XTalks

MARCH 7, 2024

The agency released a final guidance entitled “ Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry.” The new guidance is structured in a question-and-answer format, designed to address the intricacies of the NDIN submission and review process comprehensively.

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FDA Law Blog

MARCH 21, 2024

Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance. By John W.M. As readers of our blog know, MoCRA was a significant change to regulation of cosmetics.

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Camargo

NOVEMBER 15, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA Guidance Addresses Real-World Evidence Data Standards. But what real-world evidence (RWE) would be accepted, and in what format?

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ACRP blog

AUGUST 23, 2023

The latest regulatory guidance addressing elements of decentralized clinical trials (DCTs) is the draft ICH E6(R3) Good Clinical Practice (GCP) guideline from the International Council for Harmonization (ICH). Much like recent guidances proposed by the U.S. Q: When final guidances are eventually settled upon in the U.S.

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FDA Law Blog

FEBRUARY 9, 2024

Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. The guidance addresses the use of DHTs in clinical investigations of drugs, biologics, and medical devices.

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FDA Law Blog

JANUARY 8, 2024

In a “hot” deal market, its worthwhile reiterating the fundamentals of regulatory due diligence that don’t change, no matter how attractive the deal or how short the window is to seize the opportunity. Having the right diligence team is critical because proper risk assessment of regulatory risk requires a broad range of expertise.

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Regulation Compliance Marketing 69

Camargo

MAY 10, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA Issues Final Guidances on Issues Arising from COVID-19. FDA’s Accelerated Approval Program Comes Under Fire. emphasis added).

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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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Pharma Marketing Network

JULY 26, 2023

While maintaining a vigilant approach to marketing compliance is crucial, the FDA may be strategically choosing to address more immediate public health concerns, leading to fewer marketing violation letters being issued.

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FDA Law Blog

DECEMBER 15, 2022

By Riëtte van Laack — On December 7, 2022, FDA announced the availability of the final guidance regarding the enforcement policy for homeopathic drug products. It issued a draft guidance in 2017 which was subsequently revised in 2019. It issued a draft guidance in 2017 which was subsequently revised in 2019.

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pharmaphorum

OCTOBER 27, 2022

Why is guidance needed? Uses of social media is continually expanding and it has been difficult for companies to apply general advertising rules and guidance to the modern world. What is the scope of the Guidance? It identifies the most used social media and digital channels and sets out specific guidance for each.

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FDA Law Blog

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. This guidance document is still in effect today. products intended for medical purposes).

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Manufacturing Regulation Compliance Production 98

ACRP blog

AUGUST 23, 2023

The latest regulatory guidance addressing elements of decentralized clinical trials (DCTs) is the draft ICH E6(R3) Good Clinical Practice (GCP) guideline from the International Council for Harmonization (ICH). Much like recent guidances proposed by the U.S. Q: When final guidances are eventually settled upon in the U.S.

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Advarra

JUNE 26, 2023

A successful FDA inspection can pave the way for continued operations, product approvals, and in some cases, even accelerated go-to-market regulatory pathways. This blog provides key insights and guidance for sponsors and sites as they work to mitigate risks and ensure compliance for a successful FDA inspection.

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Advarra

JULY 27, 2022

This guidance focuses on the commercial phase of the product lifecycle and applies to pharmaceutical drug substances and products – both chemical and biological – that require a marketing authorization. Managing regulatory submissions through increased product and process knowledge. The Impact of This Guidance.

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Production FDA Approval Compliance Marketing 52

CTTI (Clinical Trials Transformation Initiative)

JANUARY 10, 2024

Timely, accurate, and complete registration and reporting of summary results information for applicable clinical trials on ClinicalTrials.gov allows access to current research and evidence for all partners in the clinical trials enterprise, including patients, providers, sponsors and investigators, regulators, payers, and health system leaders.

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Camargo

SEPTEMBER 15, 2020

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explore how those changes could impact your program. FDA issues guidance on inspections during COVID-19 pandemic. Fitbit developing algorithm COVID-19 early detection.

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FDA Law Blog

FEBRUARY 19, 2024

Loloei is a 14-year veteran of the FDA, where most recently she served as a Senior Regulatory Counsel in the Office of Policy at CDRH. Loloei will focus on guiding clients through complex premarket and postmarket regulatory requirements and assisting with the management of total product life-cycle matters. While at FDA, Ms.

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pharmaphorum

JULY 1, 2022

Navigating The MDR and IVDR and Best Strategies for Compliance. In addition, the conference will consider the evolving regulatory landscape for digital health software. Gain insights from pharma regulatory experts in compliance and companion diagnostics. SAE Media Group’s Inaugural Conference…. 14 – 15 November 2022.

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Regulation Compliance Manufacturing Marketing 52

FDA Law Blog

APRIL 8, 2024

Those numbers are the stars in the manufacturing universe that CDER uses to plot its regulatory course, so it’s of interest to see how they have remained consistent even if OPQ didn’t take the next step of connecting the points in those constellations. The role of technology on quality was another feature.

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FDA Law Blog

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. This guidance document is still in effect today. products intended for medical purposes).

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Drug Discovery World

MAY 8, 2024

Fiona Maini , Senior Director Global Compliance & Strategy, at Medidata looks at the rise of artificial intelligence (AI) and machine learning (ML) within life sciences and the applications for the technology in clinical trials. Progress is ongoing on this front, with the European Medicines Agency (EMA) developing its own guidance.

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Cloudbyz

MAY 5, 2023

Executive Summary Risk-Based Monitoring (RBM) is an approach to clinical trial monitoring that optimizes the use of resources by focusing on trial risks, with the goal of ensuring patient safety, data quality, and regulatory compliance. Challenges and Best Practices 6.1.

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WCG Clinical

APRIL 3, 2023

Each business day, the new FDAnews will deliver precisely what pharmaceutical and medical device manufacturers have told us they need to know about regulatory compliance and good manufacturing practices,” said Terri Moench, RPh, MS, President, Research Solutions for WCG.

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Camargo

NOVEMBER 11, 2020

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Guidance Issued on Referencing Approved Drug Products in ANDA Submissions. Manager of Regulatory Compliance. Co-Authors: Jenny Fielder.

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Cloudbyz

JULY 19, 2023

This blog delves into the significance of pharmacovigilance in clinical trials, highlighting its role in participant safety, data integrity, and regulatory compliance. It highlights the importance of standardized data collection, timely reporting, and adherence to regulatory requirements.

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FDA Law Blog

AUGUST 8, 2023

Lewis, Senior Regulatory Device & Biologics Expert — Please sing to the tune of “ Honesty ,” by Billy Joel: Nitrosamines, it’s such an ugly word, In pharmaceuticals’ impurity. An earlier FDA guidance, revised in 2021. By Douglas B. Farquhar & Richard A. Nitrosamines are hardly ever good, Now FDA has issued policy.

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Cloudbyz

MARCH 5, 2023

The Medical Device Coordination Group (MDCG) is a regulatory body in the European Union (EU) responsible for developing guidelines and regulations related to medical devices. MDCG regulatory reporting guidelines are the set of guidelines provided by the MDCG that specify the reporting requirements for medical device manufacturers in the EU.

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Camargo

DECEMBER 22, 2021

One of Camargo’s differentiating offerings is the portfolio analysis, a high-level, integrated evaluation of the scientific, medical, regulatory, and commercial viability of each product within a sponsor’s portfolio. Camargo is adept at helping sponsors determine the most appropriate regulatory pathway (e.g., Incentive Programs.

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Advarra

JUNE 14, 2022

It’s critical for the IRB to follow appropriate regulations and guidance in its reviews, ensure reviews are conducted free of bias and conflict of interest (COI), and conduct due diligence to confirm quality is upheld for the studies they oversee. Annual reports to confirm ongoing compliance and maintain accreditation. IRB Clients.

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pharmaphorum

SEPTEMBER 29, 2022

If so, developers must develop and execute on a regulatory strategy. Determining whether a product is a medical device subject to FDA regulation necessarily begins with understanding the FDA regulatory definition of ‘medical device’. More information about this process may be found in FDA’s 513(g) Guidance Document.

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FDA Law Blog

SEPTEMBER 1, 2021

For companies that play in the FDA-regulated space, however, a focused regulatory diligence should be a high priority. Of course a solid understanding of the regulatory compliance status of a target company is necessary for pure business reasons.

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FDA Law Blog

SEPTEMBER 6, 2023

As predicted in an earlier blogpost , FDA last week released a draft guidance that provides a pathway for generic drug manufacturers to secure a meeting with FDA so that affected companies can get answers to their questions in these circumstances. And the Guidance may be used as leverage to secure action from FDA on a meeting request.

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Cloudbyz

JUNE 11, 2023

DCTs employ digital platforms for remote interaction and consultation, maintaining patient engagement and providing necessary support virtually, which may reduce appointment no-shows and increase protocol compliance. They often come with in-built compliance mechanisms to ensure adherence to regulations and good clinical practice guidelines.

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ACRP blog

MAY 17, 2023

Food and Drug Administration (FDA) draft guidance on decentralized clinical trials. This is a key step forward in providing much-needed regulatory clarity – yet questions remain. A peer-reviewed paper on FDA draft guidance on clinical trial diversity , emphasizing the role of DCTs in improving diversity, equity, and inclusion.

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ACRP blog

NOVEMBER 16, 2023

Institutions must establish stringent protocols to safeguard against potential misuse and ensure compliance with data privacy regulations when employing ChatGPT in research settings,” she adds. PI oversight of how ChatGPT is being used at a site is vital for ensuring the validity of changes being made to ICFs,” he says.

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ACRP blog

NOVEMBER 16, 2023

Institutions must establish stringent protocols to safeguard against potential misuse and ensure compliance with data privacy regulations when employing ChatGPT in research settings,” she adds. PI oversight of how ChatGPT is being used at a site is vital for ensuring the validity of changes being made to ICFs,” he says.

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