Scienmag

APRIL 12, 2021

UMD-led study warns cascading effects of salts require coordinated management and regulation to avoid contaminating natural resources Credit: Sujay Kaushal When winter storms threaten to make travel dangerous, people often turn to salt, spreading it liberally over highways, streets and sidewalks to melt snow and ice.

Contamination 98

Contamination Regulation Medicine 98

Cloudbyz

MARCH 3, 2023

Resource Constraints Mid-size CROs often have limited resources compared to larger CROs, making it challenging to compete on scale. They can also leverage strategic partnerships and collaborations with other organizations to share resources and expand their capabilities.

Compliance 88

Compliance Branding Packaging Packaging 88

Pharmaceutical Technology

FEBRUARY 24, 2023

She also cautioned against believing that all of the problems with Europe’s medicines can be solved with regulation. European Parliament for Romania member Cristian-Silviu Busoi told the webinar that the legislation is out of date for clinical trials, comparing the EMA’s resources unfavourably with the staffing of China’s NMPA.

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Regulation Clinical Trials Clinical Trials Medicine 162

FDA Law Blog

MARCH 19, 2024

Mullen’s extensive experience and contributions to the field of in vitro diagnostic (IVD) regulation. AMDM facilitates educational resources within the in vitro diagnostic industry. IVD Overview and Update,” will cover recent developments in IVDs, including the proposed LDT regulation. Mr. Gibbs’ presentation, entitled “U.S.

In-Vitro 59

In-Vitro Manufacturing Regulation Development 59

FDA Law Blog

MAY 22, 2023

The California Department of Food and Agriculture (CDFA) issued regulations implementing Proposition 12 on September 1, 2022, but their implementation was enjoined until July 1, 2023, pending the Supreme Court’s decision. Our focus is on the decision’s practical impact, which could be felt almost immediately.

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Regulation Sales 45

Scienmag

AUGUST 4, 2020

Led by Boyce Thompson Institute’s Andrew Nelson, four partners will identify RNA modifications and develop resources that may lead to hardier crops Credit: Photo credit: Anna Nelson Dittrich ITHACA, NY, August 4, 2020 — RNA perform a variety of functions in cells, helping with everything from regulating genes to building proteins.

RNA 74

RNA Bioinformatics Protein Regulation 74

Camargo

SEPTEMBER 8, 2021

devices must be regulated as devices, and drugs—if they do not also satisfy the device definition—must be regulated as drugs.”. PANDAs have historically been overseen by the FDA’s Office of Generic Drugs and thus regulated more like a generic than an NDA. Final Regulation Issued for “Intended Use”.

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Development Regulation Production Drugs 186

XTalks

SEPTEMBER 15, 2022

In this episode of the Xtalks Food Podcast, Sydney talks about four potential new food industry regulations that food and beverage companies should look out for this year, including changes to the FDA’s definition of “healthy,” labeling clarity on lab-grown meat, regulating heavy metals in baby food and cannabinoid regulations.

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Regulation Production Marketing Development 52

XTalks

MARCH 7, 2024

Earlier this week, the US Food and Drug Administration (FDA) took a significant step forward in regulating dietary supplements. It is an essential resource for understanding how to comply with federal regulations concerning NDINs, ultimately contributing to the safety and efficacy of dietary supplements available to consumers.

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Regulation Manufacturing Compliance Marketing 105

pharmaphorum

SEPTEMBER 29, 2022

The FDA’s General Approach to Regulating mHealth Products. Food and Drug Administration (FDA) regulation as a medical device. Determining whether a product is a medical device subject to FDA regulation necessarily begins with understanding the FDA regulatory definition of ‘medical device’. not a medical device, ii.

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Development Regulation Production Life Science 104

Scienmag

AUGUST 5, 2020

A long-running national collaboration has produced a comprehensive catalogue of the molecular elements that regulate our genes Credit: Ella Maru Studio A 17-year research project has generated a detailed atlas of the genome that reveals the location of hundreds of thousands of potential regulatory regions – a resource that will help all human (..)

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Genome Genomics Regulation Gene 53

Cloudbyz

APRIL 27, 2023

By automating repetitive and time-consuming tasks, organizations can focus on the strategic aspects of their operations and ensure that they remain compliant with complex and ever-changing regulations. Organizations must ensure that their automated processes and tools are transparent, auditable, and adhere to regulatory requirements.

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Clinical Trials Clinical Trials Trials Compliance 89

FDA Law Blog

FEBRUARY 7, 2023

Lenz, Principal Medical Device Regulation Expert — For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market. There are many resources that provide information and guidance for each of these required elements.

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Compliance Marketing Regulation Development 98

pharmaphorum

DECEMBER 9, 2021

Instead, Britain needs to “strike a balance between forging its own path as a sovereign regulator whilst ensuring strategic partnerships with other leading regulators, including the European Medicines Agency (EMA), are nurtured” it recommends. “As The same principle applies to regulation,” she went on. Life sciences future.

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Regulation Medicine Life Science Development 98

Worldwide Clinical Trials

APRIL 3, 2024

Complying with Unique Radiopharmaceutical Regulations The regulatory landscape for radiopharmaceuticals is intricate, reflecting the drugs’ complexity. By emphasizing transparency and patient autonomy, trials can maintain ethical standards while fostering trust and participation.

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Trials Clinical Trials Clinical Trials Compliance 183

pharmaphorum

SEPTEMBER 8, 2021

.” Fewer staff will therefore be asked to cover more ground with fewer resources, all whilst operating under a pay freeze, they claim. “We will continue to be a world-class regulator that delivers the right outcomes for patients, while we modernise the services we provide to industry, and remain financially stable.”

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Regulation Life Science Medicine Production 105

Cloudbyz

MARCH 21, 2024

Resource Allocation: Study coordinators can redirect their time and efforts from manual redaction tasks to more valuable activities such as patient care, protocol compliance, and data analysis. Example Metric: Achieve 100% compliance with privacy regulations. Example Metric: Reduction in manual redaction time by 80%.

Compliance 52

Compliance Regulation Production 52

Cloudbyz

MARCH 1, 2023

Conducting clinical trials requires significant investments of time and resources, including the management of budgets and payments. Digital tools provide a detailed audit trail that can be used to demonstrate compliance with regulations such as the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines.

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Clinical Trials Clinical Trials Trials Compliance 94

FDA Law Blog

JANUARY 22, 2024

The tools it uses to accomplish that mission include those designed to help regulated entities that want to follow best public health practices, like guidances, public notifications, and requests for information. OC devoted a lot of resources to its compliance efforts directed at human drug compounding. Clinical Trials.

Compliance 59

Compliance Clinical Trials Clinical Trials Regulation 59

pharmaphorum

APRIL 14, 2021

A coalition of European academy networks has called upon European Union (EU) leaders to rethink how General Data Protection Regulation (GDPR) rules are applied to health data. Sharing pseudonymised personal health data for public sector research, they went on, is also essential to making most effective use of limited resources. “It

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Research Regulation Genome Genomics 145

pharmaphorum

NOVEMBER 24, 2021

The Government has committed to relooking at regulation as it determines its own independent trading policy. For any reform to be a success, the MHRA must remain independent, well-resourced and internationally connected. The new Life Sciences Vision details priority areas for enhancing regulation.

Life Science 98

Life Science Regulation Medicine Vaccination 98

Cloudbyz

OCTOBER 19, 2023

Site Selection: Data-driven site selection improves trial success rates and reduces resource wastage. Site Training: Offers online training modules and resources for investigators and site staff. Faster Trial Start-up: Streamlined processes lead to quicker site activation, reducing the time it takes to initiate trials.

Clinical Trials 93

Clinical Trials Clinical Trials Trials Compliance 93

FDA Law Blog

SEPTEMBER 11, 2023

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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Regulation Marketing Manufacturing Medicine 64

pharmaphorum

NOVEMBER 26, 2020

He told Sky News that additional costs, bureaucracy and delays could follow a no-deal Brexit, or an agreement failing to address the complexity of drug regulation. As companies begin to seek approval from the regulator for new COVID-19 vaccines, it’s critical that we get the roll out right.

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Vaccination Vaccine Life Science Regulation 105

Pharma Marketing Network

JULY 27, 2023

This could include access to educational resources, evidence-based studies, or training opportunities. These resources can prove indispensable for HCPs and reinforce your commitment to their success and patient care. Ensure that your organization complies with all relevant regulations and guidelines. Transparency is also key.

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Compliance Development Clinical Trials Clinical Trials 98

World of DTC Marketing

FEBRUARY 16, 2022

CSR means that a company should self-regulate its actions and be socially accountable to its customers, stakeholders, and the world. Socially responsible companies use their position and resources for something more than pleasing their shareholders and increasing their bottom line. Pha a fails in this.

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Pharma Companies Regulation Vaccination Vaccine 178

The Pharma Data

JUNE 2, 2022

Today’s Supplement Your Knowledge resources will provide reliable information about the potential benefits and risks associated with dietary supplements, such as vitamins, minerals, and herbs, they may consume. More than half of all Americans take dietary supplements daily or on occasion. Source link: [link].

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Regulation Production Cosmetics Nurses 52

Pharma Marketing Network

JULY 19, 2023

This is because the pharmaceutical industry is highly regulated, and businesses need to find creative ways to reach their target audience and educate them about their products and services. Be compliant: Content marketing in the pharmaceutical industry is subject to strict regulations.

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Sales Marketing Branding Production 98

pharmaphorum

JULY 21, 2022

The pharmaceutical industry has long been highly regulated to help ensure quality and safety across all aspects of its business. As a result, some businesses have been forced in the last 18 months to make risk-based decisions based on the resources available to them rather than the quality assurance of a product.

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Compliance Regulation Manufacturing Contamination 98

Scienmag

MARCH 25, 2021

could dramatically […].

Regulation 56

Regulation 56

XTalks

NOVEMBER 2, 2020

The requirements come from two specific FSMA regulations: the Preventive Controls for Human Food (PC Human Food ) and Produce Safety. And under three FSMA regulations, suppliers may also use third-party audits to verify their activities. Related: Is the FDA Doing Enough to Regulate Added Chemicals in Foods?

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Regulation Contamination Development Production 98

Pharma Marketing Network

JULY 10, 2023

It can be a complex and challenging process, as pharmaceutical companies must adhere to strict regulations while also developing creative and effective marketing campaigns. This can make it difficult for pharmaceutical companies to develop and implement marketing campaigns that comply with all applicable regulations.

Marketing 40

Marketing Regulation Branding Production 40

Cloudbyz

MARCH 24, 2023

Understand global regulatory implications For any organization considering this transition, it is important to understand the regulatory implications and consider the relevant federal laws and regulations that may be impacted. Engaging and collaborating with technology companies will lead to better outcomes.

Clinical Trials 93

Clinical Trials Clinical Trials Trials Regulation 93

CTTI (Clinical Trials Transformation Initiative)

JANUARY 9, 2024

The group of 16 patients, caregivers, and patient group representatives meets with the FDA several times a year and discusses a variety of topics such as improving communication, education, and patient engagement related to medical product regulation. Those selected to the PEC are expected to serve for two years.

Clinical Trials 124

Clinical Trials Clinical Trials Trials Regulation 124

Advarra

AUGUST 31, 2022

Developing a regulatory pathway assessment (RPA) is a formal exercise for any new company or device to establish the way a regulator may accept the device in terms of risk-benefit. Without these factors being well constructed and thought out, discussions with regulators could be a challenge. Meeting with the Regulators.

Research 52

Research Regulation Clinical Trials Clinical Trials 52

Cloudbyz

APRIL 6, 2023

This automation saves research institutes time and resources, enabling them to focus on more critical tasks, such as data analysis and research. Cloudbyz UCTMS helps research institutes ensure that their trials comply with all applicable regulations and guidelines.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Research 52

Drug Channels

FEBRUARY 21, 2023

12 chapters, 480+ pages, 241 exhibits, 900+ endnotes: There is nothing else available that comes close to this valuable resource. This report—our fourteenth edition—remains the most comprehensive, fact-based tool for understanding the entire U.S. drug pricing, reimbursement, and dispensing system. The 2023 Economic Report on U.S.

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Pharmacy Drugs Licensing Licensing 76