FDA Law Blog: Biosimilars

NOVEMBER 30, 2023

The 2023 Food and Drug Law Institute’s (“FDLI”) Enforcement, Litigation and Compliance Conference will boast two speakers from Hyman, Phelps & McNamara, P.C. (“HPM”), The conference will also include its annual panel discussion with FDA’s Center Compliance Directors. Blumberg Memorial Lecture. next week, on December 6-7, 2023.

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Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. For clinical development organizations, an effective CAPA serves as an essential compass, directing a path towards continuous improvement while maintaining steadfast regulatory compliance.

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ProRelix Research

DECEMBER 28, 2023

Considering the crucial role that the information generated from clinical trials play in the approval of new drugs, biological, and medical devices, it is only logical that the data garnered […] The post Clinical Data Standardization in Clinical Trials: FDA Compliance in Clinical Data Management appeared first on ProRelix Research.

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Advarra

DECEMBER 14, 2023

This enables higher levels of training compliance over the course of study conduct, as well as the necessary understanding of trial activities to perform the right task at the right time. In addition, providing CROs and sponsors visibility to site training compliance allows them to provide additional support and mitigate risk if necessary.

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thought leadership

AUGUST 1, 2023

Welcome to Part 2 of our blog series on "What You Need to Know About GxP Independent Compliance Audits." In Part 1 , we discussed the importance of GxP audits, the different audit types, and why utilizing independent auditors is crucial for successful compliance assessments.

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Perficient: Drug Development

AUGUST 17, 2023

The ripple effect will be essential as EV penetration continues to rise in the United States, although it also opens a whole new area of regulatory compliance with batteries which was not as big of a factor when EV penetration was much lower. Regulatory battery compliance cannot be an afterthought for OEMs manufacturing EVs and batteries.

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FDA Law Blog: Biosimilars

NOVEMBER 13, 2023

On January 23-24, 2024, the American Conference Institute (“ACI”) will host its “ Advanced Legal, Regulatory and Compliance Forum on OTC Drugs ” conference at the Sofitel New York, NY.

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Perficient: Drug Development

SEPTEMBER 11, 2023

Already reviewed by Perficient, BES provides a secure and efficient portal to exchange documents, information, and communications for consumer compliance and Community Reinvestment Act (CRA) examinations. This month, the Federal Deposit Insurance Corporation (FDIC) launches it new Banker Engagement Site (BES) through FDIC connect.

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FDA Law Blog: Biosimilars

JANUARY 22, 2024

Claud — The Office of Compliance (OC) at FDA’s Center for Drug Evaluation and Research (CDER) had a role in many of the major public health enforcement matters you may have read about last year. OC devoted a lot of resources to its compliance efforts directed at human drug compounding. By John W.M.

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FDA Law Blog: Biosimilars

DECEMBER 7, 2023

Gonzalez — The annual Enforcement, Litigation, and Compliance Conference put on by the Food and Drug Law Institute (“FDLI”) took place in Washington this week. By Steven J. There were too many interesting panels and discussions to mention them all, but presentations about DOJ’s and FDA’s coordination deserve some special mention.

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SCIENMAG: Medicine & Health

JUNE 30, 2023

Compliance is critical for large economies, industry regulations, and enterprise operations. BGI Genomics prioritizes compliance management and strictly follow laws, regulations, and international practices while conducting business globally.

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thought leadership

MARCH 25, 2024

What is PIPL/PIPA? Personal Information Protection Law (PIPL) was approved in China on August 20, 2021. It was the first comprehensive data protection legislation in the region.

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Fierce BioTech

FEBRUARY 13, 2024

Streamlining Compliance: Outsourcing combined services and technology in pharmacovigilance and regulatory affairs Biotech and pharma companies are already tapping into the benefits of outsourcing. They can, however, get much more out of the strategy by leveraging one vendor for both technology and regulatory services.

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Advarra

SEPTEMBER 8, 2022

After platform review, if a decision is made to validate, staff should generate documentation to ensure Part 11 compliance. As the first requirement in Part 11 compliance, validation is systematic documentation for a system’s requirements. The post Beginner’s Guide to 21 CFR Part 11 Compliance appeared first on Advarra.

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Agency IQ

APRIL 12, 2024

EPA releases final PFAS drinking water regulations – with five-year compliance timeline The EPA has released its much-awaited National Primary Drinking Water Regulation for six different PFAS. Finalized trigger levels for compliance monitoring frequency are set at one-half the level of the MCLs (e.g. for the HI). version 2.0).

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thought leadership

FEBRUARY 29, 2024

In the complex world of drugs and medical devices, where every pill, syringe, and implant holds the potential to impact lives profoundly, ensuring the utmost safety, efficacy, and quality is paramount. This assurance is not left to chance but is meticulously governed by a set of regulations known as GxP.

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Drug Channels

APRIL 19, 2021

Informa Connect’s Compliance Congress for Specialty Products. June 22-24, 2021 | Virtual Event www.informaconnect.com/specialty-compliance/. Up your compliance game at this important event serving the unique sector of Specialty Products, the 7th annual Virtual Compliance Congress for Specialty Products.

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Agency IQ

APRIL 12, 2024

BY WALKER LIVINGSTON, ESQ The EPA has released its much-awaited National Primary Drinking Water Regulation for six different PFAS. The finalized rule includes new individual limits for some PFAS and gives water systems five years to be able to comply with the drinking water contaminant levels.

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The Pharma Data

NOVEMBER 23, 2020

On February 7, 2020 the NYSE American notified the Company that it accepted the Company’s plan to regain compliance before November 25, 2020 , the end of the compliance plan period. This date has now been extended to May 25, 2021. About Synthetic Biologics, Inc. Synthetic Biologics, Inc.

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The Pharma Data

MARCH 9, 2021

Eli Lilly and Company (NYSE: LLY) today announced the upcoming retirement of two executive committee members and the naming of their successors in the company’s manufacturing operations and ethics and compliance organizations. Hernandez and Weems will report to David A.

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Perficient: Drug Development

DECEMBER 18, 2023

In the fast-paced realm of finance, the significance of regulatory risk and compliance management practices cannot be overstated. The Role of Regulatory Risk and Compliance 1. Compliance with these legal obligations is not only mandated by regulatory authorities but also necessary for maintaining an institution’s reputation.

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FDA Law Blog: Biosimilars

JANUARY 4, 2024

This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing and distribution.

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SCIENMAG: Medicine & Health

JUNE 26, 2023

Orlando, Fla., June 27, 2023 – Hand hygiene is the simplest, most effective way to prevent the spread of infections in healthcare, yet healthcare worker adherence is often low.

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Drug Discovery World

MAY 8, 2024

Study drug compliance was high; 72.7% Including a four-week follow-up after treatment ended, continuous abstinence from weeks 9 to 16 remained higher in the cytisinicline group than the placebo group at 23.4% versus 13.2%, respectively (OR, 2.0; [95% CI, 0.82-5.32]).

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Perficient: Drug Development

JULY 27, 2023

The Community Reinvestment Act (CRA) is a federal law in the US that promotes the interest of financial service firms to serve their communities’ credit needs, including low- and moderate-income neighborhoods.

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Perficient: Drug Development

FEBRUARY 15, 2024

These DFS500 amendments signal a crucial shift in the regulatory landscape, emphasizing the imperative for robust governance, risk management, and compliance frameworks across the financial industry. Impacted institutions are subject to significant fines relative to the level of non-compliance identified by the regulators.

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Perficient: Drug Development

FEBRUARY 15, 2024

The NYSDFS Part 500 amendments signal a crucial shift in the financial services regulatory landscape and underscore the importance of robust governance, risk management, and compliance frameworks. Impacted institutions are subject to significant fines relative to the level of non-compliance identified by the regulators.

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Drug Discovery World

MARCH 16, 2023

Susan Rienow, President-Elect, ABPI, said: “Such measures are never taken lightly, but will ensure a rapid return to industry compliance standards as set out in the ABPI Code of Practice.” In addition, the Board has stipulated a number of additional actions to demonstrate a rapid return to industry compliance standards.

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Perficient: Drug Development

MARCH 12, 2024

Whether it’s streaming processes, improving citizen services, or ensuring compliance, our specialized knowledge positions us as a go-to partner for government projects. Looking Ahead We are excited about the new opportunities the Government Specialization brings and are committed to continuing our journey of innovation and excellence.

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DS in Pharmatics

MAY 4, 2023

Diagnosing illnesses and monitoring health is increasingly reliant on utilizing software. For patients, manufacturers must maintain standards and regulations. Companies can be concerned with challenges concerning updated legislation such as the EU’s MDR.

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Drug Discovery World

JANUARY 5, 2023

PharmaLex is a global team of scientific, regulatory and safety and compliance (GxP) experts that provide strategic guidance and regulatory support to biopharma companies throughout a product’s lifecycle. .

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FDA Law Blog: Biosimilars

MAY 16, 2024

But there has been a recent string of large civil monetary settlements, some in the millions of dollars, to resolve allegations that hospitals’ non-compliance with the federal Controlled Substances Act (“CSA”) and DEA regulations allowed employees to divert staggering quantities of controlled substances.

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Drug Discovery World

APRIL 3, 2023

In this eBook you will learn: The benefits of implementing an ELN in your laboratory How to choose the right ELN based on your specific needs and challenges The essential features of an ELN, including security and compliance The cost savings and ROI associated with implementing an ELN As a bonus, we’ve included the Ultimate ELN Checklist , to help (..)

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thought leadership

MAY 13, 2024

In today's dynamic business landscape, organizations in the drug, biologics, and medical device industries face the dual challenge of delivering quality products while managing tighter budgets and ensuring compliance with evolving regulatory standards.

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Perficient: Drug Development

DECEMBER 27, 2023

YOU MAY ENJOY: Regulatory Reporting in Financial Services Modernizing CRA Regulations Managing compliance risk frameworks in alignment with existing risk profiles is crucial as customer needs evolve. Contact us today to discuss in depth how we can help tackle your business challenges.

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thought leadership

MAY 3, 2024

Particularly, within the European Union (EU) and the United Kingdom (UK), QP audits play a pivotal role in maintaining compliance with stringent regulatory standards. One crucial aspect of this assurance lies in the oversight provided by Qualified Persons (QPs) and the audits they conduct.

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FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

In response, we learned that only about seven – and certainly less than 10 – RIEs for manufacturing compliance have been performed at drug facilities in the last 30 months.

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