell or genes role in health and disease.

RNA 92

RNA Science Research Disease 92

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). RFIs must be addressed in the clinical trial information system (CTIS) within 10 calendar days for validation and 12 calendar days for assessment.

Clinical Trials 52

Clinical Trials Trials Regulations Pharmaceutical Companies 52

PPD

MAY 7, 2024

The European Union (EU) is on the verge of a significant shift as it prepares to implement new health technology assessment (HTA) regulations in 2025. Challenges and opportunities of the new EU HTA regulation The implementation of centralized HTA presents both opportunities and challenges for pharmaceutical companies.

Regulations 52

Regulations Pharmaceutical Companies International Pharmaceuticals 52

FDA Law Blog: Biosimilars

JUNE 12, 2024

The GAO Report provides an overview of the rulemaking process for OTC hearing aids, the resulting OTC hearing aid regulatory scheme, and FDA’s interaction with other agencies when regulating OTC hearing aids. While helpful background, it’s not new information.

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FDA Regulations Treatment Licensing 111

Agency IQ

MAY 28, 2024

BY WALKER LIVINGSTON, ESQ 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). This final rule follows a proposed rule released almost exactly one year ago. Fill out the form to read the full article.

Regulations 59

Regulations 59

FDA Law Blog: Biosimilars

JULY 23, 2024

Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term.

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FDA Drugs Pharmacokinetics Production 105

Agency IQ

AUGUST 2, 2024

This recurring feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more.

Regulations 59

Regulations 59

Agency IQ

MAY 31, 2024

This recurring feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more.

Regulations 59

Regulations 59

Agency IQ

MAY 3, 2024

This recurring feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more.

Regulations 59

Regulations 59

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. Amid a constantly evolving global regulatory environment, companies must be proactive, well-informed and flexible.

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Compliance Regulations Production Trials 98

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.” FDA investigators routinely share their names, titles, contact information, and, when appropriate, reasons for conducting the inspection. By Sarah Wicks & Anne K. Ask clarifying questions.

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FDA Compliance Laboratories International 111

Agency IQ

FEBRUARY 2, 2024

This ongoing feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more. Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities.

Regulations 59

Regulations 59

Agency IQ

JANUARY 4, 2024

This ongoing feature compiles information from across EU agencies and institutions to deliver an overview of chemicals-related regulatory actions likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more. Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities.

Regulations 59

Regulations 59